Pfizer Biotechnology Ireland - Environmental Protection · PDF fileThe Pfizer Biotechnology Ireland facility at Shanbally ... Separate dispensing areas are provided for handling buffer

Pfizer Biotechnology Ireland

2009 Annual Environmental Report

Integrated Pollution Prevention Control License

P0864-01

Executive Summary: The Pfizer Biotechnology Ireland facility at Shanbally Ringaskiddy

commenced operations under IPPC P0864-01 on June 26th, of 2009. 2009

was a very successful year for the facility, with the granting of the IPPC

license, completion of the validation programme and the awarding of a clinical

manufacturing license by the IMB. Through the remainder to the year a 100%

compliance level was achieved against all the permitted activities.

The facility is designed to use the Monoclonal antibody (Mabs) platform for

the production of Phase II and Phase III Clinical Trial medicinal products

The sites Environmental Management System has been based on the ISO

14001 model with a view to future certification to the standard. While the

facility has just commenced manufacturing its initial product a clear focus on

environmental awareness and sustainability has been marked by the

awarding of:

o the Sustainability award for 2009 by the ISPE International

Society of Pharmaceutical Engineering

o the 2009 CPD (Continuing Professional Development) Large

Sized Company Category Award

The facility was constructed using Pfizer’s ‘Green Building’ design philosophy

and this was instrumental in securing the Sustainability award

The award for Continuing Professional Development was presented “In

recognition of excellent and innovative organizational CPD practices which

helped successfully deliver, a new biopharmaceutical plant for Pfizer in

Ireland in less than two years.” The award was based on our learning and

development programs, including key environmental learning packages, with

a continued commitment to Learning and Development at Shanbally.

The Environmental Management Programme (EMP) outlined in this report will

demonstrate a focus on improved environmental performance, specifically in

the areas of water, energy and resource conservation. A phased plan has

been implemented geared towards continuous improvement in all business

areas not least of which is those areas of the sites which may have an

environmental impact. It is believed that substantial improvements and

benefits will be derived from these efforts in 2010.

Contents

1. Introduction 1.1 General

1.2 Facility Overview 1.3 Organisation Chart for Environmental Management 1.4 Water Emissions Monitoring Data

1.5 Air Emissions Monitoring Data 1.6 IPPC Licence Compliance 1.7 Noise Survey

1.8 Waste Arisings 1.9 Resource Utilisation 1.10 Environmental Incidents and Complaints 1.11 Genetically Modified Micro-Organisms

2. Management of the Activity 2.1 Introduction 2.2 Status Report on Schedule of Objectives and Targets (2009) 2.3 Environmental Management Plan 2009

3. Pollution Release and Transfer Register (PRTR)

4. Bund Integrity Assessment Report 5. Tank and Pipeline Testing and Inspection

6. Environmental liabilities and Residual Management 7. Licence Specific Reports Attachment 1 – Environmental, Health and Safety Policy

Attachment 2 - Energy Management audit

Attachment 3 – Site Noise Survey

Attachment 4 – Pipeline Test Report

Attachment 5 - Bund Integrity Report

Attachment 6 – ELRA: Environmental Liabilities Risk Assessment

Attachment 7 – DMP: Decommissioning Management Plan

Attachment 8 – PRTR: Pollution Release and Transfer Register

1. Introduction 1.1 General

At the Shanbally Biotechnology facility the responsibility for Environmental

Compliance and IPPC management rests with the Engineering and EHS

Team, where the specific Environment Health and Safety responsibilities

reside with the EHS Lead.

Over the past two years the Environmental focus has moved from

Construction and Commissioning activities through establishing the EHS

management system, with continuous improvement of those systems.

Pfizer Biotechnology’s Ireland’s Monoclonal Antibodies Small-scale Facility

was built using industry best practices for sustainability and Pfizer’s green

building guidelines that included the extensive re-use of existing assets,

waste minimization procedures, recycling utilization in both construction and

operations, the inclusion of energy-efficient fixtures and equipment, and

minimized air change rates to meet room comfort conditions and

classification standards.

This approach resulted in the facility receiving the 2009 Sustainability

Development Award from International Society of pharmaceutical

Engineering.

This Phase 2/3 clinical trial product facility is Pfizer’s first biotechnology

brown field development and the site was chosen for a variety of reasons,

including its proximity to the adjacent Pfizer Ringaskiddy site which allowed

the new facility to use spare capacity of the existing wastewater treatment

plant and fire main system rather than building a new treatment plant or

bringing in new tanks and pumps for fire water retention. Other outstanding

sustainability elements of this project included the re-use of 5,000 cube

meters of crushed rubble from an old adjacent facility for the new

substructure and 30,000 cubic meters of excavated material for general site

fill and landscaping; the use of an eco-seal, grey, insulated roof membrane to

reduce the heat island effect; and site orientation to optimize solar gain.

1.2 Facility Overview

1.2.1 Introduction

The Pfizer Monoclonal Antibodies (MAbs) facility was constructed at

Shanbally, Ringaskiddy, County Cork, for the manufacture of Phase II &

Phase III Drug Substance candidate therapies.

The clinical trial and initial product launch facility is designed to manufacture,

purify, formulate and bulk fill mammalian cell culture derived proteins. These

will form the Active Pharmaceutical Ingredient (API) in products intended for

human use. The facility includes two 2500 litre production bioreactors. In

addition, the facility includes a warehouse in which the raw material and

finished goods will be stored, Quality Control and Technical Services

Laboratories and Administration areas.

The facility operates on the site formerly occupied by the ADM (Archer

Daniels Midland) plant, which closed in 2006 and as part of the divestiture of

this site - ADM surrendered its IPC license. During this process an audit of the

site was conducted by the EPA to verify that all the required terms of the

decommissioning and demolition met the agreed DMP (Decommissioning

Management Plan) criteria and the license surrender was accepted on that

basis.

1.2.2 The Installation and Its Activities

1.2.2.1 Overview The facility comprises of a main building and a guard house. The main

building has five main areas:

• Production area,

• Warehouse,

• Laboratory/office area,

• Utility area (or Central Utility Plant),

• Plant mechanical area.

The production area is predominantly on the second floor of the three storey

central part of the building. The central utilities plant is be located on the

ground floor of the central block. The engineering support facilities are located

on the ground floor and lower mezzanine in the central block and also the

plant mechanical area is located on the top floor of the central block.

The warehouse is in the Western annex to the main building. The main

storage areas are located in the single storey annex with ancillary facilities

such as sampling, gowning and freezers on the ground floor of a two storey

section, with mechanical services on the first floor.

The laboratories & offices are located in the two-storey southern section of the

main building. The staff support facilities (i.e. canteen, locker rooms, hygiene

etc.) are located on the ground floor.

Some structures from the previous facility (ADM) have been retained through

the construction and commissioning phases of the project. The future

retention or otherwise of these structures is likely to be decided in 2010.

1.2.2.2 Production Area The production area processes include innoculum lab, cell culture, purification

and process support functions. Cell culture includes seed bioreactors,

production bioreactors, and recovery / harvest unit operations. Purification

includes buffer hold, purification, formulation and bulk fill. The Process

Support areas include the dispensary and parts wash, as well as media and

buffer preparation areas.

1.2.2.3 Warehouse Raw materials and finished goods are stored in the warehouse. Separate

Cold Rooms, Fridges and Freezers are provided for storage of raw material

and finished products. Secured access controlled Cell Bank storage is also

included in the warehouse.

A material sampling (Quality Control Inspection) area is provided in the

warehouse for material inspection and sampling. Separate dispensing areas

are provided for handling buffer and media solutions at large volumes. A kit

staging area is also provided.

Spare parts are stored predominantly in the engineering & maintenance

storage area.

Fork trucks, pallet trucks and drum handling equipment and lifts are utilised

for materials management. Predominantly the raw materials are received in

drums, subdivided into containment bags and charging canisters.

1.2.2.4 Laboratory/Office

The laboratories are situated on the second level of the

Laboratory/Administration area. These house the laboratory facilities for two

separate functions:

o Quality Control Laboratory

o Technical Services Laboratory.

Quality Control Laboratory

The Quality Control laboratory will carry out the following functions:

o Raw Material Testing

o In-Process Control Testing

o Final Drug Substance Testing

o Microbiological Testing

o Drug Product Testing

o Stability testing

The Quality Control Laboratory contains a range of analytical equipment to

enable the perquisite range of testing to be carried out on site. The separate

laboratories and support areas and their functions within Quality Control are

as follows:

o General Laboratory,

o Two Microbiology Laboratories,

o Stability Laboratory,

o Support rooms such as wash up area, sample receipt,

autoclave and steriliser room, chemical store, document store,

and meeting rooms. These are shared with Technical Services.

Technical Services Laboratory

The Technical Services Laboratory carries out the following functions:

o Process characterisation work on new products

o Process optimisation work

o Plant support

o Raw material use tests

o Process validation support

o Working cell Bank Storage

The Technical Services Laboratory is divided into Upstream and Downstream

Processing areas. The Upstream area uses wave reactors and laboratory

scale bioreactors to mimic the Upstream Plant processes. These are used for

process characterisation work, raw material evaluations, support of plant trials

and plant process investigations and process validation studies.

The Downstream area houses chromatography and filtration equipment to

mimic the Downstream Plant processes and is used for similar activities,

studies and investigations as the Upstream area.

The Quality Control and Technical Services Laboratories are fitted with

fumehoods, biosafety cabinets, refrigerators, freezers, incubators and are

supplied with high quality water, gases and other services / utilities for a fully

functioning laboratory.

1.2.2.5 Utility Area (or Central Utility Plant) The central utility plant (internal area) contains the Water-for-Injection

generation and storage, Reduced Ion Water generation and storage, clean

steam generation, biowaste inactivation, process waste water pre-treatment

(equalisation, neutralisation), plant steam boiler, heating ventilation and air

conditioning chillers, process chiller, the compressed air system, clean-in-

place systems and temperature control modules associated with the process

vessels.

Externally are located cooling towers and pumps, utility water tank and

pumps, bulk gas storage (carbon dioxide and oxygen), chemical treatment

systems, laboratory gases (bottles), emergency generator (with integral fuel

oil storage tank) and rotary uninterruptible power supply system (UPS).

1.2.2.6 Plant Mechanical Area The plant mechanical area holds the Air Handling Units (AHU’s) and HVAC

hot water system.

1.2.2.7 Guard House There is a guard house adjacent to the main gate, which is manned by

Security 24/7. All visitors, deliveries etc. to the facility are required to report to

the guard house on arrival.

1.2.2.8 Working Hours

Flexible work patterns are employed in the operation of the facility, which can

extend to 24 hour 7 day per week activity, depending on production

schedules.

1.2.2.9 Production Process The Pfizer MAbs Biotechnology Facility employs well characterised

genetically modified mammalian cell cultures in order to produce therapeutic

proteins. These well defined cell lines have a long history of over two decades

of safe use in large-scale production operations.

Cell Culture is designed according to Biosafety Level 1 - Large Scale (BL1-

LS) per the United States National Institute of Health (NIH) guidelines and

meets the requirements of Containment Level 2 (CL2) per European Union

Council Directive 98/81/EC (26 October 1998). The facility is currently

licensed for the contained use of Class 1 GMM’s, as per GMO Permit Number

G-0299-01.

The liquid biowaste from manufacturing is inactivated prior to being combined

with the process effluent waste. The combined waste streams are then pH

neutralised (pH 6-9) prior to discharging to the adjacent Pfizer Ringaskiddy

API plant for further treatment (aerobic).

Cell Culture The cell lines are stored in a cell bank from where the cells are transported to

the inoculation preparation laboratory located in the cell culture suite, and

thawed. The cells are then combined with appropriate media and put under

the necessary physical conditions for cell growth. The cells are passed

through a series of flasks and then into Wave Biotech cell culture bags

ranging in size from 250ml to 2L to 20L to 100L and finally transferred to a

500L seed bioreactor. The final cell culture stage is performed in a 2500L

production bioreactor. The production bioreactor is inoculated (with product

from the 500L seed bioreactor) and maintained at desired backpressure,

temperature, agitation, pH, and air flow/dissolved oxygen, generally for

approximately two week cell culture cycle. The raw cell culture broth is the

product of this operation, and contains media components, cell mass, host

cell protein and other by-products.

The bioreactors are cleaned between batches with dilute solutions of clean-in-

place materials. After cleaning each bioreactor in turn they are sterilised in

place with clean steam. The bioreactors are then ready to be filled with media

for the next cell culture operation.

All cell based operations are carried out in closed equipment and before any

cell containing equipment is opened, either chemical or thermal inactivation of

the cells is carried out to prevent operator contact or other release to the

general production area.

Cell Culture Harvest

The product is harvested from the raw cell culture broth by passing through a

centrifugation step, followed by several stages of filtration which remove cell

mass and produce a clarified harvest broth which contains the desired product

protein. For each batch, the filter system is thermally inactivated (with clean

steam) prior to change-out of the (containment) filter cartridges and the

system is cleaned between batches with clean-in-place solutions and rinsed

with water. After each clarification, the depth filter cartridges are inactivated

and disposed of as solid waste.

.

Purification Operations The purification process takes the clarified harvest broth and passes it

through viral inactivation, chromatography purification steps, ultrafiltration and

viral removal to remove unwanted components and produce the final product

to the required specification.

Final Fill and Bulk freezing

Formulation solution is then added to the concentrated product. The bulk-

purified, formulated protein is filled into bags, and frozen and stored at

-40 degrees Celsius.

The bulk product is then sent to a sister Pfizer Aseptic Production Plant for

formulation into the final product.

Waste Management

Liquid waste which could potentially contain genetically modified micro-

organisms material will, depending on the quantities, either be routed to the

biological waste heat inactivation system or to the decontamination

autoclaves.

All solid material which could potentially be contaminated with genetically

modified micro-organisms will be either chemically or thermally pre-treated

on-site to ensure deactivation prior to disposal as non-hazardous waste off-

site, or sealed in double bags and placed in biowaste sealed containers and

sent for disposal by incineration.

1.2.2.10 Plant utilities The following plant utilities are in place:

o Potable Water,

o Domestic Water,

o Compressed Air Generation,

o Process and Instrument Air,

o Process Chilled Glycol,

o HVAC Chilled Water,

o HVAC Heating Hot Water,

o Cooling Tower Water,

o Plant Steam and Condensate,

o Natural Gas.

o Clean utilities in the facility will include:

o Reduced Ion Water (RIW),

o Water-for-Injection (WFI),

o Clean Steam (CS),

o Clean Condensate,

o Clean Air,

o Clean-in-Place (CIP),

o Oxygen,

o Carbon Dioxide,

o Liquid Nitrogen.

1.2 Facility Environment Health & Safety Statement

1.3 Organisational Chart for Environmental Management

, Site Leader

Engineering & EHS

Team Leader

Finance/Supply Chain

Team Leader

RFT Team Leader Tech. Serv. Team Leader

HR Team Leader

Maintenance/ Utility Lead

EHS Lead PAT Specialist

Purification Scientists

Purification Team Lead

Cell Culture Scientists

Cell Culture Team Lead

Process Validation Specialist

RFT Facilitator Business Analysts

Buyer/Planners

Team Development

Facilitator

General Administration

Quality Team Leader

QC Team Lead

Bio-Analysts

Change Control/ Deviations Spec.

Regulatory Specialist

QO Administration

GMP Trainer QC Specialist

Production Support Personnel

QC Systems Support Specialist

Validation Specialists

Micro-Analyst & Water Sampler x 6

PDOCS Support/ Documentations

Production Team Leader

Biotechnicians

Process Engineers

Purification Lead

Cell Culture Lead

Production Administration

Reliability Engineer

EHS Specialists

Reliability Support Eng’s

ENG/ EHS Administration

Planner/ Scheduler

C&M Engineer

Data Build EAMS

& Calibration Techs

IFM

Tech. Services Support Staff

1.4 Water Emissions Monitoring Data

1.4.1 EMISSIONS TO SEWER

Emissions to Sewer Overview:

A key element of the sustainable design of the utilities network for the facility

was to utilise capacity in the adjacent Pfizer Ringaskiddy (API) Plant. This has

resulted in significant savings in terms of construction and ongoing energy

utilization.

The IPPC license stipulates that a maximum of 240m³ of process waste water

may be transferred daily to the Ringaskiddy facility with a maximum daily

loading of 1000kg of COD.

Table 1.4

Parameter Mean

(Daily)

Limit

(Daily)

Emission

(per Annum)

Flow (m³) 131.5 240 24,862

COD (kg) 51.4 1000 9,714

N (kg) 1.22 n/a 229

P (kg) 1.56 n/a 295

BOD (kg/Day) 25.8 n/a 4,868

It is readily evident from the above flow and COD data that the process norms

are within the permissible levels as defined in the IPPC license.

Warning and action levels have been established for the emission limit values

as per IPPC License, so as to ensure that the forward feeding of process

waste water ceases prior to any Emission Limit value being approached and

that the Wastewater Treatment System goes into a recirculation mode, with

correction in the case of pH, COD or flow, or an engineering response in the

case of instrumentation & equipment issues.

1.4.2 EMISSIONS TO SURFACE WATERS

Interpretation of Surface Water Data

Continuous monitoring of discharges to Surface Waters is provided by the

online TOC & pH analysers, located at the outfall analysing station. This data,

along with the daily visual inspections, indicates that there was no

contamination of surface water during the AER reporting period and no

diversions due to pH or TOC excursions to the facility firewater diversion

collection tank occurred.

1.5 Air Emissions Monitoring Data

IPPC License P0862-01 places no specific air monitoring requirements on the

facility at this time and hence has no air emissions monitoring data was

generated for this reporting period.

1.6 IPPC Licence Compliance

There were no exceedances of any of the prescribed emission limit values

during the reporting period. The site had established both warning and action

limits around its discharge parameters, and this has ensured compliance.

During the annual inspection which took place September 23rd 2009, no non

compliances were noted and any observations noted, were actioned and

closed out.

1.7 Noise Survey

SITE BOUNDARY LOCATIONS

Night-Time Measurements

The night-time LAeq noise levels ranged from a high of 45.9dB(A) at B1 to low

of 41.1dB(A) at B2. The main contributing noise sources at each boundary

were frequent to intermittent traffic with steady and continuous plant noise.

No onsite tones were detected.

Daytime Measurements

The elevated daytime LAeq levels when compared to the night-time

measurements can be attributed to increased traffic levels on the Ringaskiddy

Road. No tones were detected during the daytime survey.

The noise limits as specified in the IPPC licence were not exceeded by any

noise sources on-site at the Pfizer Biotechnology facility. Exceedances were

associated with external noise sources and as such are not subject to the

conditions of the IPPC licence.

NOISE SENSITIVE LOCATIONS

Night-Time Measurement

A low level background sound from the Pfizer facility was audible at locations

NSL2, NSL3, NSL5 and NSL6 during the night-time measurements. The

Pfizer facility was not audible at NSL1, NSL4 and NSL7. While NSL2, NSL3

and NSL6 were above the night-time noise limit of 45dB(A), the elevated

noise levels were attributed to traffic and not derived from an industrial source.

Where road traffic is considered a dominant noise source, examining

background noise levels (LA90) can display more indicative noise levels of the

ambient environment. In this case all LA90 results from night-time

measurements were below 45dB (A).

Daytime Measurement

During the daytime surveys, traffic (private and commercial) and other typical

urban activities including use of a chainsaw, barking dogs, birdsong, aircraft

and harbour movements contributed significantly to the noise level at each

location. In the majority of cases plant noise was inaudible. Plant noise was

only audible for brief periods at NSL6.

A single tone (100Hz) was recognised at NSL6, but can be attributed to a

tugboat, which was passing down river during the survey and was noted as a

significant source of noise for a period of approximately 5 minutes during the

survey at this location.

Location

Reference Description

B1 Southern Site Boundary

B2 Western Site Boundary

NSL 1 Port of Cork/Deep Water Berth Entrance – within 20m of

residential homes

NSL 2 Shanbally Church car park – centre of Shanbally village

NSL 3 Residential property overlooking Pfizer Golf Course

NSL 4 Residential properties at Ballyfouloo

NSL 5 Residential properties at Monkstown Rise

NSL 6 Monkstown Road - Residential property “Corr Iasc”

NSL 7 Monkstown Demesne – residential properties

Measurement Time

Measurement Duration

LAeq LAeq LAmin LA10 LA90

04.59 30 mins 36.3 60.9 31.4 37.6 33.8

18.14 30 mins 45.0 64.5 37.0 46.6 39.6

The LAeq, 30 min daytime value recorded at AN5 and AN6; the potential

noise sensitive receptors in accordance with licence conditions. The daytime

and night time noise levels recorded at AN1, AN2, AN3 and AN4 are similar

and in some cases better than those recorded during the 2007 survey. The

facility is located close to the heavily travelled N28 and the background traffic

noise levels are a significant contributor to overall noise levels.

CONCLUSION

Day and night-time noise monitoring was carried out in accordance with IPPC

Licence P0864-01. While levels in excess of the IPPC license limit values

were measured during the course of the surveys at noise sensitive locations

NSL 1 – 6 it is the conclusion of this report that these levels are neither

attributable to, nor representative of the noise contribution of the Pfizer

Biotechnology site, to the local noise climate.

The background noise levels (LA90) are more representative of the contribution

of Pfizer Biotechnology facility to the noise environment. While the Pfizer

Biotechnology site is audible on occasion during lulls in traffic, it does not

impose on the noise environment to a significant extent nor does it dominate

the character of the noise environment in the area.

A tonal noise component was not denoted at any of the boundary locations

(B1-B2).

It is the conclusion of this assessment that the operation of the Pfizer

Biotechnology Plant does not contribute to elevated noise levels at noise

sensitive locations surrounding the site. Furthermore, the plant does not

contribute to tonal or impulsive components at these locations.

1.8 Waste Arisings: 1.8.1 Annual waste arising for 2009 is summarized in the attached Tables. Records for hazardous waste shipments sent off-site

including waste contractor documentation. C1 Consignment forms are held on site and are available for viewing.

Waste Description

EWC Code

Quantity MT/year

Haulier/ Broker Further Treatment(Method, Location & Undertaker)

Recovery, reuse or recycling (Method, Location &Undertaker)

Final Disposal (Method, Location & Undertaker)

Medical/ Sharps/ Bio Hazardous Waste

18 01 03*

0.01

SRCL W0054-02

n/a

n/a

SRCL W0054-02 [D9] 520 Beech Rd Western Ind. Est. Dublin 12, Ireland W0054-02

Empty Containers 15 01 10* 2.286 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

n/a

Sava,A 51 G00 508 [D10] A 51 V00605 [R1] ,Osterwete 1,.,Brunsbuttel,D- 25541,Germany

Chemically Contaminated Process Waste. Sodium Hydroxide

07 05 13* 7.354 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

n/a


Chemically Contaminated Process Waste. Isopropyl Alcohol


n/a

n/a


Antifoam, Oils 07 05 04* 0.275 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

n/a


Waste Description

EWC Code

Quantity MT/year


Recovery, reuse or recycling (Method, Location & Undertaker)


Solvents, Oils 07 05 04* 1.106 Veolia Environmental Services Technical Solutions

n/a

Veolia ES Tech. Solutions, W0050-02 [R13]Corrin, Fermoy, Cork, Ireland

Corrosive Solids Sodium Hydroxide,


n/a n/a Sava,A 51 G00 508 [D10] A 51 V00605 [R1] ,Osterwete 1,.,Brunsbuttel,D- 25541,Germany

Waste/Spent Sanitization Agents


n/a

n/a


Corrosive Waste – Acidic Sulphuric and Acetic Acid


n/a

n/a


Inks & Toner 08 03 18 0.294 Veolia ES Technical Solutions, W0050-02 Corrin, Fermoy, Cork, Ireland

n/a

Source Imaging [R13] WP 124/06. Unit 2 Banagher Enterprise Centre, Offaly

Waste Description

EWC Code

Quantity MT/year




Waste Electrical Electronic Equipment (WEEE)

16 02 13* 0.2 KMK W0113/03 n/a KMK,W0113-03, [R4]Cappincur Industrial Estate ,Daingean Road, Tullamore, Offaly ,Ireland]

Waste Description

EWC Code Quantity MT/year

Haulier/ Broker Further Treatment (Method, Location & Undertaker)



Paper & Cardboard

20 01 01 5.91

Veolia Environmental Services W0173-01 Forge Hill, Cork

n/a

R13 Veolia Environmental Services W0173-01.Forge Hill, Cork [R13]

General Waste 20 03 01 131.3 Veolia Environmental Services W0173-01 Forge Hill, Cork

n/a n/a East Galway Landfill, Galway. [D1] W0178-01

Timber 20 01 38 20.58 Veolia Environmental Services W0173-01 Forge Hill, Cork

n/a Veolia Environmental Services W0173-01.Forge Hill, Cork [R13]

Metal 17 04 05 14.38 Cork Metal WCP LK -08-589-01

n/a Cork Metal, Dublin Hill Cork WCP LK -08-589-01 [R4]

Glass 20 01 02 3.83 Rehab Recycling 08/04 Reg.WMC.146/03

n/a Rehab Recycling Partnership [R13] Monaghan Rd. Cork

Waste Description

EWC Code Quantity MT/year

Haulier/ Broker

Further Treatment (Method, Location & Undertaker)



Plastic Packaging and containers

20 01 39 2.96

Veolia Environmental Services W0173-01 Forge Hill, Cork

Veolia Environmental Services W0173-01.Forge Hill, Cork [R13]

Process waste water

16 10 02 26,223 n/a Pfizer Ringaskiddy API IPPC License P0013-04 [D8]

Pfizer Ringaskiddy API IPPC License P0013-04 [D7]


16 02 14 0.276 KMK W0113-03

KMK,W0113-03, [R4]Cappincur Industrial Estate ,Daingean Road, Tullamore, Offaly ,Ireland


16 02 16 0.02 KMK W0113-03

KMK,W0113-03, [R4]Cappincur Industrial Estate ,Daingean Road, Tullamore, Offaly ,Ireland

1.9 Resource Utilisation 1.9.1 Resource Utilization Summary:

The resource summary below details the quantities of Electricity, Natural Gas and

water that the facility consumed during 2009. During much of this period the facility

was under construction and in the process of non routine commissioning activities, so

these figures cannot be considered as indicative of those that would be consumed

during routine manufacturing.

Resource Utilization Units

Electricity 5539.6 MW hr

Natural Gas 4936.7 MW hr

Water 44,382 M³

Substantial resources and technology were applied to the design and installation of

the Utility infrastructure for the site and this was key to the sustainability award

received by the site.

Towards the end of 2009 baseline data emerged as the construction and

commissioning activities waned. Indeed the gas and electricity usage for year came in

at only 90% of the projected figure.

It is planned that under the auspices of the onsite cross functional Energy Team that

further significant inroads will be made in resource utilisation, not just on electricity and

gas, but also water and raw materials.

The graphic below extracted from the Energy audit (attached) indicates the detailed

information available so that targeted responses can be made in order to apply

maximum effort in the areas where it will bring most benefit

See below graphs for baseline data:

1.9.1 Electrical Load Split

Electrical Load Split

Utilities HvacProcessFreezersElevatorWarehouse220 v LoadsLightingLab 380V

1.9.2 Gas usage Load Split

Hot wat er

Cell Cult ure

Recovery

Media Prep

DS1 Purif icat ion

DS2 Purif icat ion

Buf f er Preperat ion

CIP syst em 1

CIP syst em 2

Glass Washers

Aut oClaves

WFI loop heat er

Lab Aut oclave

Bio inact ivat ion

Header Maint enace Traps

WFI syst em

Clean St eam Syst em

8.6 bar t rap syst em

1.9.3Water Usage

RIW GenerationPotable waterBoilerCooling towerBlowdown coolerSewer Pallet washerWarehouse samplingGMP autoclaveDecontam AutoclaveLab Vac system

The key water users on site have also been identified and a targeted reduction

programme is underway, which will run through 2010. See Targets and Objectives.

1.10 Environmental Incidents and Complaints No complaints were received as a result of the onsite activities during this reporting

period.

An event took place on July 25th, which involved the loss of a single (non hazardous)

general refuse sack, which contained paper towels, from our dedicated waste

contractors vehicle in the vicinity of Rafeen Cross (on the N28). As soon as the site

was notified of this, site personnel were dispatched to retrieve the non hazardous

refuse sack for proper disposal.

The Agency was informed on the day of the discovery of this occurrence

Corrective actions were implemented with the Contractor involved in order to ensure

there was no reoccurrence.

1.11 GMM (GENETIC MODIFIED MICROORGANISM) EPA CONSENT

The facility was granted a First time Contained Use Permit for the use of Class 1 GMM

in October 2008 (G0299-01). The necessary control systems have been put in place in

order to comply with all requirements of this permit.

2. Management of the Activity 2.1 Introduction An environmental management plan has been established for the site in accordance

with the IPPC license and this is based on the ISO 14001 standard.

2.2 Status Report on Schedule of Objectives and Targets (June – December 2009) Pfizer Shanbally Environmental Management Programme December 2009 (Incorporating targets and objectives) Aspect No. 1: Emissions to Surface Waters Objective Target Action Status

1.1

Set Action and Warning limits for TOC and pH on Surface water Discharge

1. Collate for 6 Months. 2. Complete statistical

analysis 3. Submit proposed Action

and Warning levels to Agency for approval.

4. Once Limits are approved update control parameters on Surface Water SCADA Control System

5. Update Standard Operating procedure EHS-10-3026

For approval Pending agreement with Agency

Optimising surface water discharge controls

1.2

Complete an ERT (Emergency Response Team) drill involving a scenario where there is a release to surface water

1. Define the drill scenario and schedule the group to action the drill. 2. Monitor the response of the ERT personnel. 3. Optimise process based on outcome of drill (i.e. Update ERT training and/or procedures as necessary)

Complete

Aspect No. 2: Emissions to Process Sewer/Waste Water Objective Target Action Status

2.1

Determine baseline for Process effluent during normal operations.

1. Collate and trend weekly and Monthly analytical data.

Complete Quantify Process Wastewater Baseline data and Assess changes/ abnormal events

2.2

Develop system for tracking and Monitoring Waste Discharges.

1. Production operations to report non routine (e.g. ‘Buffer hold’) discharges to Engineering-EHS 2. Put formal system in place to manage & approve non-routine discharges

Ongoing --

Q2 2010

Aspect No. 3: Noise Emissions Objective Target Action Status

3.1

Determine boundary noise 1. Select suitable monitoring locations.

2. Seek Agency approval

Proposal Submitted

Complete Establish Baseline Noise data for site boundary 3.2

Conduct Noise Survey Execute noise survey in accordance with requirements

Monitoring complete Complete

Aspect No. 6: Hazardous waste generation and Disposal Objective Target Action Status 6 (a) Hazardous Waste Control

6.1

Optimise waste segregation practices on-site

2. Implement internal waste auditing programme

Ongoing Q2 2010

6.2

Ensure that only audited waste contractors are engaged for Waste Management activities

1 Review facilities engaged versus approved database.

Complete

6 (b)Hazardous waste reduction Programme

6.3 Review hazardous waste classifications (secondary contaminated) in order to ensure non-hazardous waste fractions can be excluded from hazardous classification.

1. Conduct classification for the following waste streams: - o Cleaning Materials o Secondary Contaminated Chemical Waste from Production (Media Prep, Buffer Prep, Purification, Cell Culture), And Warehouse 2. Revise SOPs for any revisions to classifications for operations personnel

Ongoing Q2 2010

6.4 Generate hazardous waste quantitative baseline

1. Collate and trend all hazardous waste types and quantities

Ongoing Q2 2010

6.5 Assess opportunities to reduce, reuse and recycle

1. Implement reduction measures in line with Objective 6.2 and 6.4. 2. Use baseline obtained in Objective 6.4 to set quantifiable targets

Ongoing Q2 2010

Aspect No. 7: Non Hazardous waste Generation Recovery/Disposal Objective Target Action Status

7.1

Optimise non-hazardous waste segregation

1. Install baler for cardboard and plastics

Complete

7.2

Optimise non-hazardous waste segregation

2. Optimise design of non-hazardous waste handling area to improve logistics and segregation on-site

Ongoing: 5S system being applied to the Waste management Area

Q3 2009

7.3 Generate non-hazardous waste quantitative baseline

1. Collate and trend all nonhazardous waste types and quantities.

Compete


1. Use baseline obtained in Objective 7.3 to set quantifiable Targets

Ongoing

Q1 2010

Non-Hazardous Waste Reduction Programme 7.5

Establish Site recycling team

Nominate Team members Incorporated into Energy Team - Complete

Aspect No. 8: Water Usage and Conservation Objective Target Action Status

8.1

Verify water flow meters and totalisers

1. Calibrate Flow meters. Complete

8.2

Generate Site wide map of water usage and discharge

1.Map Process Water distribution points and downstream user points within buildings (i.e. RIW and WFI) 2. Collate all information from water usage data gathering and build within overall site map.

Ongoing Q2 2010

Water Conservation and use Reduction

8.3 Achieve full optimisation of water usage across the site

1. Optimise Utility RIW regeneration rates

Ongoing Q4 2010

8.4 Evaluate water re-use projects

1. Investigate RIW Reuse opportunity – e.g. cooling Tower make up. 2. Implement opportunities for reuse as highlighted by the Site water use map

Ongoing Q4 2010

Aspect No. 10: Raw Materials Objective Target Action Status Identification of Reduction Fugitive Emissions

10.1

The majority of Raw materials are high value. The facility is designed around the principles of Lean Manufacturing and as such minimises all waste from the process. Therefore at this time it is deemed that there is little scope for optimisation.

n/a

Aspect No. 11: Energy Objective Target Action Status

10.1

Create energy policy for the Site

1. Write energy policy for the Site 2. Get approval from the SST

Complete

10.2

Implement Site Energy Team

1. Establish a Site Wide energy team with representation from engineering, operations and purchasing 2. Establish project charter and team goals

Complete Complete

10.3

Complete Energy Audit

1. Determine the nature and extent of the Energy Audit 2. Complete the audit

Complete

10.4

Review design and energy efficiency

1. Review energy design intent of major utility systems and energy efficient design features. 2. Review actual performance of energy efficient design and major utility systems

Ongoing

Q2 2010-

10.5

Record and measure energy usage

1. Set up a system to enable natural gas and electricity usage to be trended. 2. Trend usage and profile significant energy users.

Ongoing

Q3 2010-

10.6

Initiate Energy Awareness Programme

1. Site Energy Team to develop an energy awareness programme so that the Site personnel take ownership.

Ongoing: Poster campaign in place. Energy Awareness Day Organised for Q2.

Q2 2010-

Energy Use Reduction and Efficiency

10.7

Energy Reduction and Efficiency.

1. Identify key targets to be achieved over the next 3 years.

Ongoing Q2 2012

2.3 Environmental Management Plan 2010 1.0 To Improve environmental management on site Objective No Target Plan Responsibility Status 1.1 Training and Awareness 1. Develop and roll our

further environmental awareness programme

EHS Specialist Q3 2010

1.2 ISO 14001:2004 Certification 1. Further align EHS management systems with standard requirements. 2. Evaluate time line & future plan for site certification

EHS Lead Q4 2010

2.0 To reduce waste generation on site

Objective No Target Plan Responsibility Status 2.1 Optimise non-hazardous waste

segregation 1. Optimise design of non-hazardous waste handling area to improve logistics and segregation on-site

Ongoing: 5S system being applied to the Waste Management Area

Q3 2009

2.2

Assess opportunities to reduce, reuse and recycle.

1. Use baseline obtained in Quantifiable Targets

Ongoing – working with TWM vendor to progress identified opportunities

Q3 2010

3.0 To reduce water consumption Objective No Target Plan Responsibility Status 3.1 Generate Site wide map of

water usage and discharge 1. Map Process Water distribution points and downstream user points within buildings (i.e. RIW and WFI) 2. Collate all information from water usage data gathered and build within overall site map.

Energy Team/ Energy Lead

Development underway.

Implement waster use reduction based on findings of 3.1

1. Optimise CIP water usage on key vessels


Ongoing, potential reductions identified

Evaluate water re-use projects 1. Investigate RIW Reuse opportunity – e.g. cooling Tower make up. 2. Implement opportunities for reuse as highlighted by the Site water use map


Q4 2010

4.0 To increase waste recovery and recycling: Objective No Target Plan Responsibility Status 4.1 Optimise waste segregation

practices on-site 1. Implement internal waste auditing programme

EHS Specialist Ongoing

4.2 Review hazardous waste classifications (secondary contaminated) in order to ensure non-hazardous waste elements are be excluded from hazardous streams.

1. Conduct classification for the following waste streams: - o Cleaning Materials o Secondary Contaminated Chemical Waste from Production (Media Prep, Buffer Prep, Purification, Cell Culture), and Warehouse 2. Revise SOPs (Standard Operating procedures) as necessary


4.3 Generate hazardous waste quantitative baseline

1. Collate and trend all hazardous waste types and quantities



1. Implement reduction measures in line with Objective 4.1 and 4.2 2. Use baseline obtained in Objective 4.3 to set quantifiable targets


5.0 To improve energy and utility efficiency Objective No Target Plan Responsibility Status 5.1 Review design and

energy efficiency

1. Review energy design intent of major utility systems and energy efficient design features. 2. Review actual performance of energy efficient design and major utility systems.

Energy Team/ Energy lead

Q3 2010-

5.2 Record and measure energy usage

1. Set up a system to enable natural gas and electricity usage to be trended. 2. Trend usage and profile significant energy users

Energy Lead Ongoing. Improved software being purchased to assist Q3 2010

5.3 Initiate Energy Awareness Programme

1 Organise Energy Awareness day 2. Site Energy Team to develop an energy awareness programme so that the Site personnel take ownership


Scheduled April 2010

5.4 Energy Reduction and Efficiency.

1. Identify key targets to be achieved over the next 3 years


Q4 2012

5.5 Establish Carbon Footprint for Site 1. Develop system for site to establish carbon footprint


Q4 2010

3. Pollution Release and Transfer Register (PRTR)

The Pollution Release and Transfer Register for the facility has been uploaded

electronically to the Electronic reporting workbook and a copy is attached at

the end of this report. (See attachment 8)

4. Bund Integrity Assessment Report

All structures required to retain liquid from spills leaks etc., were tested as part

of the facility construction and commissioning. These structures are divided

into three categories:

i) Commercially sourced structures (e.g. Chemstores) that were supplied

with test certificates and that were visually inspected upon arrival and

installation.

ii) Structures that are required to retain water, e.g. Firewater Retention

Tank and Stormwater discharge monitoring point, and

iii) Bunds surrounding tanks and vessels.

The Test Certificates for ii) and iii) above are attached in Attachment 4

5. Pipeline Testing and Inspection

The specified pipelines required were tested as part of the facility construction

and commissioning, and passed the required standard.

The Test packs for the above are attached in Attachment 5

6. Environmental liabilities and Residual Management

Pfizer Global Environmental, Health and Safety have established procedures in

relation to Acquisition and Divesture of Real Property. These procedures will

apply at the Pfizer MAbs SSF site. Pfizer Biotechnology Ireland’s responsibility

is to ensure that any business divesture involving real property is preceded by

an environmental due-diligence investigation to assess and quantify potential

environmental liabilities associated with the transaction.

This Environmental Liability Risk Assessment (ELRA) for the Pfizer

Monoclonal Antibodies (MAbs) Facility constructed at Shanbally, Ringaskiddy,

Co. Cork has been undertaken in accordance with the methodology outlined in

the EPA Guidance Document.

Environmental risks associated with the operation of the plant were identified

with reference to the Environmental Impact Statement for the facility and

Process Hazard Reviews carried out for the plant. Likelihood and severity

factors were assigned to the risks in order to determine the extent of the

potential liability from unplanned events impacting on the environment.

Please reference attached Environmental Liabilities Risk Assessment report

attached in Attachment 6.

In general, the risk associated with abnormal activities on-site is considered to

be acceptable and therefore the environmental liability costs would be covered

by Pfizer’s public liability insurance

This Decommissioning Management Plan (DMP) has been prepared to

comply with Condition 10 of Pfizer Biotechnology Ireland’s IPPC licence –

P0894-01. In particular, the Plan has been developed to satisfy the following

sub-clauses - 10.2 and 10.3 of Condition 10.

In accordance with the EPA Guidance on Environmental Liability Risk

Assessment, Residuals Management Plans and Financial Provision (EPA

2006), the risk classification tool was used, and the Screening and Operational

Risk Assessment is included as Attachment 7 to this report. The Assessment

found that the site has a risk category of 2, and therefore a residuals

management plan is not required.

8. Licence Specific Report Attachment 1 – Environmental, Health and Safety Policy

Attachment 2 - Energy Management audit

Attachment 3 – Site Noise Survey

Attachment 4 – Pipeline Test Report

Attachment 5 - Bund Integrity Report

Attachment 6 – ELRA: Environmental Liabilities Risk Assessment

Attachment 7 – DMP: Decommissioning Management Plan

Attachment 8 – PRTR: Pollution Release and Transfer Register

Attachment I – Shanbally Environmental, Health & Safety Policy

Attachment II - Energy Management Audit

Site wide Energy Audit Report June 2009

Rev 1.0

Pfizer Shanbally

Ringaskiddy

Cork

DOCUMENT CONTROL SHEET

Client Pfizer Shanbally, Ringaskiddy, Cork.

Project Title Energy Audit

Document Title Energy Audit Report

Document No. EA9025

DCS TOC Text List of

Tables

List of

Figures

No. of

Appendices

This Document

Comprises of the

following pages1 1 14 - - -

Rev

. Status Author(s) Reviewed By Approved

By Office of Origin Issue

Date 1.0 Issued for

Comment

John

McCarthyRM RM Curraheen, Cork 24/06/200

9

Confidentiality statement:

The information disclosed in this report should be treated as being strictly private and

confidential and you are requested to take all reasonable precautions to maintain its status as

such. You are requested to use and apply the information solely for the purpose of evaluating

this report and are asked not at any time to disclose or otherwise make available the

information to any third party except for those officers, employees and professional advisers

who are required by you in the course of such evaluation to receive and consider the

information and who agree to be bound by these non-disclosure terms.

Executive Summary

This report is based on the findings of an energy review carried out onsite at Pfizer Shanbally,

Ringaskiddy, Cork.

Energy consumption at the site was analysed and Table 1 estimates the energy consumption

and associated costs for Shanbally’s operations for 20091.

Usage Cost Energy

kWh % € %

Electricity 6,087,886 44.6% €608,789 60.9%

Natural Gas 7,563,935 55.4% €302,557 30.3%

Water [m3] 95,134 N/A €87,523 8.8%

Total 13,651,821 100% €998,869 100%

Table 1: The estimated Shanbally annual energy consumption and associated costs for 2009.

As the facility becomes fully operational it is recommended to implement of Energy

Performance Indicators (EPI’s) to monitor the ongoing use of energy onsite. These can be a

beneficial tool in identifying periods of energy underperformance and will enable the early

identification of inefficient operation thus increasing productivity and reducing waste.

It is also recommended that a formalised energy management system, implemented in

conjunction with ISO:14001, would aid the Shanbally facility by ensuring that energy

intensive operations are proceduralised and hence operated in a consistent and energy

efficient manner. This would ensure the sustainability of the energy conscious work ethos that

is currently in place within the Shanbally site.

The site is currently not fully operational and therefore the normal operational conditions have

not been established. It is recommended to review part load operation of the utilities once

normal operation has been established. This may highlight inefficiencies due to part load

operation of equipment and utility services.

1 Figures are based on the budgeted consumption of electricity and gas for 2009 as the facility is not yet fully operational.

Table of Contents

EXECUTIVE SUMMARY............................................................................................. 50

1 INTRODUCTION................................................................................................... 52

2 ENERGY USE PROFILES.................................................................................... 53

2.1 Electrical Energy Usage .................................................................................... 53

2.2 Thermal Energy Usage...................................................................................... 56

2.3 Water Usage ...................................................................................................... 57

3 ENERGY MANAGEMENT................................................................................... 59

4 OPPORTUNITIES FOR ENERGY SAVING...................................................... 62

4.1 Recent/Existing Energy Saving Initiatives........................................................ 62

4.2 Suggested Opportunities for Energy Savings.................................................... 63

1 Introduction

The purpose of this energy review is to identify opportunities to improve the energy

consumption of the Pfizer Shanbally plant in Ringaskiddy, Cork. Shanbally is a newly opened

biologic facility which aims to be fully operational by the end of 2009.

The facility is a key component in realising Pfizer’s ambition to become a global leader in the

Biotherapeutics space. It is hoped the Shanbally site will become a centre-of-excellence for

process development and will incorporate the small scale production of products for phase 2

and 3 clinical trials.

The plant is conscious of the rising cost of energy and as such aims to minimise the quantity

of energy consumed and hence mitigate the associated costs. Shanbally is also conscious of

the environmental impact that their operation has and aims to curtail their CO2 emissions

hence limiting the plants’ carbon footprint.

2 Energy Use Profiles

The budgeted annual energy and water consumption and costs for the facility in 2009 are

detailed in Table 2. These figures were obtained from the energy tracking spreadsheet which

outlines the energy usage on a monthly basis with the budgeted energy consumption

compared to the actual amount invoiced from the energy suppliers.

Usage Cost Energy

kWh % € %

Electricity 6,087,886 44.6% €608,789 60.9%

Natural Gas 7,563,935 55.4% €302,557 30.3%

Water [m3] 95,134 N/A €87,523 8.8%

Total 13,651,821 100% €998,869 100%

Table 2: Estimated energy consumption for the Shanbally facility in 2009.

Site Energy Consumption

Electricity44.6%

Natural Gas55.4%

Site Energy Cost

Electricity60.9%

Natural Gas30.3%

Water [m3]8.8%

Figure 1: The estimated Shanbally annual energy consumption and associated costs for 2009.

2.1 Electrical Energy Usage

As this is a new facility that is not yet fully operational it is not possible to get a clear picture

of the electricity consumption profile for the site. Figure 2 details the electrical energy

consumption profile for the year to date along with the budgeted consumption. This graph

should be updated monthly to ensure the consumption of electricity is monitored and as the

facility becomes fully operational and more data is available an Energy Performance Indicator

(EPI) should be developed for the site total electrical consumption.

Site Total Electricity Consumption

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09

Elec

tric

ity C

onsu

mpt

ion

[kw

h]

Budget Consumption [kWh]Actual Consumption [kWh]

Figure 2: Site electricity consumption.

Figure 3 illustrates the breakdown of site total gas electricity consumption by user. This

breakdown is based on estimates which incorporates all the electrical energy users within the

facility including HVAC motive power, process equipment, lighting systems, etc. The rating

of the units and their anticipated usage was assessed in order to produce the breakdown. This

should be re-examined when more detailed electrical energy consumption data is available

and the site is fully operational.

At present it is estimated the electricity consumption breakdown for the facility is as follows:

• Utilities - 44.3%

• HVAC - 19.6%

• Process Equipment - 12.8%

• Misc. 380V Users - 8.4%

• Freezers - 7.6%

• Lighting - 4.8%

There are also a number of other small users including: Misc. 380V Users; the elevator and

the warehouse. In the future EPI’s should be developed for the significant electrical energy

users within the site as more data becomes available and the facility becomes fully

operational.

Site Electricity Consumption Breakdown by User

Utilities 44.3%

Hvac19.6%

Process12.8%

Freezers7.6%

Elevator1.0%

Warehouse0.4% Misc. 220V

8.4%

Lighting4.8%

Misc. 380V1.0%

Figure 3: Site electricity consumption breakdown by users.

2.2 Thermal Energy Usage

As is the case with the electrical energy this is a new facility and so only 5 months of gas

consumption data is available. Figure 4 details the gas consumption profile for the year to date

along with the budgeted consumption. Similarly to the electricity consumption an EPI should

be developed for the site total gas consumption as more data becomes available and the

facility becomes fully operational.

Site Total Gas Consumption

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000


Gas

Con

sum

ptio

n [k

Wh]

Budget Consumption [kWh]Actual Consumption [kWh]

Figure 4: Site gas consumption.

Figure 5 illustrates the breakdown of site total gas consumption by user. This breakdown is

based on estimates which incorporate the rating of the associated units and their anticipated

demand. This breakdown should be re-assessed when more detailed gas consumption data is

available and the site is fully operational.

At present it is estimated the gas consumption breakdown for the facility is as follows:

• Hot Water Boiler - 55.0%

• Steam Boiler - 35.2%

• Kitchen - 9.8%

In the future EPI’s should be developed for the significant gas users within the site as more

data becomes available and the facility becomes fully operational.

Site Gas Consumption Breakdown by User

Hot water Boiler55.0%

Steam Boiler35.2%

Kitchen 9.8%

Figure 5: Site gas consumption breakdown by users.

2.3 Water Usage

A water meter was not installed. Shanbally are being billed for the difference between the

council meter to the tower & what API use from the tower

Site Water Consumption

-

2,000

4,000

6,000

8,000

10,000

12,000

14,000


Wat

er C

onsu

mpt

ion

[m3]

Budget Consumption [m3]Actual Consumption [m3]

Figure 6: Site Water Consumption.

Figure 7 illustrates the breakdown of site water consumption by user. This breakdown is

based on the estimated water usage of various pieces of equipment. It should be noted that a

water meter was not installed at the main incomer for the Shanbally facility. The Shanbally

facility and receives its water from the same tower as the adjacent Pfizer Ringaskiddy API.

The Shanbally bill is based on the difference between the council meter to the water tower

and the usage at the Pfizer API plant. It is recommended that site install its own water meter

to ensure it is not being billed for leakages and usage that occurs outside of the facilities

control.

At present it is estimated the water consumption breakdown for the facility is as follows:

• RIW Generation - 28.0%

• GMP Autoclave - 22.1%

• Cooling Tower - 15.8%

• Pallet Washer - 9.2%

• Warehouse Sampling - 5.5%

• Decontamination Autoclave - 5.5%

There are also a number of other small users including: Lab Vac system; potable water;

boiler; blow down cooler and sewer.

Site Water Consumption Breakdown by User

RIW Generation28.0%

Potable water2.6%

Cooling tower15.8%Blowdown cooler

2.9%Sewer 2.4%

Pallet washer9.2%

Warehouse sampling5.5%

GMP autoclave22.1%

Decontam Autoclave5.5%

Lab Vac system3.7%

Boiler2.2%

Figure 7: Site water consumption breakdown by users.

3 Energy Management

Energy management is an all-encompassing process that should include every aspect of an

organisation from finance, human resources and public relations to maintenance, purchasing

and planning.

A more formalised energy management system would aid the Shanbally facility by ensuring

that energy intensive operations are proceduralised and hence operated in a consistent and

energy efficient manner. This can aid staff in quantifying and tracking energy consumption on

an ongoing basis with a view to its reduction. It would also ensure the sustainability of the

energy conscious work ethos that is currently in place within the Shanbally site.

It is thus recommended to develop an opportunities register which would help to track

opportunities for improvement in energy efficiency from their identification through to their

successful implementation. The use of the Pfizer Green Buildings Evaluation Tool (discussed

in more detail in Section 4.1) demonstrates the facilities commitment to the identification and

implementation of energy saving opportunities, but a formalised register would add to this by

ensuring that good ideas are documented and hence not lost.

An Energy policy document should also be formulated and communicated to all staff and the

general public to show Pfizer Shanbally’s commitment to energy reduction. This would not

only help to make staff aware of the energy management programme but would also serve as

a useful Public Relations tool.

An annual review should also be undertaken with senior management to ensure that their

support is achieved and that more importantly that due credit is obtained for the good work

being undertaken. This will aid the site in obtaining resources for future energy saving

projects.

The implementation of Energy Performance Indicators (EPI’s) to monitor the ongoing use of

energy onsite is also recommended. EPI’s are an extremely beneficial tool in identifying

periods of energy underperformance. An EPI with effective limits set against a period of

optimum operation will allow issues such as degrading equipment or inefficient operation to

be identified as early as possible thus increasing productivity and reducing waste.

Figure 8 details an Energy Management Matrix for the Pfizer Shanbally facility at present.

With improvements and the introduction of a formalised Energy Management System it

would be hoped the facility would strive for a level four rating in all aspects of the Matrix.

Leve

l

Energy management policy Organising Staff motivation Tracking, monitoring

and reporting systems

Staff awareness/ training and promotion

Investment

4

Energy management policy, action plan and regular review have commitment of top management as part of a corporate strategy. Energy management fully integrated into management structure.

Clear delegation of responsibility for energy consumption.

Formal and informal channels of communication regularly exploited by energy manager and energy staff at all levels.

Comprehensive system sets targets, monitors consumption, identifies faults, quantifies savings and provides budget tracking.

Marketing the value of energy efficiency and the performance of energy management both within the organisation and outside it.

Positive discrimination in favour of energy saving schemes with detailed investment appraisal of all new building, equipment and refurbishing opportunities.

3Formal energy management policy, but no active commitment from top management.

Energy manager accountable to energy committee representing all users, chaired by a member of the managing board.

Energy committee used as main channel together with direct contact with major users.

Monitoring and targeting reports for individual premises based on submetering, but savings not reported effectively to users.

Program of staff training, awareness and regular publicity campaigns. Some payback criteria employed as for all other investment.

Cursory appraisal of new building, equipment and refurbishment opportunities.

2Unadopted energy management policy set by energy manager or senior departmental manager.

Energy manager in post, reporting to ad-hoc committee, but line management and authority unclear.

Contact with major users through ad hoc committee chaired by senior departmental manager.

Monitoring and targeting reports based on supply meter data.

Energy unit has ad hoc involvement in budget setting. Some ad-hoc staff awareness and training.

Investment using short-term payback criteria only.

1

An unwritten set of guidelines. Energy management the part-time responsibility of someone with only limited authority and influence.

Informal contacts between energy manager and a few users.

Cost reporting based on invoice data.

Energy manager compiles reports for internal use within technical department.

Informal contacts used to promote energy efficiency. Only low-cost measures taken.

0

No explicit policy. No energy manager or any formal delegation of responsibility for energy consumption.

No contact with users. No information system. No accounting for energy consumption.

No promotion of energy efficiency.

No investment in increasing energy efficiency in premises

Figure 8: Pfizer Shanbally Energy Management Matrix.

4 Opportunities for Energy Saving

4.1 Recent/Existing Energy Saving Initiatives

Energy efficiency is a key operational requirement at the Pfizer Shanbally facility. As such a

detailed study of the facility was conducted utilising the Pfizer Green Building Initiative

which is a systematic approach to reduce overall building lifecycle costs and the associated

benefits to the environment.

The Pfizer Green Buildings Evaluation Tool (PGBET) was developed as a result of the Green

Building Initiative with the aim of utilising the expertise that exists within the Pfizer group to

minimise environmental and energy costs and help in the conservation of natural resources.

The PGBET uses the US Green Building Council document “Leadership in Energy and

Environmental Design (LEED) New Construction V2.2” as a framework for its approach.

As a result of employing PGBET at Shanbally a number of energy saving initiatives were

considered during the design and construction of the facility. A building energy model was

employed to evaluate alternative design strategies in conjunction with their associated costs to

determine the resultant benefits. Therefore an energy efficient building was arrived at through

the consideration of a large number of design options. The process realised a number of

energy saving initiatives including:

• the optimisation of building orientation and layout thereby enabling the most efficient

use of solar heating and day-lighting;

• the use of daylight sensors and automatic dimming control for the lighting system in

conjunction with high efficiency lighting fixtures and fittings;

• a highly insulated building envelope was constructed;

• high efficiency appropriately size HVAC systems are utilised throughout the facility;

• variable speed drives, high efficiency motors and variable air volume systems are

utilised throughout the facility;

• heat recovery systems are employed;

• high efficiency energy star appliance are utilised with the Shanbally site;

4.2 Suggested Opportunities for Energy Savings

A number of opportunities for further energy savings at the site were identified. These

opportunities are both technical and organisational which will in time realise savings in

energy within the Shanbally facility. The opportunities should be entered into a formalised

opportunities register.

• Investigate implementing a formal energy management system in conjunction with

ISO:14001;

• Improve the energy monitoring of the significant energy users within the facility

through the implementation of EPI's;

• Investigate the low compressed air load when the plant is fully operational;

• Review the operation of the plant equipment once fully operational to assess the

efficient turndown of equipment during normal operations;

• Investigate the potential to further reduce the number of air changes per hour that are

utilised in production areas;

• Challenge the HVAC system humidity requirements in production areas;

• Investigate the possibility of passing reheat valves in the air handling units (AHU’s) as

8˚C heat gains were indicated in some rooms;

• Investigate the reasoning for the operation of the boiler at a low level of total dissolved

solids (TDS) and operate the boiler at 3500ppm once normal operations have been

established.

The suggested opportunities for energy savings outlined above were identified at an early

stage in the lifecycle of the facility. Therefore it is recommended that a follow-up audit should

be conducted when normal operations have been established at the site. Energy saving

calculations have not been calculated for the potential energy savings due to the relatively

early stage in the life cycle of the facility and due to the lack of normal usage patterns.

The opportunities for improvement are primarily based on sound energy management

principles of formal energy management. This is as a result of the energy efficient design

principles adopted during the design and construction of the facility and the use of “Green

Buildings Evaluation Tool”. These opportunities will assist in maintaining the energy savings

that have been designed into the facility.

Attachment III Site Noise Survey

DOCUMENT CONTROL SHEET

Client Pfizer Biotechnology Ireland

Project Title Environmental Noise Survey

Document Title IPPC Noise Report 2010

Document No. MCE0623Rp0001D01

DCS TOC Text List of Tables List of Figures No. of Appendices This Document

Comprises 1 1 8 1 - 4

Rev. Status Author(s) Reviewed By Approved By Office of Origin Issue Date

D01 Draft R. Daly D. Kingston D. Kingston A. Ryan Cork March 2010

Pfizer Biotechnology Ireland Noise Survey

IPPC Noise Report 2010

TABLE OF CONTENTS

1 INTRODUCTION ...................................................................................................... 1 1.1 Existing Environment 1 1.2 Noise Assessment Methodology 1 1.3 Monitoring Locations 2

2 SURVEY RESULTS .................................................................................................. 3 2.1 Site Boundary Locations 3

2.2.1 Southern Site Boundary: B1 3 2.2.2 Western Site Boundary: B2 3

2.3 Noise Sensitive Locations 4 2.3.1 NSL 1 – Port of Cork/Deepwater Berth Entrance 4 2.3.2 NSL 2 – Shanbally Church 4 2.3.3 NSL 3 – Local Road West of Pfizer Golf Course 4 2.3.4 NSL 4 – Residential Property at Ballyfouloo 5 2.3.5 NSL 5 – Residential Property at Monkstown Rise 5 2.3.6 NSL 6 – Monkstown Road - Residential Property “Corr Iasc” 5 2.1.1 NSL7 – Monkstown Demesne – Residential Properties 6

3 DISCUSSION............................................................................................................ 18 3.1 Site Boundary Locations 18 3.2 Noise Sensitive Locations 18

3.2.1 Night-Time Measurement 18 3.2.2 Daytime Measurement 19

4 CONCLUSION ......................................................................................................... 21

List of Tables

Table 1.1: Description of Noise Monitoring Locations .................................................................2 Table 2.1: Noise Measurements at B1 .......................................................................................3 Table 2.2: Noise Measurements at B2 .......................................................................................3 Table 2.3: Noise Measurements at NSL 1..................................................................................4 Table 2.4: Noise Measurements at NSL 2..................................................................................4 Table 2.5: Noise Measurements at NSL 3..................................................................................5 Table 2.6: Noise Measurements at NSL 4..................................................................................5 Table 2.7: Noise Measurements at NSL 5..................................................................................5 Table 2.6: Noise Measurements at NSL 6..................................................................................6 Table 2.7: Noise Measurements at NSL 7..................................................................................6

Appendices

APPENDIX A Survey Details

APPENDIX B Glossary of Terms

APPENDIX C 1/3-Octave Frequency Spectrum Graphs

APPENDIX D Noise Sensitive Measurement Locations

2 INTRODUCTION RPS was commissioned by John F. Morrissey of Pfizer Biotechnology Ireland, Shanbally, Ringaskiddy, Co. Cork to conduct a noise survey in accordance with Condition 6.12 of Pfizer Biotechnology’s IPPC License (Reg. No P0864-01), and to prepare a Technical Report giving full details of the noise surveys, results and conclusions. Condition 6.12 of the license states that

“The licensee shall carry out a noise survey of the site operations annually. The survey programme shall be undertaken in accordance with the methodology specified in the ‘Environmental Noise Survey Guidance Document’ as published by the Agency.”

In addition Schedule B.4 specifies the following License limits and condition for noise levels at noise sensitive receptors:

Daytime: LAeq30mins 55dB(A) Night: LAeq30mins 45dB(A) Note 1: There shall be no clearly audible tonal component or impulsive component in the noise emission from the activity at any noise sensitive location.’

RPS subsequently visited the site on March 3rd and 4th, 2010 to conduct a day and night-time noise survey at the noise sensitive locations. Noise measurements were also carried out at specific site boundary locations. The findings of the survey are summarized in this report. (A summary of the terminology used in this report is given in Appendix B). 2.1 EXISTING ENVIRONMENT The Pfizer Biotechnology site is located in Shanbally, Ringaskiddy, Co. Cork, which lies in the greater lower estuary area of Cork Harbour. The site is bounded to the north by the shoreline of Monkstown Creek – further to the north can be considered a residential area of Lower Monkstown and amenity walk along Ballinaclashet (Monkstown) Creek. To the east, the site shares a boundary with the Pfizer’s Ringaskiddy API plant, which is overlooked by the Port of Cork. To west, the site shares a boundary with the Pfizer golf and social club. Shanbally village and residential housing bound the golf course to the west. To the north, the site is bounded by the N28 and vacant agricultural land. The site operates over a 24-hour period therefore night-time noise levels were measured at the nearest noise sensitive locations, in accordance with the requirements of Condition 6.12 and Schedule B4. 2.2 NOISE ASSESSMENT METHODOLOGY A noise survey was conducted on the boundary of the site, and at the nearest noise sensitive locations. A description of each location is included in Table 1 and illustrated in Appendix D. In addition, 1/3-octave band noise frequency was also measured to assess potential tonal components, which may be used to identify specific noise sources at the sensitive receptors.

In accordance with ISO 1996 – 2, a source is described as having a tonal component at a particular frequency when it is clearly audible or exceeds the level of the adjacent band by 5dB or more. Note: Where a definitive tone is detected at noise sensitive receptors, a 5dB penalty is incurred, which is added to the overall LAeq. However, this is also dependent upon noise emissions from the Pfizer facility being the source of the tonal component. The 1/3-octave frequency analysis graphs are attached as Appendix C.

2.3 MONITORING LOCATIONS

The survey included ambient environmental noise measurements at both onsite locations and noise sensitive locations within the surrounding area of the Pfizer Biotechnology Plant at Ringaskiddy. Table 1.1: Description of Noise Monitoring Locations

Location Reference Description

B1 Southern Site Boundary B2 Western Site Boundary

NSL 1 Port of Cork/Deep Water Berth Entrance – within 20m of residential homes NSL 2 Shanbally Church car park – centre of Shanbally village NSL 3 Residential property overlooking Pfizer Golf Course NSL 4 Residential properties at Ballyfouloo NSL 5 Residential properties at Monkstown Rise NSL 6 Monkstown Road - Residential property “Corr Iasc” NSL 7 Monkstown Demesne – residential properties

The following equipment was used for the noise survey:

• Brüel & Kjær Type 2260 Sound Level Meter

• Brüel & Kjær Type 4231 Sound Level Calibrator Measurements were made at a height of 1.5m above ground level, and measurements were free field, taken at least 2m from reflecting surfaces. The weather conditions were in accordance with the requirements of ISO 1996: Acoustics – Description and Measurement of Environment Noise. Further Survey details are included in Appendix A. Some light wind conditions and light infrequent rain showers were present during the surveys, however all measurements were paused during adverse weather conditions, and hence during all surveys were in accordance with the requirements of ISO 1996. (See Appendix A for details of weather data). The instrumentation was checked and calibrated before and after the survey period to ensure no drift in the instruments sensitivity had occurred. Further survey details are included in Appendix A.

3 SURVEY RESULTS A summary of the measured noise levels is presented below for each location as specified in the license. 1/3rd octave band analysis was measured at all locations during the survey period to assess the presence of tonal components in the measured noise. Graphs of frequency analysis trends (1/3 Octave/Tonal Trending) are shown in Appendix C. Figures 1 - 9 illustrate the measured frequency analysis at two boundary locations and at seven noise sensitive locations, while the plant was in operation. 2.1 SITE BOUNDARY LOCATIONS

2.2.1 Southern Site Boundary: B1

The dominant noise source at this location during the night-time measurement was from intermittent traffic passing on the main Ringaskiddy Road. In the absence of traffic, noise from the plant on the northern side of the API Plant and western side of the Biotechnology Plant were notable, but not considered significant.

During the daytime measurement the dominant noise source was the steady flow of traffic on the Ringaskiddy Road. Measurement was paused as HGV passed. Plant noise was only slightly audible during lulls in traffic.

Tonal noise was not detected from either night-time or daytime measurements. Table 2.1: Noise Measurements at B1

Measurement Time

Measurement Duration LAeq LAmax LAmin LA10 LA90

23.03 03/03/10 30 mins 45.9 60.9 37.2 50.2 39.6

12.48 04/03/10 30 mins 55.1 65.4 42.2 58.2 48.0

2.2.2 Western Site Boundary: B2

During the night-time measurement the ambient noise was dominated by plant noise from the northern side of the API Plant. Low-level plant noise was apparent from the western side of the Biotechnology facility. Traffic noise was also influential emanating from the Ringaskiddy Road. Occasional birds’ calls were also noted from Monkstown Creek.

During the daytime measurement the most dominant source of noise was road traffic noise on the Ringaskiddy Road. Background noise from the Biotechnology plant was also noted but only barely audible. Occasional bird calls were also noted from Monkstown Creek.

Tonal noise was not detected from either night-time or daytime measurements. Table 2.2: Noise Measurements at B2

Measurement Time


23.54 30 mins 41.1 60.7 36.0 42.4 39.0 13.26 30 mins 47.1 66.0 42.6 48.6 44.6

2.3 NOISE SENSITIVE LOCATIONS

2.3.1 NSL 1 – Port of Cork/Deepwater Berth Entrance

The night-time measurement was dominated by intermittent traffic noise on the Ringaskiddy road – highest noise observed from passing HGV’s. In the absence of traffic noise, occasional industrial noise was audible towards the east/southeast. The Pfizer site was inaudible. During the daytime measurement, traffic on the Ringaskiddy Road was again the dominant source as HGV’s entered and exited the Port of Cork – Deep Water Berth. Frequent birdcalls were also influential on the ambient noise level. Tonal noise was not detected from either night-time or daytime measurements. Table 2.3: Noise Measurements at NSL 1

Measurement Time


22.23 30 mins 59.5 79.0 30.2 59.4 34.8 11.23 30 mins 67.1 84.3 40.0 72.0 47.0

2.3.2 NSL 2 – Shanbally Church

The night-time noise environment was dominated by occasional passing traffic through Shanbally. Low-level plant noise was audible during lulls in traffic but the plant noise was not considered significant. [Noise measurement was paused as vehicles exited car park and as people vacated the local public house]. The daytime measurement was dominated by a combination of traffic passing through Shanbally village and local traffic using the church car park. In addition, the car park gate was opened and closed frequently producing additional noise in the immediate vicinity of the measurement. Plant noise was inaudible. Tonal noise was not detected from either night-time or daytime measurements. Table 2.4: Noise Measurements at NSL 2

Measurement Time


00.50 30 mins 46.1 69.5 30.9 48.4 34.0 14.10 30 mins 60.3 78.6 45.0 63.4 51.2

2.3.3 NSL 3 – Local Road West of Pfizer Golf Course

During the night-time measurement, the ambient noise levels were initially affected by a dog barking in a nearby house. Low-level plant noise was audible in distance towards the east, but not considered a significant source. No local traffic occurred during the measurement period. Occasional birdcalls were audible from Monkstown Creek. The daytime measurement was predominantly influenced by traffic on the adjacent road through Shanbally – passing traffic included motorcycles and tow-truck. Traffic on the N28 was also noted. Occasional birdcalls were audible as were noise from people on the golf course. Plant noise was not audible during the measurement.

Tonal noise was not detected from either night-time or daytime measurements. Table 2.5: Noise Measurements at NSL 3

2.3.4 NSL 4 – Residential Property at Ballyfouloo

The dominant noise source noted during the night-time measurement was the sound of water flowing from streams and drains into Monkstown Creek. A single vehicle passed during the measurement on the R614. There was no plant noise apparent/audible from the Pfizer facility. Traffic noise from the R614 was significant during the daytime measurement. A single car passed on a local road adjacent to the monitoring position. Additional noise included occasional barking dog, birdcalls and a single overhead aircraft. Tonal noise was not detected from either night-time or daytime measurements. Table 2.6: Noise Measurements at NSL 4

2.3.5 NSL 5 – Residential Property at Monkstown Rise

During the night-time measurement the dominant noise source was generally occasional passing traffic on local road. In the absence of passing traffic, plant noise from Pfizer facility was noticeable. Additional noise included occasional birdcalls from Monkstown creek. Traffic noise from the R614 was significant during the daytime measurement and was dominant throughout the measurement. Birdcalls were also noticeable as was the sound of a chainsaw in use towards the west. Tonal noise was not detected from either night-time or daytime measurements. Table 2.7: Noise Measurements at NSL 5

2.3.6 NSL 6 – Monkstown Road - Residential Property “Corr Iasc”

The night-time measurement detected a low level of plant noise from the Pfizer API facility. Occasional passing vehicles were noted which dominated the ambient noise whilst passing. Bird calls from Monkstown Creek were also audible.

Measurement Time


15.07 30 mins 56.5 81.5 26.7 34.4 29.8 15.25 30 mins 56.1 80.0 36.9 51.0 41.0

Measurement Time


02.12 30 mins 40.5 70.5 26.6 31.0 27.8 16.10 30 mins 62.2 80.7 39.1 66.0 43.8

Measurement Time


02.50 30 mins 43.6 72.9 28.9 36.4 31.0 16.51 30 mins 62.4 78.8 40.5 67.6 44.6

Tonal Noise was detected during the night-time measurement – a tone at 63Hz was detected (see Appendix C – Figure 8). The source of the tonal component was not apparent on-site during the noise survey but it may have been associated with one of the vehicles that passed during the survey. Traffic noise from the R614 was significant during the daytime measurement. A tugboat passing downriver towards the greater harbour was also noted for approximately 5-minutes during the measurement period. Other additional sources of occasional noise included birdcalls and a single overhead small aircraft. Plant noise was audible during brief lulls in traffic, but plant noise was not considered significant. Tonal Noise was detected during the daytime measurement – a tone at 100Hz was detected (see Appendix C – Figure 8). From field observations, it is considered that the most likely source of the tonal component was the tug boat, which passed downriver during the survey.

Table 2.6: Noise Measurements at NSL 6

3.1.1 NSL7 – Monkstown Demesne – Residential Properties

The night-time measurement was generally a very quiet period at this location. There were no apparent dominant noise sources. Local sources included leaf rustle from nearby foliage and some occasional birdcalls. Plant noise was inaudible.

The dominant daytime noise was from birdcalls and people in the general area. There was no local traffic noise; however traffic in Monkstown was slightly audible. Plant noise was not audible.

Tonal noise was not detected from either night-time or daytime measurements.

Table 2.7: Noise Measurements at NSL 7

Measurement Time


04.22 30 mins 47.3 77.9 30.9 36.6 33.0 17.27 30 mins 68.7 81.2 41.8 74.0 45.0

Measurement Time


04.59 30 mins 36.3 60.9 31.4 37.6 33.8 18.14 30 mins 45.0 64.5 37.0 46.6 39.6

3 DISCUSSION

3.1 SITE BOUNDARY LOCATIONS

Night-Time Measurements

The night-time LAeq noise levels ranged from a high of 45.9dB(A) at B1 to low of 41.1dB(A) at B2. The main contributing noise sources at each boundary were frequent to intermittent traffic with steady and continuous plant noise. No onsite tones were detected.

Daytime Measurements

The elevated daytime LAeq levels when compared to the night-time measurements can be attributed to increased traffic levels on the Ringaskiddy Road. No tones were detected during the daytime survey. The noise limits as specified in the IPPC licence were not exceeded by any noise sources on-site at the Pfizer Biotechnology facility. Exceedances were associated with external noise sources and as such are not subject to the conditions of the IPPC licence.

3.2 NOISE SENSITIVE LOCATIONS

3.2.1 Night-Time Measurement

A low level background sound from the Pfizer facility was audible at locations NSL2, NSL3, NSL5 and NSL6 during the night-time measurements. The Pfizer facility was not audible at NSL1, NSL4 and NSL7. While NSL2, NSL3 and NSL6 were above the night-time noise limit of 45dB(A), the elevated noise levels were attributed to traffic and not derived from an industrial source. Where road traffic is considered a dominant noise source, examining background noise levels (LA90) can display more indicative noise levels of the ambient environment. In this case all LA90 results from night-time measurements were below 45dB (A). A single tone was detected at NSL6 but the source of the tonal component was not apparent during the noise survey. As outlined above it is considered likely that the tonal component may have been associated with a passing vehicle during the survey.

3.2.2 Daytime Measurement

During the daytime surveys, traffic (private and commercial) and other typical urban activities including use of a chainsaw, barking dogs, birdsong, aircraft and harbour movements contributed significantly to the noise level at each location. In the majority of cases plant noise was inaudible. Plant noise was only audible for brief periods at NSL6. A single tone (100Hz) was recognised at NSL6, but can be attributed to a tugboat, which was passing down river during the survey and was noted as a significant source of noise for a period of approximately 5 minutes during the survey at this location.

4 CONCLUSION

Day and night-time noise monitoring was carried out in accordance with IPPC License P0864-01. While levels in excess of the IPPC license limit values were measured during the course of the surveys at noise sensitive locations NSL 1 – 6 it is the conclusion of this report that these levels are neither attributable to nor representative of the noise contribution of the Pfizer Biotechnology site, to the local noise climate. The background noise levels (LA90) are more representative of the contribution of Pfizer Biotechnology facility to the noise environment. While the Pfizer Biotechnology site is audible on occasion during lulls in traffic, it does not impose on the noise environment to a significant extent nor does it dominate the character of the noise environment in the area. A tonal noise component was not denoted at any of the boundary locations (B1-B2). With regard to the noise sensitive locations, two tones were detected at NSL 6. The daytime tone can be attributed to a tugboat, which passed downriver during the survey. The source of the night-time tone was not apparent on-site during the survey but may have been associated with a car that passed during the night-time survey. It is the conclusion of this assessment that the operation of the Pfizer Biotechnology Plant does not contribute to elevated noise levels at noise sensitive locations surrounding the site. Furthermore, the plant does not contribute to tonal or impulsive components at these locations.

APPENDIX A Survey Details

A.1 Location of Survey

Pfizer Biotechnology Ireland Shanbally, Ringaskiddy, Co. Cork

A.2 Date & Time of Survey

March 3rd, 2010 22.00 – 05.30 March 4th, 2010 10.30 – 19.00

A.3 Weather Conditions

March 3rd, 2010 Dry conditions, showers earlier that evening (roads wet but drying out). Wind conditions calm (0.0m/s - 1.6m/s). Temperature 0 – 3 ºC.

March 4th, 2010 Bright and dry conditions. Slight north/northwesterly

breeze. Wind conditions calm (1.7m/s – 2.0m/s) Temperature 4 - 6 ºC.

A.4 Personnel Present During Survey

Darragh Kingston - Acoustic Consultant RPS Group

A.5 Instrumentation

Brüel & Kjær Type 2260 Investigator Brüel & Kjær Type 4231 Sound Level Calibrator

A.6 Calibration

Before and after the survey the measurement apparatus was check calibrated to an accuracy of +0.24dB using the Type 4231 Sound Level Calibrator. The calibration produces a sound pressure level of 94.0dB re 2x10-5Pa at a frequency of 1kHz.

A.7 Methodology

Sample periods at the noise-sensitive locations and boundaries consisted of thirty-minute measurements during night-time and daytime surveys. All measurements were carried out in accordance with ISO 1996: Description and Measurement of Environmental Noise (Parts 1, 2 and 3).

APPENDIX B Glossary of Technical Terms

In order to understand the terms used, appropriate definitions are outlined as follows: - LAeq Is the A-weighted equivalent continuous sound level during a sample time

period and effectively represents an average value i.e. the average level recorded over the sampling period and includes all noise events. The closer the LAeq value is to either the LAF10 or LAF90 value indicates the relative impact of the intermittent sources and their contribution. The relative spread between the values determines the impact of noise on the background. The LAeq value has been found to correlate well with human tolerance of noise, and is the value normally used in setting and monitoring industrial noise limits.

LAF10 Refers to those levels in the top 10 percentile of the sampling interval; it is the

level that is exceeded for 10% of the measurement period. It is used to determine the intermittent high noise level features of locally generated noise, i.e. the higher noise levels present in the ambient noise.

LAF90 Refers to those levels in the lower 90 percentile of the sampling interval; it is

the level that is exceeded for 90% of the measurement period. It is used to estimate a background level. It tends to exclude short events such as occasional cars passing (but less so for regular passing traffic), dogs barking, aircraft flyovers etc.

LAMax The LAMax is the maximum reading measured at the sound level meter. It gives

an indication of the highest noise produced by a varying noise source. LAMin The LAMin is the minimum reading measured at the sound level meter. It gives

an indication of the lowest noise produced by a varying noise source. A-weighting is the process by which noise levels are corrected to account for the non-

linearity of human hearing. dB(A) A logarithmic noise scale (decibel). The “A” indicates that a frequency

weighting has been applied to take account of the variation in the sensitivity of the human ear as a function of frequency.

All quoted noise levels are relative to 2x10

-5 Pa.

APPENDIX C 1/3 Octave Frequency Analysis

B1 - 1/3 Octave Trend

05

101520253035404550

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

23.0312.48

Figure 1 – Location B1 – 1/3 Octave Trend

B2 - 1/3 Octave Trend

05

10152025303540

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

23.5413.26

Figure 2 – Location B2 – 1/3 Octave Trend

NSL1 - 1/3 Octave Trend

05

1015202530354045505560

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

22.2311.23

Figure 3 – Location NSL1 – 1/3 Octave Trend


05

10152025303540455055

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

00.5014.10

Figure 4 – NSL2 – 1/3 Octave Trend


05

10152025303540455055

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

01.3214.50


NSL 4 - 1/3 Octave Trend

05

1015202530354045505560

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

02.1216.10



05

1015202530354045505560

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

02.5016.51



05

101520253035404550556065

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

04.2218.01



05

10152025303540

12.5 20

31.5 50 80 125

200

315

500

800

1.2

5k

2k

3.1

5k

5k

8k

12.5

k

20k

Frequency (Hz)

Soun

d Pr

essu

re (d

B)

04.5918.14


APPENDIX D

Site Layout and Measurement Locations

Figure 10 – Noise Sensitive Locations

Location Reference Description

B1 Southern Site Boundary B2 Western Site Boundary

NSL 1 Port of Cork/Deep Water Berth Entrance – within 20m of residential homes NSL 2 Shanbally Church car park – centre of Shanbally village NSL 3 Residential property overlooking Pfizer Golf Course NSL 4 Residential properties at Ballyfouloo NSL 5 Residential properties at Monkstown Rise NSL 6 Monkstown Road - Residential property “Corr Iasc” NSL 7 Monkstown Demesne – residential properties

NSL1

NSL2

NSL3

NSL4

NSL6

NSL5

NSL7

B1 B2

Attachment IV - Pipeline Test Report

Attachment V - Bund Test Report

FIRE WATER TANK

Attachment VI - Environmental Liabilities Risk Assessment


ELRA

Environmental Liability Risk Assessment

ISSUE 1


ELRA

Environmental Liability Risk Assessment

May 2009

This report takes into account the

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Pfizer Biotechnology Ireland ELRAEnvironmental Liability Risk Assessment



Issue 1 28 May 2009

Contents

Page EXECUTIVE SUMMARY Error! Bookmark not defined.

1 INTRODUCTION .....................................................................................................2 2 SITE ASSESSMENT ................................................................................................2

2.1 Complexity 3 2.2 Environmental Sensitivity 3 2.3 Compliance Record 4 2.4 Outcome and Risk Category 4

3 ENVIRONMENTAL LIABILITY RISK ASSESSMENT ....................................6 3.1 Scope 6 3.2 Methodology 6 3.3 Risk Identification 7 3.4 Assessment of Risks 18 3.5 Risk Prevention, Mitigation and Management 20 3.6 Financial Liability 24 3.7 Review of ELRA 25

4 FINANCIAL PROVISION.....................................................................................27 5 REFERENCES ........................................................................................................27



Page 1 Arup Consulting EngineersIssue 1 28 May 2009

EXECUTIVE SUMMARY This Environmental Liability Risk Assessment (ELRA) for the Pfizer Monoclonal Antibodies (MAbs) Small Scale Facility (SSF) currently under construction at Shanbally, Ringaskiddy, Co. Cork has been undertaken in accordance with the methodology outlined in the EPA Guidance Document.

Environmental risks associated with the operation of the plant were identified with reference to the Environmental Impact Statement for the facility and Process Hazard Reviews carried out for the plant. Likelihood and severity factors were assigned to the risks in order to determine the extent of the potential liability from unplanned events impacting on the environment.

As with any industrial process, during abnormal operations it is possible for environmental liabilities to occur. The worst-case financial model quantifies the unknown environmental liability at the site as €2,200. In general, the risk associated with abnormal activities on-site is considered to be acceptable and therefore the environmental liability costs would be covered by Pfizer’s public liability insurance.




• INTRODUCTION This Environmental Liability Risk Assessment (ELRA) was prepared to comply with Condition 12 of IPPC licence – P0864-01 for the Pfizer Monoclonal Antibodies (MAbs) Small Scale Facility (SSF), known as Pfizer MAbs SSF, currently under construction at Shanbally, Ringaskiddy, County Cork.

In particular, the ELRA has been developed to satisfy the following sub-clauses 12.2.2 and 12.2.4 of Condition 12:

12.2.2 The licensee shall arrange for the completion, by an independent and appropriate qualified consultant, of a comprehensive and fully costed Environmental Liabilities Risk Assessment (ELRA) to address the liabilities from past and present activities. The assessment shall include those liabilities and costs identified in Condition 10 for execution of the DMP. A report on this assessment shall be submitted to the Agency for agreement in advance of the commencement of the activity. The ELRA shall be reviewed as necessary to reflect any significant change on site, and in any case every three years following initial agreement. The results of the review shall be notified as part of the AER.

12.2.4 The licensee shall have regard to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Decommissioning Management Plans and Financial Provision when implementing Conditions 12.2.2 and 12.2.3 above.

The first step in the preparation of an ELRA, recommended in the EPA’s Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision [1], is to identify the risk category of the facility. The screening and operational risk assessment for the Pfizer Monoclonal Antibodies (MAbs) Small Scale Facility (SSF) has been undertaken in accordance with the methodology outlined in the guidance document (refer to section 2).

The screening and operational risk assessment indicated the requirement for a generic ELRA.

• SITE ASSESSMENT A risk assessment decision matrix has been developed, to classify the Pfizer MAbs SSF site into one of the three Risk Categories as outlined in the EPA Guidance.

The three aspects of the facility which determine the overall risk category of the facility are as follows:

• Complexity – the extent and magnitude of potential hazards present due to the operation of the facility, e.g. a function of the nature of the activity, the volumes of hazardous materials stored on site etc.

• Environmental Sensitivity – the sensitivity of the receiving environment in the vicinity of the facility, with more sensitive locations given a higher score

• Compliance Record – the compliance history of the facility and whether soil and/or groundwater contamination is present below the site.

Tables 1- 3 show how the environmental sensitivity and risk category for the site were determined.




o Complexity

The activity ‘use of a chemical or biological process for the production of basic pharmaceutical products (Class 5.16 of the First Schedule the Protection of the Environment Act ); where annual production <2000 tonnes’ is assigned a complexity of G3, using the Environmental Agency (England and Wales) Environmental Protection Operator and Pollution Risk Appraisal methodology.

The Pfizer MAbs SSF will engage in activity class 5.16 and the annual production will be less than 2000 tonnes. For the purposes of the risk assessment, the complexity value G3 = 3.

o Environmental Sensitivity

Environmental sensitivity is considered with respect to six potential receptors:

• Human beings

• Groundwater

• Surface water

• Air quality

• Protected ecological sites

• Sensitive agricultural receptors.

Human Beings The nearest dwelling to the site is 385 metres from the western boundary. This is assigned an environmental attribute score of 1 (EPA 2006 p13).

Groundwater Protection The site is underlain by a locally important aquifer, with a high vulnerability [2]. This is assigned an environmental attribute score of 1+ 2 = 3 (EPA 2006 p13).

Sensitivity of Receiving Waters The storm water and treated process wastewater will discharge to Cork Harbour, which is not designated under the Urban Waste Water Treatment Regulations (2001), nor are the discharge zones potentially eutrophic coastal and estuarine waters. This is assigned an environmental attribute score of 0 (EPA 2006 p13).

Air Quality and Topography The terrain in the vicinity of the site is ‘simple terrain’, which is assigned an environmental attribute score of 0 (EPA 2006 p13).

Protected Ecological Sites and Species The site borders the Monkstown Creek proposed NHA, and is therefore assigned an environmental attribute score of 2 (EPA 2006 p13).

Sensitive Agricultural Receptors Dairy farming is carried out across the road from the site, within 50 metres of the activity footprint. An environmental attribute score of 2 is therefore assigned.

Total Environmental Attribute Score A total environmental attribute score of 8 is assigned by summing the individual environmental attribute scores. This is classified as ‘moderate’, and is assigned an Environmental Sensitivity Classification of 2.




o Compliance Record

The Pfizer MAbs SSF will be a newly licensed facility, and will therefore have a compliance record score of 1 (EPA 2006 p15).

o Outcome and Risk Category

The product of the complexity score (3), the environmental sensitivity score (2) and the compliance record (1) is 6. This is considered Risk Category 2 (EPA 2006 p10).

As a Risk Category 2 site a generic ELRA is required (EPA 2006 p26).

Tables 1- 3 show how the environmental sensitivity, risk category and hazard potential for the site were determined.

Table 1 Environmental Sensitivity

TOTAL Environmental Attribute Score Environmental Sensitivity Classification

Low <7 1

Moderate 7-12 2

High >12 3

Table 2 Risk Category

Risk Category Overall Risk Score

Category 1 <5

Category 2 5-23

Category 3 >23




Table 3 Operational Risk Assessment

Complexity Score

Licensed Activity Class

Use of a chemical or biological process for the production of basic pharmaceutical products (Class 5.16 of the First Schedule the Protection of the Environment Act ); where annual production <2000 tonnes’

G3 3

Environmental Sensitivity

Sub Matrix Score

Score

Human Occupation

250m – 1000m from site boundary 1

Groundwater Protection

Locally important aquifer 1

Vulnerability rating – high 2

Sensitivity of Receiving Waters

Coastal and estuarine waters - not designated, not potentially eutrophic

0

Protected Ecological Sites

Directly bordering a protected site 2

Air Quality & Topography

Simple terrain 0

Sensitive Agricultural receptors

Fruit, vegetable or dairy farming < 50m from site boundary

2

Total Environmental Sensitivity 8 2 (moderate)

Compliance Record

Newly licensed facility 1

OVERALL RISK SCORE

(Complexity x Environmental Sensitivity) x Pollution Record

(3 x 2) x 1 6

RISK CATEGORY 2




• ENVIRONMENTAL LIABILITY RISK ASSESSMENT o Scope

This section addresses the liabilities from past and present activities on the site.

o Methodology

The assessment of the risk of a facility to the environment is based on two risk classification tables. Table 4 describes the likelihood of occurrence of an event. Table 5 describes the severity of the impact if the event occurs (EPA 2006 p29).

Table 4 Risk Classification Table – Occurrence

Occurrence Rating

Category Description Likelihood of Occurrence (%)

1 Very Low Very low chance (0-5%) of hazard occurring in 30 year period *

0 – 5

2 Low Low chance (5-10%) of hazard occurring in 30 year period

5 - 10

3 Medium Medium chance (10-20%) of hazard occurring in 30 year period

10 - 20

4 High High chance (20-50%) of hazard occurring in 30 year period

20 - 50

5 Very High Greater than 50% chance of hazard occurring in 30 year period

>50

* The assessment of the environmental liabilities has been limited to a 30-year period in accordance with Article 10 of the Council Directive 1999/31/EC of 26 April 1999 on the Landfill of Waste.

Table 5 Risk Classification Table – Severity

Occurrence Rating

Category Description Cost of Remediation

1 Trivial No damage or negligible change to the environment.

€ 0-1,000

2 Minor Minor impact/localised or nuisance

€ 1,000-10,000

3 Moderate Moderate damage to environment

€ 10,000-50,000

4 Major Severe damage to local environment

€ 50,000-100,000

5 Massive Massive damage to a large area, irreversible in medium term

€ 100,000-500,000




o Risk Identification

In Table 6, risks are identified and severity and occurrence ratings assigned on the basis of potential environmental impacts and proposed preventative and mitigatory measures and circumstances.

Operations on-site were examined to determine the potential for environmental liabilities to arise. The Environmental Impact Statement [2] for the proposed facility and Process Hazard Reviews [3] were referred to in identifying environmental liabilities. A total of 20 plausible



Page 8 Arup Consulting Engineers

Table 6 Risk Assessment Form

Risk ID Area Potential

Hazards Environmental

Effect Severity Rating Basis of Severity Rating

Occurrence

Rating Basis of Occurrence Rating Risk Score

1. Wave bioreactor seed train

Large volume cell culture spill

Risk of Group 1 agent environmental release

1 CHO cells, and CHOK1SV in particular, are non-pathogenic, have a long history of safe laboratory use and are classified as Class 1. The insert, vectors and expressed gene product are not considered harmful or capable of altering the pathogenicity/survivability/ fitness of the recipient/host organism. On this basis the GMM does not pose a risk to human/animal/plant health or the environment.

3 An accidental bioreactor spill would be directed to the biowaste inactivation vessel by opening a floor drain in the cell culture suite intended for this situation only. The Cell Culture Suite provides the biocontainment envelope and would be decontaminated should an accidental bioreactor spill occur. A small accidental spill in the manufacturing area would be handled by locally swabbing with a disinfectant. Cell culture room will be within the BS1-LS envelope and as such will have a ‘pressure bubble’ type airlock to prevent air leaking out of room to surrounding areas.

3







Occurrence


2. Wave bioreactor seed train

Buffer spill Risk of environmental release of buffer

1 All chemical storage areas, vessels, pipes and drainage systems will have primary, secondary and tertiary containment measures installed where possible, in order to minimise the potential for release of contaminants into the surrounding groundmass in the event of leaks or spillages. Emergency response protocols will be established to help minimise the potential for damage to the surrounding environment.

1 All materials storage and handling on-site will be controlled by SOP.

1







Occurrence


3. 500 L seed bioreactor

Over pressurisation


1 CHO cells, and CHOK1SV in particular, are non-pathogenic, have a long history of safe laboratory use and are classified as Class 1. The insert, vectors and expressed gene product are not considered harmful or capable of altering the pathogenicity/survivability/ fitness of the recipient/host organism. On this basis the GMM does not pose a risk to human/animal/plant health or the environment.

1 Back up of PSE with PSC. Likelihood of instantaneous release of complete inventory from process vessel is (5 x 10-6 y-1)2 Likelihood of continuous release from a hole of effective diameter 10 mm is (1 x 10-4 y-1)3 [4]

1


Wrong transfer panel jumper used


1 Refer to above item

3 The cells lines used are considered by regulatory authorities as being low risk with respect to human impacts. Containment system proposed is such that risk of release of micro-organisms is considered acceptably low.

3

2 Instantaneous release (from a process vessel) of complete inventory 3 Continuous release (from a process vessel) from a hole of effective diameter of 10 mm







Occurrence



Transfer started when jumper is being released


1 Refer to Risk ID 3 3 All materials storage and handling on-site will be controlled by SOP. Manual valve on transfer panel nozzles will allow operator to shut-off.

3


Incorrectly made connection


1 Refer to Risk ID 3 3 Manual valve on transfer panel nozzles will allow operator to shut-off. All materials storage and handling on-site will be controlled by SOP.

3


Overfilling Risk of Group 1 agent environmental release

1 Refer to Risk ID 3 3 High level probes to be provided. All materials storage and handling on-site will be controlled by SOP.

3

8. Production Bioreactor Chain

Large volume spill


1 Refer to Risk ID 3 3 Whole room containment. All materials storage and handling on-site will be controlled by SOP.

3

9. Purification chromatography skids and columns

Overpressurisation

Risk of environmental release

1 The GMM does not pose a risk to human/animal/plant health or the environment (refer to Item 1).

3 High pressure alarms provided on pump discharge and on chromatography column inlet. These alarms are interlocked with the pumps. Rupture disks provided.

3







Occurrence


10. Large Scale Media Preparation

Overfilling bags

Risk of environmental release of media

1 Media do not have adverse environmental effects

3 All storage and handling on-site will be controlled by SOP. Interlock provided for maximum bag capacity. Manual valves provided on transfer panel. Max air overpressure to be used will be less than bubble point of filters. LITs that can be interlocked with the vessel outlet during buffer transfer to be provided on buffer vessels.

3

11. Clean-In-Place (CIP)

Day tank ruptures

Risk of environmental release of CIP solution

1 Secondary containment around skid room

1 Low likelihood of leak occurring (5x10-6y-1)4 [4]

1

4 Single containment tank, continuous release to atmosphere over 10 minutes







Occurrence


12. CIP Inadequate alkaline concentration/temperature on inactivation part of cycle for BL1 contaminated equipment

Risk of Group 1 Agent environmental release

1 Refer to Risk ID 3 3 Process will be controlled by SOP. CIP skid automation verifies alkaline concentration and temperature before solutions sent to cell culture and harvest equipment.

3

13. Biowaste inactivation

Biowaste header becomes blocked


1 Refer to Risk ID 3 3 High level switch will be provided on biowaste header

3

14. Biowaste inactivation

Overfilling vessel


1 Refer to Risk ID 3 3 Process will be controlled by SOP. High level switch will alert DCS for operator action.

3

15. Reduced Ion Water/DI/PUR

Ozone destruct filter failure

Air pollution 1 Minor environmental impact due to rapid dilution of escaping ozone

3 Preventative maintenance of filter

3







Occurrence


16. Within site boundary

Fire Discharge to foreshore of potentially contaminated fire-water

1 A fire-water retention tank capable of holding the fire-water runoff that could result in the event of a serious fire on site and concurrent storm water will be provided. The capacity of the tank will be based calculated in accordance with EPA guidelines

1 Low chance of fire occurring due to preventative and mitigative measures employed on-site. An Emergency Response Team, trained to deal with any potential emergencies will be on-site. An Emergency Procedures Manual, setting out information on employees’ responsibilities, as well as fire, evacuation and emergency procedures, will also be put in place. Detailed fire and smoke prevention, detection and suppression measures have been incorporated into the development design. A Fire Safety Certificate an has been obtained from the Fire Authority

1







Occurrence



Fire Off-site smoke

2 Potential short-term off-site nuisance

1 Refer to Risk ID 16 2


Leak from fuel oil delivery road tanker

Spill to ground 2 A Class I oil interceptor will be installed within the surface water drainage system. A regular inspection and maintenance/desludging programme will be implemented whereby any oil/solids/debris trapped within the interceptor will be removed and disposed of off-site by an appropriately licensed contractor. Most of the site will be covered by impermeable areas either in the form of buildings or hardstanding areas, therefore very little risk to groundwater.

1 Low likelihood of leak occurring (5x10-7y-1)5 [4] Natural gas will be the primary fuel used on-site. Fuel oil will only be used in the unlikely event of failure of natural gas supply.

2

5 Continuous leak from largest road tanker connection (atmospheric tank)







Occurrence


Immediate response to spillage will be temporary containment and/or absorption. Spillages will be assessed under the provisions of the specific “action plan” for spillage in the ERP.

19. Fuel oil tank Leak from fuel oil tank

No environmental impact

1 Tanks bunded so no change to the environment. A Bund Register will be maintained by the Engineering Dept. All bunds will be subject to a three year test frequency.

1 Low likelihood of leak occurring (5x10-6y-1)6 [4]

1








Occurrence



Chemical spill/leak

Release of chemicals to the storm water drainage system and thence to the foreshore discharge point

2 All chemical storage areas, vessels, pipes and drainage systems will have primary, secondary and tertiary containment measures installed where possible, in order to minimise the potential for release of contaminants into the surrounding groundmass in the event of leaks or spillages. Emergency response protocols will be established to help minimise the potential for damage to the surrounding environment.

1 Low likelihood of leak occurring (5x10-6y-1)7 [4] All materials storage and handling on-site will be controlled by SOP.

2





o Assessment of Risks

A Risk Register has been prepared listing the risks to be assessed (Table 7). Minor risks (risk score ≤ 2) have been excluded at this stage. The environmental risks have been ranked according to their risk score.

Table 7 Risk Register Ranked by Risk Scores

Risk ID

Description Severity Rating

Occurrence Rating

Risk Score

1 Large volume cell culture spill 1 3 3

4 500 L seed bioreactor - Wrong transfer panel jumper used

1 3 3

5 500 L seed bioreactor - Transfer started when jumper is being released

1 3 3

6 500 L seed bioreactor - Incorrectly made connection

1 3 3

7 500 L seed bioreactor - Overfilling 1 3 3

8 Production Bioreactor Chain - Large volume spill

1 3 3

9 Purification chromatography skids and columns - Overpressurisation

1 3 3

10 Large Scale Media Preparation - Overfilling bags

1 3 3

12 CIP - Inadequate alkaline concentration/temperature on inactivation part of cycle for BL1 contaminated equipment

1 3 3




13 Biowaste inactivation - Biowaste header becomes blocked

1 3 3

14 Reduced Ion Water/DI/PUR - Ozone destruct filter failure

1 3 3

A risk matrix is provided below to allow the risks to be easily displayed and prioritised. The colour codes shown are as follows:

• Red – high-level risks requiring priority attention;

• Yellow – medium-level risks requiring action, but not as critical as red-coded risks;

• Green (light and dark) – low-level risks requiring continuing awareness and monitoring on a regular basis.




Risk Matrix

Very high 5

High 4

Medium 3

Risk ID: 1, 4, 5, 6, 7,8, 9, 10, 12, 13, 14

Low 2

Occurrence

Very low 1

Trivial Minor Moderate Major Massive

1 2 3 4 5 Severity

o Risk Prevention, Mitigation and Management

Risk Management Responsibility The site organisational structure provides for the resources and the authority to ensure the completion of all necessary actions. All personnel whose work directly or indirectly affects the site environment receive suitable and sufficient training to enable them to discharge their responsibilities.




The Environment, Health and Safety (EHS) Lead has primary responsibility for the

Environmental Management System (EMS) and the Environmental Management Plan (EMP). The site will seek accreditation for a system complying with the requirements of ISO 14001.

Other team leaders have the responsibility to ensure appropriate procedures, training and recording for operational requirements are in place and that this training includes awareness of environmental protection.

The EHS Lead will support this training programme directly and via environmental audit. The EHS Lead will also manage the investigation and corrective action process.

The site Environmental Management Group (EMG) will meet on a regular basis to review the EMS implementation. This group will be chaired by the site leader (or designee) and will include the EHS Lead and the team leaders with responsibility for production, energy usage, technical and engineering services, and human resources. The EMG will manage the progress of the EMP and specifically the timely achievement of the Environmental Objectives and Targets. It may modify or add to this Schedule in response to any changed circumstances.

The Site Leader will have overall responsibility for site safety and supervision and he will delegate the implementation of these responsibilities to all his staff. A Site Support Team will be in place to ensure these responsibilities will be implemented in full. Under the leadership of the Engineering Team Leader and EHS Lead, the site will have a flat structure, with all colleagues dedicated to ensuring the EHS Policy for the site will be implemented through a well defined EHS Management System.

The Production/Manufacturing Team Leader, Quality Operations Team Leader and the Technical Services Team Leader will have overall responsibility as the key users of the GMM on-site.

Accident Prevention Pfizer recognises that appropriate Environmental Accident Prevention (EAP) is the first line in assuring the protection of the site environment. This is seen as separate to the necessity for maintaining an Emergency Response Plan (ERP). The ERP will support EAP by containing the extent of any incident and by limiting the scale of any potential effects.

Emergency Response The Emergency Response Plan (ERP) is designed to minimise the negative impact of any incident on Safety, Health and the Environment. Some incidents may have a general impact. Some incidents may have an environmental impact without any danger to safety or health. The measures taken to contain and limit environmental incidents require and will be given a level of awareness in training equivalent to that for incidents having an effect on health and safety.




The ERP contains all the elements considered necessary to manage and control the effects of any incident which causes or has the potential to cause any negative impact on the Environment. The ERP opens with a policy document which describes the aims and intent of the plan. This is followed by a more detailed outline of the objectives and by a description the plan.

The main elements of the plan are summarised as follows:

Organisation

The emergency response organisation comprises those whose duty is front line emergency response (ER) and those who will have a coordinating and directive role when assembled in the emergency control centre (ECC).

The ER is led by an emergency controller (EC). The EC implements the specific action plan, as required. This includes immediate contact with all ECC colleagues. The ECC is directed by the site team leader (or deputy). The ECC is supported by all other team leaders, who have various, pre-designated functions and duties.

Training on all aspects of the plan is driven by the EHS Lead. This includes training for specific duties, desk top exercises and drills. All ERP exercises and drills will be documented and reviewed.

General Action Plan

The general action plan outlines the responses and actions required of all site colleagues during a site emergency. It describes the duties and responsibilities of the ER group and of the ECC group.

It describes the means of and approved methods for communication during an emergency. It designates the requirements for evacuation / internal assembly and accounting for colleagues.

Specific Action Plans

Specific action plans cover the ER required by specific incident e.g. spillage, fire. They include a guide to category of incident: whether “minor”, “serious”, or “major”.




Emergency and Alarm Systems

The site is equipped with both a fire alarm system and an emergency suppression systems. The site is also equipped with local fire extinguisher points, with extinguishing media suitable for the materials handled in the area. Upon activation of the fire alarm, colleagues exit via evacuation exits, and assemble at their designated assembly points.

Off-Site and Third Party Communication/Interaction

This describes the requirements and modes of communication with a number of stakeholders, as follows:

• Local Community / Neighbouring Sites

• Statutory / Regulatory Authorities

• Cork Joint Emergency Plan / Emergency Services

• Pfizer Corporate

• Public Relations Handling

Post Incident Review

All incidents which have caused or have had the potential to cause serious injury, environmental damage or economic loss are judged to be “serious incidents”. All serious incidents are investigated according to an approved procedure to determine cause, propose remedial and preventive action, implement and confirm completion of that action.

Plan Maintenance

The ERP is reviewed annually for completeness and applicability. It is updated if required. It may also be reviewed more frequently in response to the findings of a serious incident investigation or other change.




o Financial Liability

The financial liability of the risks is assessed based on the probability of the scenario occurring and the cost implications should the scenario occur. In this assessment the worst-case scenario is considered, therefore the maximum of each range of costs is used. Table 11 below outlines the financial output for the worst-case scenario. Minor risks (risk score ≤ 2) have again been excluded at this stage.




Table 8 Worst-case Financial Model

Risk ID

Occurrence Rating

Likelihood of

Occurrence Range (%)

Worst-case Probability

(%)

Severity Rating

Cost Range

(€)

Worst-case

Severity (€)

Worst-case

Scenario (€)

1 3 10-20 20 1 0-1,000 1,000 200

4 3 10-20 20 1 0-1,000 1,000 200

5 3 10-20 20 1 0-1,000 1,000 200

6 3 10-20 20 1 0-1,000 1,000 200

7 3 10-20 20 1 0-1,000 1,000 200

8 3 10-20 20 1 0-1,000 1,000 200

9 3 10-20 20 1 0-1,000 1,000 200

10 3 10-20 20 1 0-1,000 1,000 200

12 3 10-20 20 1 0-1,000 1,000 200

13 3 10-20 20 1 0-1,000 1,000 200

14 3 10-20 20 1 0-1,000 1,000 200

Total 2,200

o Review of ELRA

It is proposed to review this Risk Assessment, Risk Management Plan and Financial Provision within a three year period to reflect the following:




• Review the risk register based on the addition and deletion of risks;

• Verify the implementation of the Risk Management Plan;

• Review financial provisions to ensure environmental liabilities covered;

• Confirmation that financial instruments continue to effectively provide financial provision.




• FINANCIAL PROVISION As with any industrial process, during abnormal operations it is possible for environmental liabilities to occur. The worst-case financial model quantifies the unknown environmental liability at the site as €2,200. In general, the risk associated with abnormal activities on-site is considered to be acceptable and therefore the environmental liability costs would be covered by Pfizer’s public liability insurance, the limit of indemnity of which is US$10,000,000 for any one event.

• REFERENCES [1] Environmental Protection Agency (2006) Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and

Financial Provision EPA Wexford

[2] AWN Consulting Ltd (2007) Environmental Impact Statement In respect of a Monoclonal Antibodies Small Scale Facility providing a phase III clinical trial and initial product launch facility to manufacture, purify, formulate and bulk fill mammalian cell culture derived proteins, and including a production area, warehouse, laboratory/administration area, and central utility plant.

[3] Pfizer Mabs SSF Process Hazard Review

[4] Committee for Prevention of Disasters (1999) Guidelines for Quantitative Risk Assessment CPR 18E First Edition




M ATTACHMENT VII – Decommissioning Management Plan


MAbs SSF

Decommissioning Management Plan



MAbs SSF

Decommissioning Management Plan

May 2009

This report takes into account the

particular instructions and requirements of our client. It is not intended for and should not be relied upon by any third party and no responsibility is undertaken to any third party

Arup Consulting Engineers 15 Oliver Plunkett Street, Cork Tel +353 21 4277670 Fax +353 21 4272345 www.arup.ie Job number C2054.40




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File reference Document title Decommissioning Management Plan

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Name Dan Garvey Ria Lyden Eoghan Lynch

Draft 1 27/03/09

Signature

Filename Decommissioning Management Plan_issue.doc

Description Issue 1


Name Dan Garvey Ria Lyden Eoghan Lynch

Issue 19/05/09

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Page i Arup Consulting Engineers

Contents

Page Executive Summary Error! Bookmark not defined.

1 INTRODUCTION..................................................................................................1 2 BACKGROUND TO PFIZER MABS SSF...........................................................1 3 SITE EVALUATION ............................................................................................2

3.1 Site Location and General Context 2 3.2 Site Environmental Sensitivity Classification 2 3.3 Site History and Operational History Including Full Details of Site Processes 2 3.4 Site Investigations and Information Available Regarding the Environmental Performance of the Site 3 3.5 Site Facilities and Buildings 3

4 CLOSURE CONSIDERATIONS..........................................................................6 4.1 Assessment of Potential Risks 6 4.2 Criteria for Successful Closure 6 4.3 Scope of Decommissioning Management Plan 7 4.4 Clean or Non-Clean Closure Declaration 7 4.5 Plant and Equipment Cleaning, Disposal or Recovery Requirements 7 4.6 Waste Disposal or Recovery 10

5 DECOMMISSIONING MANAGEMENT PLAN COSTING ...........................10 5.1 Plant Decommissioning and Waste Disposal Costs 10 5.2 Monitoring and Assessment During Decommissioning 10 5.3 Facility Security and Staffing 10 5.4 Internal Resource Requirements 11 5.5 Total Cost 11 5.6 Funding of DMP 11

6 DMP UPDATE AND REVIEW ..........................................................................12 6.1 Proposed Frequency of Review 12 6.2 Proposed Scope of Review 12

7 DMP IMPLEMENTATION................................................................................12 7.1 EPA Notification 12 7.2 Local Authority Notification 12

8 DMP VALIDATION............................................................................................12 8.1 Closure Validation Audit 12 8.2 Closure Validation Audit Report 12 8.3 Closure Validation Certificate 12

9 REFERENCES ....................................................................................................13

Figures Figure 1 Site Plan (not to scale) Appendices

APPENDIX A SCREENING AND OPERATIONAL RISK ASSESSMENT



Page ii Arup Consulting Engineers

Executive Summary The Pfizer Monoclonal Antibodies (MAbs) Small Scale Facility (SSF), known as Pfizer MAbs SSF, is currently under construction at Shanbally, Ringaskiddy, County Cork. The Facility will be a phase III clinical trial and initial product launch facility to manufacture, purify, formulate and bulk fill mammalian cell culture derived proteins These will form the Active Pharmaceutical Ingredient (API) in products intended for human use. The facility will include seed bioreactors, two 2500 litre production bioreactors, and cell culture harvest equipment. In addition, the facility will include a warehouse in which the raw material and finished goods will be stored, and quality control laboratories and administration offices.

The Pfizer MAbs SSF is located in an approximately four hectare area at the south west of a larger 12 hectare site. The site was formerly occupied by the ADM plant, which has been demolished. Refer to Figure 1.

This Decommissioning Management Plan has been prepared to comply with Condition 10 of Pfizer Biotechnology Ireland’s IPPC licence – P0894-01. In particular, the Plan has been developed to satisfy the following sub-clauses 10.2 and 10.3 of Condition 10:

‘10.2 Decommissioning Management Plan (DMP)

10.2.1 The licensee shall prepare, to the satisfaction of the Agency, a fully detailed and costed plan for the decommissioning or closure of the site or part thereof. This plan shall be submitted to the Agency for agreement in advance of the commencement of the activity.

10.2.2 The plan shall be reviewed annually and proposed amendments thereto notified to the Agency for agreement as part of the AER. No amendments may be implemented without the agreement of the Agency.

10.2.3 The licensee shall have regard to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Decommissioning Management Plans and Financial Provision when implementing Condition 10.2.1 above.

‘10.3 The Decommissioning Management Plan shall include, as a minimum, the following:

(i) a scope statement for the plan;

(ii) the criteria that define the successful decommissioning of the activity or part thereof, which ensures minimum impact on the environment;

(iii) a programme to achieve the stated criteria;

(iv) where relevant, a test programme to demonstrate the successful implementation of the decommissioning plan; and

(v) details of the costings for the plan and the financial provisions to underwrite those costs.’

In accordance with the EPA Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision (EPA 2006), the risk classification tool was used, and the Screening and Operational Risk Assessment is included as Appendix A to this report. The Assessment found that the site has a risk category of 2, and therefore a residuals management plan is not required.

Pfizer Global Environmental Health and Safety has established procedures in relation to Acquisition and Divesture of Real Property. These procedures will apply at the Pfizer MAbs SSF site. Pfizer Biotechnology Ireland’s responsibility is to ensure that any business divesture involving real property is preceded by an environmental due-diligence investigation to assess and quantify potential environmental liabilities associated with the transaction.



Page iii Arup Consulting Engineers

Pfizer Biotechnology Ireland has no current plans to decommission part, or all of the site. Two possible scenarios in the event of a shutdown of the facility were considered:

• Do-nothing

• Do-something.

The do-nothing scenario describes the situation of potential risks if the facility were vacated without implementing the DMP. The do-something scenario describes the potential risks of the DMP is implemented.

It should be noted that the do-nothing scenario is not consistent with the divesture policy of Pfizer, and therefore Pfizer Biotechnology Ireland. Consequently, Pfizer Biotechnology Ireland propose to implement the do-something scenario, and therefore the DMP.

The scope of this Plan addresses the key issues that would occur in an orderly shutdown of all the site activities on a phased basis over an estimated time period of three to six months. Clean closure is envisaged for the site. The basis of the Plan is to ensure that, on completion of the Plan, the facility would be in a suitable state for future industrial use and its condition would not pose a risk to public health and safety or the environment.

It would not be intended to remove all structures and systems from the site. In general, most of the equipment is in skid form, and easily removable. Specialist equipment would be distributed to sister plants in the event of a shut down.

Pfizer Biotechnology Ireland intends to utilise existing staff resources to form a team to manage and execute the plan, supplemented where appropriate by outside resources. This DMP team would be responsible for managing and executing the complete plan. Contractors required for cleaning, waste disposal, incineration or recycling activities would be fully approved and licensed.

It is estimated that the duration of decommissioning and cleaning would be three to six months. Environmental monitoring would continue while the Plan is in operation and for a period following the completion of the Plan to be determined by the Environmental Protection Agency (EPA) and/or Cork County Council. The EPA and the County Council would be informed of the results of the monitoring programme and of the status of the Plan.

Particular actions are required for specific areas of the facility as part of the DMP. In general, care and attention would be given during the implementation of the Plan to ensure that the potential risks associated with the Plan are avoided. In the event of a spillage, leak or fire during decommissioning, Pfizer Biotechnology Ireland’s Emergency Response Plan would be fully implemented in order to minimise the risk to health and the environment.

The costs associated with decommissioning are generally related to the disposal and recycling of equipment and the use of external resources to implement the DMP. In certain instances, costs will be recouped through the sale of equipment and materials.

It is expected that external resources will be required in order to implement the DMP in full. A list of these resources and associated costs is shown in Table 1 overleaf.

The facility is also subject to a Consent for the first time use of a premises for the contained use of a Class 1 GMM activity. All activities associated with the implementation of the DMP will be carried out in full compliance with the conditions of this Consent.



Page iv Arup Consulting Engineers

Table 1 Decommissioning and Waste Disposal Costs

Item Estimated Cost (€)

transportation of process equipment off-site 200,000

transportation of other goods 65,000

inactivation and cleaning 40,000

incineration 33,000

recycling 10,000

disposal costs 33,000

civil, structural, mechanical, electrical and instrumentation contractors 600,000

subtotal 981,000

contingency (25%) 245,250

Total 1,226,250

It is estimated that a cost of approximately €1.23 million would be incurred to decommission the site, including external resources costs.

It is estimated that a cost of €53,000 would be incurred in monitoring and assessment during the decommissioning phase.

A number of staff members would be required to remain on site for a period of three to six months to successfully implement the DMP.

These are estimated as follows:

Management 2

Security 4

Laboratory 3

Administration 2

Other Staff 2

The cost of continuing to employ these staff members is expected to be in the region of €460,000.

The total cost associated with executing the DMP at the Pfizer MAbs SSF site is estimated to be in the region of €1.75 million. In addition, to maintain ongoing security, safety and an environmental monitoring presence at the site would cost approximately €46,000 per annum.

Pfizer Biotechnology Ireland MAbs SSFDecommissioning Management Plan


Arup Consulting EngineersIssue 19 May 2009

• Introduction The first step in the preparation of a Decommissioning Management Plan or an Environmental Liabilities Risk Assessment, recommended in the EPA’s Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision, is to identify the risk category of the facility. The screening and operational risk assessment for the Pfizer Monoclonal Antibodies (MAbs) Small Scale Facility (SSF) has been undertaken in accordance with the methodology outlined in the guidance document. This assessment is included as Appendix A to this Plan.

The screening and operational risk assessment indicated the requirement for a closure plan.

This Decommissioning Management Plan (DMP) was prepared to comply with Condition 10 of Pfizer Biotechnology Ireland’s IPPC licence – P0894-01. In particular, the Plan has been developed to satisfy the following sub-clauses 10.2 and 10.3 of Condition 10:

‘10.2 Decommissioning Management Plan (DMP)

10.2.1 The licensee shall prepare, to the satisfaction of the Agency, a fully detailed and costed plan for the decommissioning or closure of the site or part thereof. This plan shall be submitted to the Agency for agreement in advance of the commencement of the activity.

10.2.2 The plan shall be reviewed annually and proposed amendments thereto notified to the Agency for agreement as part of the AER. No amendments may be implemented without the agreement of the Agency.

10.2.3 The licensee shall have regard to the Environmental Protection Agency Guidance on Environmental Liability Risk Assessment, Decommissioning Management Plans and Financial Provision when implementing Condition 10.2.1 above.

‘10.3 The Decommissioning Management Plan shall include, as a minimum, the following:

(i) a scope statement for the plan;

(ii) the criteria that define the successful decommissioning of the activity or part thereof, which ensures minimum impact on the environment;

(vi) a programme to achieve the stated criteria;

(vii) where relevant, a test programme to demonstrate the successful implementation of the decommissioning plan; and

(viii) details of the costings for the plan and the financial provisions to underwrite those costs.’

This DMP incorporates the EPA requirements for a closure plan, as set out in Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision (EPA 2006) and has been prepared on the basis that there will be clean closure with no outstanding environmental issues following closure.

The facility is also subject to a Consent for the first time use of a premises for the contained use of a Class 1 GMM activity. All activities associated with the implementation of the DMP will be carried out in full compliance with the conditions of this Consent.

• Background to Pfizer MAbs SSF The Pfizer MAbs SSF is currently under construction at Shanbally, Ringaskiddy, County Cork. The Facility will be a phase III clinical trial and initial product launch facility to manufacture, purify, formulate and bulk fill mammalian cell culture derived proteins. The




facility will include 5,000 litres of bioreactor capacity that will be capable of concurrent mono-product production. In addition, the facility will include a warehouse in which the raw material and finished goods will be stored, and quality control laboratories and administration offices.

The facility will operate under an Integrated Pollution Prevention and Control (IPPC) licence and a Genetically Modified Micro-organism (GMM) licence.

• Site Evaluation o Site Location and General Context

The Pfizer MAbs SSF site is located at Ballintaggart, Shanbally, adjacent to the Pfizer Ireland Pharmaceuticals active pharmaceutical ingredients (API) plant at Ringaskiddy, in County Cork. The facility occupies the South-eastern part of the 12 ha (30 acre) site of the former Archer Daniels Midland Company (ADM) manufacturing plant at Shanbally. Refer to Figure 1.

The site is bounded to the west by the Rafeen Creek Golf Course and the Pfizer sports facilities, and to the north by Monkstown Creek. Shanbally village lies to the west of the sports facilities and the town of Monkstown lies to the north of Monkstown Creek. To the south, across the N28 National Primary Route is industrial zoned land, currently in use for pasture. The Centocor Biologics plant lies to the southeast and there are a number of other pharmaceutical manufacturing and other industrial plants in the general area. The Port of Cork has port facilities to the east of the Pfizer Ireland Pharmaceuticals API plant.

o Site Environmental Sensitivity Classification

As described in detail in the screening and operational risk assessment, the site has a ‘moderate’ environmental attribute score, and therefore an environmental sensitivity classification of 2, in accordance with Table 2.3 of the EPA guidance document.

o Site History and Operational History Including Full Details of Site Processes

The site of the Pfizer MAbs SSF was formerly occupied by the ADM plant. The Pfizer MAbs SSF buildings, facilities and infrastructure are located on the part of the former ADM plant which comprised mainly landscaped and paved areas.

The ADM facility was used to manufacture a range of citric and gluconic acid products primarily for use in the food and soft drinks industry. It had been in operation since the early 1970s and was acquired by ADM in 1990. The facility closed in 2005 and the site and remaining areas of the ADM facility were acquired by Pfizer Inc. in 2007. No processing, storage or manufacturing related activities took place on the portion of the former ADM site on which the Pfizer MAbs SSF is being built. This portion of the site comprised mostly landscaped undeveloped areas, with the remainder being paved.

Demolition of the ADM facility was completed in June 2007. Most of infrastructure present on the portion of the former ADM site, on which the Pfizer MAbs SSF is being built, was removed prior to commencement of construction. This included the main access road to the former ADM facility, a security station/guardhouse and minor landscaping features.

Some decommissioned site infrastructure was retained, namely the ADM waste water treatment plant, two storage tanks and pipe-racks in the northern part of site, and an engineering work-shop / stores building and paved area which is centrally located on the site.




The IPC Licence for the former ADM facility (P0053-01) was surrendered in October 2007 following the satisfactory completion of work defined by the EPA in the Exit Audit Report, issued 12th September 2007.

o Site Investigations and Information Available Regarding the Environmental Performance of the Site

As the Pfizer MAbs SSF has not commenced operation, this information is not available.

o Site Facilities and Buildings

Overview The Pfizer MAbs SSF main building will comprise a three storey manufacturing wing approximately 7,625m2 in area with a penthouse plant room at the third floor level; a two storey Administration/Laboratory wing (2570m2); and a Warehouse wing (1210m2). An external utility yard area will also be provided to the west of the main building. A detached single story Security Station/Guard House (55m2) will be constructed to the south.

The site will be serviced by a new internal ring road, and staff and visitor parking.

The MAbs SSF will comprise five main areas:

• Production area, • Warehouse, • Laboratory/office area, • Utility area (or Central Utility Plant - CUP), • Plant mechanical area.

Production Area Processes The production area processes will include cell culture, purification, and process support functions. Cell culture will include media preparation, inoculum preparation, seed bioreactors, production bioreactors, and recovery / harvest. Purification will include buffer preparation, buffer hold, purification, formulation and bulk fill. Process support areas will include the dispensary and glasswash.

The MAbs SSF will be based on production at a measured concentration of 1.0 to 3.0g/litre of Active Pharmaceutical Ingredient, 50% to 65% overall yield, and 38 batches per year.

Cell culture will comprise two 2,500 L production bioreactors and one seed bioreactor train. The seed train will employ a 500 L bioreactor and a series of Wave Biotech culture bags. The purification train is divided into pre-viral and post-viral suites. The bulk-purified, formulated protein will be filled into bags, and either frozen and stored at -20 to -40 degrees Celsius, or stored at 2 to 8 degrees Celsius. A weigh and dispense area will dispense reagents for the media preparation, buffer preparation and purification areas.

Warehouse Raw materials and finished goods will be stored in the warehouse. Storage racks will be provided for raw materials, consumables and other components. Separate cold rooms, fridges and freezers will be provided for storage of raw material and finished products. Cell Bank storage will also be provided in the warehouse.

A material sampling will be provided in the warehouse for material inspection and sampling. Separate dispensing areas will be provided for handling buffer and media solutions at large volumes. A kit staging area will also be provided.

Spare parts will be stored in the maintenance area. Fork trucks, pallet trucks and drum handling equipment will be included. The majority of raw materials will be received in drums. There will be no provision to handle large bags in the facility. Small bags will be manually handled in the small weigh/dispense area.




Laboratory / Office The laboratories will be situated on the second floor of the Laboratory/Administration area. These will house the laboratory facilities for two separate functions, Quality Control (QC) Laboratories and Technical Services Laboratory. The QC laboratory will carry out the following functions:

• Raw Material Testing • In Process Control Testing • Final Drug Substance Testing • Microbiological Testing • Drug Product Testing of products manufactured at the Pfizer Dublin site. The QC laboratory will contain a range of analytical equipment to enable the requisite range of testing to be carried out on site. The separate laboratories and support areas and their functions within Quality Control will be as follows:

• General laboratory where analysis including chromatography, capillary electrophoresis, imaged capillary isoelectric focussing, spectrophotometry, total organic carbon and wet chemical analysis on all samples will be conducted.

• Two microbiology laboratories where the main testing will be bioburden testing, microbiological identifications, endotoxin testing , water and environmental monitoring.

• Stability laboratory which contains a walk-in cold room and a walk-in refrigerator, and freezers to store samples for stability testing according to ICH guidelines.

Support rooms such as wash up area, sample receipt, autoclave and steriliser room, chemical store, document store, meeting room and offices. These will be shared with Technical Services where necessary.

Technical Services Laboratory The Technical Services Laboratory will carry out the following functions:

• Laboratory process qualification (LPQ) work on new products • Process optimisation work • Plant support. The Technical Services Laboratory will be divided into an Upstream and Downstream Processing areas. The Upstream area will house wave reactors and laboratory scale bioreactors to mimic the upstream plant processes. These will be used for LPQ work, raw material evaluations, support of plant trials and plant process investigations and process validation studies. The Downstream area will house chromatography and filtration equipment to mimic the downstream plant processes and will be used for similar activities, studies and investigations as the Upstream area.

The QC and Technical Services Laboratories will be fitted with fume hoods, biosafety cabinets, refrigerators, freezers, incubators and will be supplied with high quality water, gases and other services and utilities for a fully functioning laboratory.

Utility Area or Central Utility Plant (CUP) The CUP internal area will contain the Water-for-Injection (WFI) generation and storage, Reduced Ion Water (RIW) generation and storage, clean steam generation, biowaste inactivation, process waste water pre-treatment (equalisation, neutralisation), plant steam boilers, HVAC chillers, process chillers, the compressed air system, CIP systems and temperature control modules associated with the process vessels, i.e. jacket services.

Externally located equipment will include cooling towers and pumps, utility water tank and pumps, bulk gas storage (CO2 and O2), chemical treatment systems, laboratory gases in bottles, emergency generator with integral fuel oil storage tank and rotary UPS system.




Plant Mechanical Area The plant mechanical area will hold the Air Handling units and HVAC hot water system.

Inventory of Buildings, Raw Materials and Wastes The site buildings are described in Section 3.5.1 above.

The inventory of raw materials and wastes is provided in Tables G1(i), G1(ii), H1(i) and H1(ii) of the IPPC licence application.

Storage Areas, Testing of Bunds and Services The facility is designed to produce generic mammalian cell culture derived proteins for use in products intended for human use. The final bulk product will be stored in 20 litre disposable bags (containing 16.6 litre), stored at temperatures ranging from 5, -20, -40, -50 or -70 degrees Celsius. A maximum of 680 disposable bags will be able to be stored at any one time in the warehouse product freezers.

Process chemicals will be received and release tested by Quality Control (QC) prior to use. These will be stored in the Warehouse or, to a limited extent, in a secure bunded storage location (Chemstore or similar) in the west utility yard area.

Raw materials will be received in drums, cylinders, bottles and shipping totes. Raw materials will not be delivered by tank truck, with the exception of bulk gases. Oxygen and carbon dioxide will be supplied from leased central supply storage vessels located in the utility yard.

Due to the nature of the process, which uses mammalian cells to produce drug molecules, toxic chemicals are not used, as these would kill or damage the mammalian cells. Corrosive cleaning chemicals such as sodium hydroxide will be used to clean equipment. These chemicals will typically be supplied in rigid re-usable intermediate bulk containers (IBCs).

As part of the commissioning of the project, bunds and underground services will be tested as required. This is scheduled to occur in 2009, prior to commencement of the activity. The records of testing will be made available for review by the EPA.

Details of Waste Shipments and Waste Contractors The details of waste shipments and waste contractors have not yet been finalised. This information will be provided to the EPA when available.




• Closure Considerations o Assessment of Potential Risks

Introduction Pfizer Biotechnology Ireland has no current plans to decommission the MAbs SSF site. Two possible scenarios in the event of a shutdown of the facility are described below.

• do-nothing • do-something.

The do-nothing scenario describes the situation of potential risks if the facility was vacated without implementing the DMP. The do-something scenario describes the potential risks if the plan was implemented.

Do-Nothing Scenario In the event of a shutdown of the plant, the following risks are associated with the do-nothing scenario:

• Leaks from raw materials left on site resulting in contamination of the groundwater and/or impairment of air quality

• Vandalism of the site resulting in emissions to ground and/or air, or causing a fire.

The above risks are probable if the Decommissioning Management Plan (DMP) is not implemented.

Do-Something Scenario A number of risks are associated with the implementation of the DMP. They can be assessed as follows:

• During the removal of raw materials off-site, there is a potential that a leak could occur, resulting in contamination of the groundwater and/or emissions of smoke or products of incomplete combustion.

• While removing materials that cannot be returned, recycled or sold-on from the site, there is the potential for inappropriate disposal, resulting in the generation of litter and/or pollution.

• Once vacated, there is the potential for a break-in at the facility that could result in a fire or vandalism of the building or equipment.

The above risks can be greatly reduced, when the DMP is implemented.

o Criteria for Successful Closure

The principal criteria against which successful closure will be gauged are as follows:

• All buildings and facilities will be cleaned and secured from unauthorised access. • There will be no constraints on future land due to residual contamination or structures. • Materials will be treated in such a manner that:

- equipment or clean materials can be resold or sold for scrap;

- clean rubble can be removed offsite and reused where possible as fill, or will be landfilled;

- hazardous materials will be disposed of using authorised hazardous waste contractors.




The overall objective is to achieve clean closure of the site with no residual liabilities or constraints.

o Scope of Decommissioning Management Plan

The scope of this plan addresses the key issues, which would occur in an orderly shutdown of all the site activities on a phased basis over an estimated time period of 3-6 months.

The scope of the plan includes the following major activities:

• cessation of all production activities, • setting up a management structure to oversee the DMP, • removal of all remaining raw materials, intermediates and final products from the site, • inactivation of all remaining product-contact equipment and disposables, • decommissioning and cleaning of all equipment and buildings, • shutting down of all abatement and utility systems, • completion of a report on all aspects of the site within 60 days of completion of plan

activities, and • maintaining an on-going security and monitoring service. The basis of the plan is to ensure that, upon completion of the plan, the facility would be in a suitable state for future industrial use and its condition would not pose a risk to public health and safety or the environment.

It is not intended to remove all structures or systems from the site. In general, most of the equipment is in skid form and is easily removable. Specialist equipment will be distributed to sister plants in the event of a shut down.

Pfizer intends to utilise existing staff resources to form a team to manage and execute the plan, supplemented where appropriate by outside resources. This Closure Management Team would be responsible for managing and executing the complete DMP. Outside contractors required for cleaning, waste disposal, incineration or recycling activities would be fully approved and licensed.

It is estimated that the duration of decommissioning and cleaning would be 3 to 6 months. Environmental monitoring would continue while the plan is in operation and for a period following the completion of the plan to be determined by the EPA and/or local authority. The Environmental Protection Agency (EPA) and the local authority would be informed of the results of the monitoring programme and of the status of the plan.

o Clean or Non-Clean Closure Declaration

A Clean Closure is expected. Upon cessation of operations and subsequent decommissioning at the facility, there will be no remaining environmental liabilities.

o Plant and Equipment Cleaning, Disposal or Recovery Requirements

Particular actions are listed below for specific areas of the facility as part of the DMP. In general, care and attention will be given during the implementation of the plan to ensure that the potential risks associated with the plan are avoided. In the event of a spillage, leak or fire during decommissioning, Pfizer’s Emergency Response Plan would be fully implemented in order to minimise the risk to health and the environment.

Storage Areas Storage of materials is described in Section 3.5.9 above.

The DMP for all storage areas and the warehouse would consist of the following actions:

• Cancellation of all orders for incoming materials to the site.




• Negotiation with relevant suppliers to return unused materials to supplier. • Clean the storage areas. Standard operating procedures, which are being developed for

the facility, would be sufficient for these operations. Specific procedures would be developed, if required. The state of cleanliness would be verified either analytically or through a visual inspection.

Production Areas The production facilities are described in Section 3.5.2 above.

The DMP for the production area would consist of the following actions:

• Cessation of all production other than completion of work in progress. • Removal of all products to the relevant area of the warehouse for transfer to other

facilities or for disposal if necessary. • Cleaning and inactivation of all process vessels and any other equipment with product

contact. Standard operating procedures, which are being developed for the facility, would be sufficient for these operations. Specific procedures would be developed, if required. The state of cleanliness would be verified either analytically or through a visual inspection.

• Shutting of all supply lines to the building, cleaning out all pipework through regular cleaning methods.

• Shutting off unnecessary services to the building. Heating and ventilation capability would be maintained.

• Removal and destruction by incineration of all filters or any ducting or enclosure that would have product or other GMM material contact.

• Maintenance of key instrumentation and computer systems required for on-going monitoring of the status of the equipment, the remaining instrumentation to be disconnected and rendered safe.

• Cleaning of all floor drains, sumps and bunded areas. • Specialist equipment, once cleaned, to be sent to sister Pfizer facility for use in similar

or other processes.

Laboratory Areas The laboratories have been described in Sections 3.5.4 and 3.5.5.

The DMP for laboratory areas would consist of the following actions:

• Completion of all necessary analytical work on production in progress and all final products before removal from site.

• Return to vendor or sell on all unopened and in-date laboratory chemicals. • Removal of all opened chemical containers and out of date chemicals for recycling or for

disposal by a licensed contractor. • Cleaning of laboratory instruments. • Cleaning of all glassware, storage areas, waste systems and any other equipment or

systems. • Shutting down of all computer systems other than those deemed necessary for ongoing

monitoring of the area. • Transfer of specialised equipment to sister plant or sale to similar facility. Recycle of

obsolete equipment, if possible, otherwise disposal by licensed contractor.

Utilities and Mechanical Area Plant utilities have been described in Section 3.5.6.

The DMP for the utilities areas would consist of shutting down of the following systems on a phased basis, depending on plant status and requirements:

Boiler




It is likely that the boilers would be required during decommissioning and subsequently for ongoing heating requirements. If not required, they would be shut down and disconnected from the steam distribution system. The boilers would be cleared of residues and the fuel lines cleaned and blanked off. Condensate systems would be drained and cleaned and left in a safe state.

Oxygen, Carbon Dioxide and Laboratory Gases

These units would be shut down and disconnected at an appropriate time. The oxygen and carbon dioxide storage tanks would be emptied and returned to the distributor.

Removal of any associated chemicals, oils or any other materials used in the utilities area for redistribution, return to vendor or disposal, if required.

The water supply system would be maintained due to the needs for fire protection and sanitary services.

Waste Oils, Diesel and Hazardous Waste

Waste oils, and hazardous waste will be removed from site and disposed of to a suitably licensed facility. The diesel tanks would be emptied and any diesel sold back to the supplier.

Effluent Equalisation and Neutralisation Systems

The effluent equalisation and neutralisation systems would be shutdown and disconnected at the appropriate time. The plant and associated pipework would be cleaned using normal cleaning methods.

Offices, Administration, Reception and Security The Administration area has been described in Section 3.5.4.

The DMP for the Administration area would include the following actions:

• Removal of administration equipment for distribution to sister facility or sale to interested party, where possible, otherwise for disposal by a licensed contractor.

• The maintenance of a security presence on site on a 24-hour basis for ongoing monitoring of the site from a safety, fire prevention and environmental perspective.

• Removal of canteen equipment for distribution to sister facility or sale to interested party, where possible, otherwise for disposal by a licensed contractor.

Other Areas The following other actions would be required to ensure the implementation of the DMP on a site-wide basis.

• Cessation of any construction project work on site so that the site is left in a safe and orderly condition. Contractors will be required to decommission any construction compounds and remove all construction equipment, construction materials and waste, storage units and temporary offices from the site at the completion of construction projects.

• Disbandment of contract personnel, facilities and equipment. • Termination of all non-essential maintenance and other contracts. • Removal from site of any temporary offices or storage areas. • Rationalisation of the site electricity supply. This would involve removing transformers

from service, allowing remaining site operations to run from one transformer. All new transformers are resin cast, and contain no oils.

• Testing of soils and groundwater at the time of decommissioning would be performed and remediation carried out, if necessary.

• Retention of all necessary fire alarms and fire protection systems. • Retention of standard security patrols, video monitoring and defined site access

procedures. • Cleaning of all petrol/oil interceptors in accordance with normal procedures.




• Removal of all items that may contain mercury (for example fluorescent lights) or any other controlled compounds for recycling or disposal if necessary.

o Waste Disposal or Recovery

During closure the disposal routes for hazardous wastes will be similar to current disposal routes for hazardous wastes, namely recovery off-site, energy recovery off-site and incineration off-site. Disposal will be by authorised hazardous waste contractors. Hazardous wastes will comprise those wastes listed in Tables H1(i) and H1(ii) of the IPPC licence application.

Non hazardous waste will be recycled, where possible. If recycling is not feasible it will be disposed of off site by approved contractors.

• Decommissioning Management Plan Costing The expected costs associated with site closure are outlined in this section.

o Plant Decommissioning and Waste Disposal Costs

Decommissioning and Waste Disposal Costs

Item Estimated Cost (€)

transportation of process equipment off site 200,000

transportation of other goods 65,000

inactivation and cleaning 40,000

incineration 33,000

recycling 10,000

disposal costs 33,000

civil, structural, mechanical, electrical and instrumentation contractors 600,000

subtotal 981,000

contingency (25%) 245,250

Total 1,226,250

It is estimated that a cost of approximately €1.23 million would be incurred to decommission the site, including external resource costs.

o Monitoring and Assessment During Decommissioning

It is estimated that a cost of €53,000 would be incurred during monitoring specific to the decommissioning phase.

o Facility Security and Staffing

It is estimated that 4 security staff will be required to remain on site for a period of three to six months during the implementation of the DMP.




o Internal Resource Requirements

A number of staff members would be required to remain on site for a period of 3-6 months to successfully implement the DMP.

These are estimated as follows:

Management 2

Security Staff 4

Laboratory 3

Administration 2

Other staff 2

The cost of continuing to employ these staff members is expected to be in the region of €460,000.

o Total Cost

The total cost associated with executing a DMP at the Pfizer MAbs SSF site is estimated to be in the region of €1.75 million.

In addition, to maintain an on-going security, safety and environmental monitoring presence at the site would cost approximately €46,000 per annum.

Although the EPA typically has a requirement that post-operational monitoring of groundwater is maintained for up to three years, the duration may be reduced, or the monitoring might be completely eliminated, if no evidence is found of general degradation in groundwater quality.

The following assumptions were made in estimating the likely costs involved:

• The site would be left in a clean condition, i.e. certified as being free of any biological or chemical hazard. All buildings would be retained. All process materials and products would be removed.

• No liabilities would be incurred due to activities of contractors storing and disposing of materials removed from the Pfizer site, as Pfizer will continue to apply its proposed waste management principles.

• No civil liability would be incurred as a result of third parties claiming environmental damage arising from the operational phase or closure.

• The maximum asset value of the facility would be maintained, but no action would be taken to prepare the site for a trade sale as a going concern or otherwise.

• Normal practice would be applied to minimise ongoing liabilities and to fulfil insurance requirements.

• It is assumed that the planning authority would not take any action to prevent site dereliction, as the existing facilities would be maintained in a condition suitable for future beneficial use. The planning authority will be notified of the plans to decommission and will be consulted in relation to the isolation of facilities and services on site.

• In addition, no factors have been identified that would indicate an unusual liability for the site in comparison with other process industry sites.

o Funding of DMP

Pfizer Biotechnology Ireland confirms that the company has more than adequate resources from operations to fund the DMP, as set out above.




Further details on the financial status of Pfizer Inc can be found in the financial reports and 2007 Annual Report available via the following web link:

http://www.pfizer.com/investors/financial_reports/financial_reports.jsp

• DMP Update and Review o Proposed Frequency of Review

The DMP will be reviewed and updated annually as part of the Annual Environmental Report submission to the EPA.

o Proposed Scope of Review

The updated and reviewed DMP will take account of any site or process changes, technology changes and costing changes.

• DMP Implementation o EPA Notification

Pfizer has no current plans to decommission the site. However, should the site be decommissioned, the EPA will be given 3 months notice and 6 months notice of any partial or full closures, respectively. The form of notice will be in accordance with prevailing guidance and it is expected that there will also be discussions with the EPA as part of the process.

o Local Authority Notification

Should the site be decommissioned Cork County Council will be given 3 months notice and 6 months notice of any partial or full closures, respectively. The form of notice will be in accordance with prevailing guidance and it is expected that there will also be discussions with the Cork County Council as part of the process.

• DMP Validation o Closure Validation Audit

An Environmental Exit Audit of the site will be carried out following the announcement of closure and prior to actual decommissioning and closure operations take place. The audit will produce an accurate inventory of all plant, equipment and wastes on the site. This inventory will be used as a benchmark against which successful decommissioning will be assessed.

All IPPC licence monitoring with respect to surface water, effluent, groundwater, soil, waste management, air and noise will remain in effect over the course of the decommissioning phase.

o Closure Validation Audit Report

It is a requirement of the IPPC licence (section 10.4) that a final validation report, including a certificate of completion for the DMP, for all or part of the site as necessary, be submitted to the Agency within three months of execution of the plan. In addition, it is requirement of the IPPC licence that Pfizer carry out such tests, investigations or submit certification, as are requested by the Agency, to confirm that there is no continuing risk to the environment.

o Closure Validation Certificate

Section 10.4 of the IPPC licence stipulates that the final validation report will include a certificate of completion for the DMP.




• References Environmental Protection Agency 2006 Guidance on Environmental Liability Risk Assessment, Residuals Management Plans and Financial Provision EPA Wexford

FIGURES

Figure 9 Site Plan (not to scale)

Appendix A Screening and Operational Risk Assessment

A1 SCREENING AND OPERATIONAL RISK ASSESSMENT A1.1 Introduction

A risk assessment decision matrix has been developed, to classify the Pfizer MAbs SSF site into one of the three Risk Categories as outlined in the EPA Guidance.

The three aspects of the facility which determine the overall risk category of the facility are as follows:

• Complexity – the extent and magnitude of potential hazards present due to the operation of the facility (e.g. a function of the nature of the activity, the volumes of hazardous materials stored on site etc.)

• Environmental Sensitivity – the sensitivity of the receiving environment in the vicinity of the facility, with more sensitive locations given a higher score.

• Compliance Record – the compliance history of the facility and whether soil and/or groundwater contamination is present below the site.

A1.2 Complexity

The activity ‘use of a chemical or biological process for the production of basic pharmaceutical products (Class 5.16 of the First Schedule the Protection of the Environment Act ); where annual production <2000 tonnes’ is assigned a complexity of G3, using the Environmental Agency (England and Wales) Environmental Protection Operator and Pollution Risk Appraisal methodology.

The Pfizer MAbs SSF will engage in activity class 5.16 and the annual production will be less than 2000 tonnes. For the purposes of the risk assessment, the complexity value G3 = 3.

A1.3 Environmental Sensitivity

Environmental sensitivity is considered with respect to six potential receptors:

• Human beings

• Groundwater

• Surface water

• Air quality

• Protected ecological sites

• Sensitive agricultural receptors.

A1.3.1 Human Beings The nearest dwelling to the site is 385 metres from the western boundary. This is assigned an environmental attribute score of 1 (EPA 2006 p13).

A1.3.2 Groundwater Protection The site is underlain by a locally important aquifer, with a high vulnerability. This is assigned an environmental attribute score of 1+2 = 3 (EPA 2006 p13).

A1.3.3 Sensitivity of Receiving Waters The stormwater and treated process waste water will discharge to Cork Harbour, which is not designated under the Urban Waste Water Treatment Regulations (2001), nor are the discharge zones potentially eutrophic coastal and estuarine waters. This is assigned an environmental attribute score of 0 (EPA 2006 p13).

A1.3.4 Air Quality and Topography The terrain in the vicinity of the site is ‘simple terrain’, which is assigned an environmental attribute score of 0 (EPA 2006 p13).

A1.3.5 Protected Ecological Sites and Species The site borders the Monkstown Creek proposed NHA, and is therefore assigned an environmental attribute score of 2 (EPA 2006 p13).

A1.3.6 Sensitive Agricultural Receptors Dairy farming is carried out across the road from the site, within 50 metres of the activity footprint. An environmental attribute score of 2 is therefore assigned.

Environmental Sensitivity Sub Matrix

Environmental Attribute

Environmental Tribute Score

Human Occupation

250m – 1000m from site boundary 1

Groundwater Protection

Aquifer - locally important

Vulnerability rating - high

1

2

Sensitivity of Receiving Waters

coastal and estuarine waters - not designated, not potentially eutrophic

0

Air Quality & Topography

Simple terrain 0

Protected Ecological Sites

Directly bordering a protected site 2

Sensitive Agricultural Receptors

Fruit, vegetable or dairy farming < 50m from site boundary

2

A1.3.7 Total Environmental Attribute Score A total environmental attribute score of 8 is assigned by summing the individual environmental attribute scores. This is classified as ‘moderate’, and is assigned an Environmental Sensitivity Classification of 2.

A1.4 Compliance Record

The Pfizer MAbs SSF will be a newly licensed facility, and will have a compliance record score of 1.

A1.5 Outcome and Risk Category

The product of the complexity score (3), the environmental sensitivity score (2) and the compliance record (1) is 6. This is considered Risk Category 2 (EPA 2006 p10).

As a Risk Category 2 site with no long term issues, a DMP is required, but a Restoration and Aftercare Management Plan is not necessary (EPA 2006 p19).

ATTACHMENT VIII – AER/PRTR 2009

| PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : P0864 2009-01.xls | Return Year : 2009 |

AER Returns Worksheet

Version 1.1.10 REFERENCE YEAR 2009

1. FACILITY IDENTIFICATION

Parent Company Name Pfizer Biotechnology Ireland Facility Name Pfizer Biotechnology Ireland

PRTR Identification Number P0864 Licence Number P0864-01

Waste or IPPC Classes of Activity

No. class_name

5.16

The use of a chemical or biological process for the production of basic pharmaceutical products.

Address 1 Shanbally Address 2 Ringaskiddy Address 3 County Cork Address 4

Country Ireland Coordinates of Location

River Basin District NACE Code 2110

Main Economic ActivityManufacture of basic pharmaceutical products

AER Returns Contact Name Gary Crowley AER Returns Contact Email Address [email protected]

AER Returns Contact Position EHS Lead AER Returns Contact Telephone Number 0215007990

AER Returns Contact Mobile Phone Number 0863916029 AER Returns Contact Fax Number 0215008032

Production Volume 0.0 Production Volume Units

Number of Installations 1 Number of Operating Hours in Year 0

Number of Employees 140 User Feedback/Comments

Web Address

2. PRTR CLASS ACTIVITIES Activity Number Activity Name

4(e)

Installations using a chemical or biological process for the production on an industrial scale of basic pharmaceutical products

3. SOLVENTS REGULATIONS (S.I. No. 543 of 2002)

Is it applicable? No Have you been granted an exemption ? No

If applicable which activity class applies (as per Schedule 2 of the regulations) ? n/a

Is the reduction scheme compliance route being used ? n/a

4.3 RELEASES TO WASTEWATER OR SEWER | PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : 2010 EHS Metrics.xls | Return Year : 2009 |

SECTION A : PRTR POLLUTANTS OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR

SEWER

POLLUTANT METHOD QUANTITY

Method Used SE1

No. Annex II Name M/C/E Method Code

Designation or Description

Emission Point 1

T (Total) KG/Year

A (Accidental) KG/Year

F (Fugitive) KG/Year

13 Total phosphorus C OTH

APHA Methodology 295.0 295.0 0.0 0.0

08

Nitrogen oxides (NOx/NO2) C OTH

APHA Methodology 229.0 229.0 0.0 0.0

* Select a row by double-clicking on the Pollutant Name (Column B) then click the delete button

SECTION B : REMAINING POLLUTANT EMISSIONS (as required in your Licence)

OFFSITE TRANSFER OF POLLUTANTS DESTINED FOR WASTE-WATER TREATMENT OR SEWER

POLLUTANT METHOD QUANTITY

Method Used SE1

Pollutant No. Name M/C/E Method Code

Designation or Description

Emission Point 1

T (Total) KG/Year

A (Accidental) KG/Year

F (Fugitive) KG/Year

303 BOD C OTH APHA Methodology 4868.0 4868.0 0.0 0.0

306 COD C OTH APHA Methodology 9714.0 9714.0 0.0 0.0

5. ONSITE TREATMENT & OFFSITE TRANSFERS OF WASTE

| PRTR# : P0864 | Facility Name : Pfizer Biotechnology Ireland | Filename : P0864 2009-01.xls | Return Year : 2009 |

06/04/2010 09:57

5 24 5 Quantity (Tonnes per

Year) Method Used Haz Waste : Name and

Licence/Permit No of Next Destination Facility Non Haz Waste: Name and Licence/Permit No of Recover/Disposer

Haz Waste : Address of Next Destination

Facility Non Haz Waste:

Address of Recover/Disposer

Name and License / Permit No. and Address

of Final Recoverer / Disposer

(HAZARDOUS WASTE ONLY)

Actual Address of

Final Destination

i.e. Final Recovery /

Disposal Site (HAZARDOU

S WASTE ONLY)

Transfer Destination

European Waste Code

Hazardous Quantity

T/Year

Description of Waste

Waste Treatment Operation

M/C/E

Method Used

Location of

Treatment

Name and Licence / Permit No. of Recoverer

/ Disposer / Broker

Address of Recoverer / Disposer / Broker

Name and Address of Final Destination i.e.

Final Recovery / Disposal Site

(HAZARDOUS WASTE ONLY)

Licence / Permit No. of

Final Destination

i.e. Final Recovery /

Disposal Site (HAZARDOU

S WASTE ONLY)

Within the Country

18 01 03 Yes 0.01 Medical/ Sharps/ Bio Hazardous Waste

D9 M Weighed Offsite in Ireland

SRCL,W0054-02 520 Beech Rd.,Western Ind. Est.,Dublin 12,.,Ireland

SRCL,W0054-02,520 Beech Rd.,Western Ind. Est.,Dublin 12,.,Ireland

.,.,.,.,Ireland

To Other Countries

15 01 10 Yes 2.286 Empty Containers

D10 M Weighed Abroad Veolia Environmental Services Technical Solutions, W0050-02

Corrin, Fermoy, Co.Cork, Ireland

Sava,A 51 G00 508 A51 V00605,Osterwete 1,Brunsbuttle,D-25541,.,Germany

Osterwete 1,Brunsbuttle,D-25541,.,Germany

To Other Countries

07 05 13 Yes 7.354 Chemically Contaminated Process Waste

D10 M Weighed Abroad Veolia Environmental Services Technical Solutions,W0050-02

Corrin,Fermoy, Co.Cork,Ireland



To Other Countries

15 02 02 Yes 1.153 Chemically Contaminated Process Waste


Corrin,Fermoy, Co.Cork,.Ireland



To Other Countries

07 05 04 Yes 0.275 Antifoam, Oils D10 M Weighed Abroad Veolia Environmental Services Technical Solutions,W0050-02

Corrin,Fermoy, Co.Cork, Ireland



Within the Country

07 05 04 Yes 1.106 Solvents, Oils R13 M Weighed Abroad Veolia Environmental Services Technical Solutions,W0050-02




To Other Countries

06 02 05 Yes 0.088 Corrosive Solids Sodium Hydroxide





To Other Countries

16 05 08 Yes 0.021 Waste/Spent Sanitization Agents





To Other Countries

20 01 14 Yes 1.67 Corrosive Waste – Acidic





Within the Country

16 02 13 Yes 0.2 Waste Electrical Electronic Equipment

R4 M Weighed Offsite in Ireland

KMK ,W0113-03 Cappincur Ind Est,Daingean Rd.,Tullamore,Co. Offaly,Ireland

Within the Country

20 01 01 No 5.91 Paper & Cardboard


Veolia Environmental Services,W0173-01

Forgehill, Cork, Ireland

Within the Country

20 03 01 No 131.3 General Waste




Within the Country

20 01 38 No 20.58 Timber R13 M Weighed Offsite in Ireland



Within the Country

17 04 05 No 14.38 Metal R4 M Weighed Onsite in Ireland

Cork Metal,WCP LK-08-589-01

Dublin Hill, Cork, Ireland

Within the Country

20 01 02 No 3.83 Glass R13 M Weighed Offsite in Ireland

Rehab Recycling,WMC 146/03

Monahan Rd., Cork, Ireland

Within the Country

20 01 39 No 2.96 Plastic Packaging and containers




Within the Country

16 10 02 No 26233.0

Process waste water


Pfizer Ireland Pharmaceuticals,P0013-04

Ballintaggart, Ringaskiddy, Co Cork, Ireland

Within the Country

16 02 14 No 0.276 Waste Electrical Electronic Equipment



Within the Country

16 02 16 No 0.02 Waste Electrical Electronic Equipment



Within the Country

08 03 18 No 0.294 Inks & Toners R13 M Weighed Offsite in Ireland

Source Imaging,WP 124/06

Unit 2,Banagher Enterprise Centre,Banagher Enterprise Centre,Co Offaly,Ireland

Documents

Pfizer Biotechnology Ireland - Environmental Protection · PDF fileThe Pfizer Biotechnology Ireland facility at Shanbally ... Separate dispensing areas are provided for handling buffer