PW/WFI System Partner - Honeyman Group Limited · 3 Contact us for further details of our services and our full range of testing UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488 WHY

1

PW/WFI System

Partner

New & Existing Systems Service Guide

UK & Ireland Operations

WATER

2

Contact us for further details of our services and our full range of testing

www.honeymangroup.com

A TRANSPARENT & FRIENDLY APPROACH

As a valued client of Honeyman Water, you will have regular interaction with your ap-

pointed account manager and dedicated contacts.

Our pro-active and approachable Operations Directors are always available to deal

with any queries or questions that you may have. They are continually seeking to im-

prove the customer experience whilst ensuring compliance and timely delivery of pro-

jects.

Founded in 1991, Honeyman Group Ltd operates from facilities in the UK &

Ireland, offering a range of products and services to the Pharmaceutical,

Biotech, Healthcare and Medical Device industries.

SETTING NEW STANDARDS

Tom Honeyman

CEO & Director of Engineering

[email protected]

Ben McQueeney

Director of Laboratories

[email protected]

Marcus Booth

Director of Training & Consultancy

[email protected]

1

3


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

WHY Honeyman Water?

KEY

Engineering

Division

Laboratories

Division

Consultancy

Division

Training

Division

Validation

Division

Design

Build

Installing

IQ/OQ PQ & Routine

Test

Troubleshooting

Scope/URS

Maintenance

The Honeyman Group consists of 5 Divisions; Engineering, Validation, Laboratories, Con-

sultancy and Training. Each of these divisions provides different services to enable a ‘one

stop’ approach to quality water systems.

1. One vendor and one contact for all your PW/WFI needs!

2. Save £ Millions over the lifetime of your water system with innovative and

patented technology exclusive to Honeyman

3. Create your own bespoke support package—from a small job to com-

plete turnkey projects.

4. Industry specialists-not just water specialists. Engineering and Laborato-

ries backed up by regulatory professionals.

5. New systems, Old systems—Honeyman has you covered!

How different divisions of the Honeyman Group can provide life-

time support of your water system:

2

4



PROJECT SCOPING & URS

“By failing to prepare, you are preparing to fail.” - Benjamin Franklin

The first step in any successful project is being able to clearly define outcomes and

goals. What do you want from your water system? Whilst that may seem a simple ques-

tion, getting to the correct answers isn't always as straight forward as it seems. A badly

specified system can put unnecessary constraints on site operations and can be costly

to rectify once installed.

At Honeyman, we can join you at the beginning of projects; whether a new system or

amending a current system, we can help you plan and ask the right questions to enable

the correctly installed system within your facility.

Following a detailed consultation with the Honeyman team, we can efficiently produce

a precise and clearly defined URS that all project stake holders can buy into.

Utilising our decades of experience in quality water systems, you can be confident of re-

ceiving the very best system for your facility, meeting your requirements and whilst ensur-

ing regulatory compliance.

Best approach—a good URS reduces iteration, surprises, unplanned events and prob-

lems

DQ

IQ/OQ

PQ

URS

• To specification

• On time

• On Budget

3

5


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

Headed up by Dr Alan Bateson, the Honeyman design team has been providing reliable

and carefully planned Cad designs in 2D/3D for over 25 years. In addition to designing

Honeyman’s own range of PW/WFI water systems called HydroGienic®, the team also

carries out design work for a range of clients and third party equipment vendors.

The team have designed hundreds of new and modified systems over the years for a

broad range of clients. Experience gained over these years has led Honeyman to design

extremely innovative systems with a proven track record of delivering some of the most

reliable and trusted systems in the industry.

DESIGN & DOCUMENTATION

4

6



Honeyman proudly partners with Bram-Cor S.p.A based in Italy to provide some of the

finest pre-treatment and generation systems on the market.

Following a careful evaluation of site feed water by Honeyman Laboratories, Honeyman

Engineering will design a suitable Pre-treatment for manufacture.

Raw water can be pre-treated to remove contaminants through steps including UV

lamps, microfiltration, ultrafiltration, multimedia filters, softners.

For an effective microbial control, systems can be specified to be hot water sanitisable.

PRE-TREATMENT & GENERATION

Example of a skid mounted Honeyman pre-treatment system. Sizing and technologies vary considerably

based upon raw water qualities.

5

7


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

PRE-TREATMENT & GENERATION

Having selected the correct pre-treatment system, Honeyman will then design a be-

spoke purified water generation system. Skids can be designed to generate PW at a rate

between 100-20,000 lph.

Purified water is usually obtained through a single or double osmotic stage and for a

higher quality, water is additionally passed through a continuous electro-deionizer.

• Can be designed to deliver PW generation capacity from 100—20,000 lph

• Complies with GMP and regulatory body requirements

• Sanitary in-line instrumentation to monitor product critical parameters such as con-

ductivity, temperature, Ozone in water, TOC and pH.

• Chemical, Heat or Ozone sanitisable

A large capacity skid mounted Honeyman cEDI/RO system

6

8

Contact us for further details of products and services


DISTILLATION & STEAM

Single Effect Distiller

The Honeyman single effect distiller is both a Still

and a Pure Steam Generator. This equipment

produces dry, saturated steam that can be used

for sterilisation. The pure steam when

condensed through a double tube sheet

condenser, meets the requirements of WFI.

Vapour Compression Distiller

The Honeyman Vapour Compressions Distiller

can produce both hot or cold distillate with

huge savings of energy costs and with no need

of cooling water. Vapour compression distillers

operate with electrical heating and/or plant

steam. Capacities range from 20 –20,000 lph.

Multiple Effect Distiller

The Honeyman Multiple Effect Stills are designed

and manufactured according to cGMP to

produce Water for Injection. Each unit contains a

number of boiling columns (or effects) with the

first column producing pure steam, which is

condensed and re-distilled in the following

columns decreasing operational costs.

Pure Steam Generator

With a capacity ranging from 20-5000 kg/h, the

Honeyman Pure Steam Generator produces dry,

saturated steam, suitable for a wide range of

uses within the pharmaceutical production plant.

7

9


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

STORAGE & DISTRIBUTION

Once water has been produced of the desired grade, it needs to be stored and dis-

tributed to the users within the facility whilst maintaining the quality.

Honeyman can design and build any sized vessel to a range of finishes suitable for

storage of bulk compendial grade water.

With regards distribution, Honeyman offers two solutions. Firstly, Honeyman offers a

traditional piped ring main design.

This approach typically involves pumping water from the vessel around the facility

along one or more stainless steel loops.

Whilst this is currently the most popular way of distributing water throughout facilities, it

is not without its limitations.

Facilities are ever changing, the practicalities and high cost of maintaining such a rig-

id system are making an increasing number of sites consider Honeymans alternative

solution—HydroGienic®.

A HydroGienic® purified water system installed at Dechra Manufacturing in the UK

8

10



Making water work for you—

don’t let PW/WFI be a production bottleneck!

Created and manufactured by Honeyman, piloted by GSK and installed in facilities

around the UK, HydroGienic® is making a big splash in the industry!

Complying with GMP and regulatory requirements, with systems inspected by regulatory

bodies from around the world, HydroGienic® is revolutionising sites approach to distribu-

tion of compendial water.

Main advantages of HydroGienic® in comparison to a conventional SS loop;

• 50% reduction in total installation time and 75% reduction in “plant room to user-

point” installation time, vastly reducing disruption to the current production area, and

overall project time and cost.

• HydroGienic® can provide capital savings in the order of 25% on systems typical for

the industry.

• Vastly reduces and simplifies validation effort and cost, as NO hot working is installed

in production areas – minimising facility disruption

• Delivers 100% diversity i.e. all users can draw water at the same time without impact

upon individual user pressures and flowrates

• Easy to install along existing conventional pure water systems eg those requiring new

or additional users without disruption to the existing distribution loop

• Lifetime cost of ownership cost reduction of 90% compared to conventional stainless

steel loop or an ROI of 400% over 20 years against conventional stainless steel

• “Plug and play” addition of user-points with minimal disruption to production and min-

imised validation cost.

• Significantly reduces the risk of rouge for-

mation (PTFE will not rust)

HYDROGIENIC®

9

11


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

PW SYSTEM CASE STUDY

The Client:

An innovative and rapidly expanding company, Dechra Pharmaceuticals

PLC (formerly Dales Pharmaceuticals) provides a wide range of contract manufactur-

ing and packaging services to the global pharmaceutical industry.

Location:

Skipton, North Yorkshire, United Kingdom

Scope:

The Honeyman Group undertook a turnkey project to design, install, validate and

commission a HydroGienic® Purified Water generation, storage and distribution sys-

tem.

Background:

Site expansion plans meant that Dechra Pharmaceuticals required a new Purified Water

system that would generate and supply water to two separate production buildings.

Having initially considered a conventional stainless steel loop system, Dechra Pharma-

ceuticals soon recognised that in order to achieve adequate functionality, two separate

loops would be required. With concerns regarding space constraints, cost efficiency and

the ability to easily modify the system in the future as and when client needs dictat-

ed, Dechra Pharmaceuticals instead opted for a HydroGienic® system.

Vital Statistics:

• PW Generation: RO and CEDi

• PW Throughput: 3m3per hour

• PW Vessel Capacity: 5m3

• Number of Offtakes: 10 in 2 Buildings

• Flowrates at Offtakes: Range From 10 to 50 lts/min

• Total Output Capability: 171 lts/min, at 100% diversity

• Sanitisation: Intermittent Ozonisation

Cost Comparison: Approximately 15% cheaper than conventional system

3000 litres of Purified Water per hour is generated by a bespoke HydroGienic® genera-

tion system which is then stored in a 5000 litre customised vessel before being distributed

to 10 points of use around the facility via the unique HydroGienic® distribution system.

10

http://www.dechra.com/

http://www.dechra.com/

12



The neat and compact design of the HydroGienic® system meant that any concerns re-

garding the availability of space in the plant room and roof voids were overcome from

the outset. Employing small bore PTFE hoses rather than stainless steel pipes not only en-

sures a compact design but allows a quick and easy installation with a significantly re-

duced validation effort subsequently leading to reduced project timescales and cost.

Alleviating the problems encountered with the existing system and overcoming all the

restrictions imposed by a conventional stainless steel loop system, the design of the Hy-

droGienic® distribution system enables Dechra Pharmaceuticals to:

• Use each user point simultaneously without any compromise to flow rates.

• Easily expand or modify the system in the future with minimal disruption to production

and downtime.

• Isolate individual user points for sanitisation and maintenance quickly, effortlessly and

without impact on any other user point.

• Eliminate ‘hot working’ in production areas during the installation and thus avoiding

disruption to the facility.

Mike Annice, Managing Director of Dechra Pharmaceuticals said: “The nature of our

contract manufacturing business is such that we need to be able to alter production

schedules quickly and efficiently in order to meet changing client requirements, funda-

mental to this are facilities that can be easily adapted, with its ease of modification and

flexibility in expansion with minimal compromise to production a HydroGienic® Purified

Water system allows us to do exactly that”

Since the installation, Dechra Pharmaceuticals have continued to expand the system in

line with production requirements.

PW SYSTEM CASE STUDY

11

13

TRAINING & CONSULTATION

Training on water maybe given on many levels. At a user level, hands-on practical

courses are offered for either users or maintenance personnel.

Honeyman offers a professional level training program on “Pharmaceutical Water

Systems: Priciples in Practice” which gives a much broader overview of water system

design, functionality and regulatory expectations.

This interactive program will see delegates apply their newly acquired knowledge

and design their very own water system, which will be fined tuned as the course pro-

gresses until they end-up with a highly efficient and effective PW/WFI water system.

Delegates on this course have the option to become an ‘Accredited Specialist’ in

Pharmaceutical Water Systems. This is accreditation is run in conjunction with Teesside

University.

Visit our website www.honeyman.co.uk/training-courses for our current course pro-

spectus or contact us if you would like a bespoke course delivered on your site.


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

INSTALL & COMMISSION

Following a successful build and Factory

Acceptance Test (FAT), equipment will be

shipped to site.

On arrival, equipment will be unloaded

and safely sited and secured in the plant

room. Our experienced, trained engi-

neers of a variety of disciplines will set to

work assembling the plant and connect

to site services.

After the equipment has been brought

online, qualification and commissioning

activities will begin.

12

http://www.honeyman.co.uk/training-courses/

14



Honeyman Laboratories offers a complete outsourced testing service for Performance

Qualification (PQ) or Routine testing of water systems. Alternatively, bespoke packages

can be made to suit your requirements comprising of:

• Analysis: Complete Chemical, Microbiological and Endotoxin analysis within a regula-

tory body inspected laboratory facility.

• Documentation services: Rationale, Protocols, Reports, OOS.

• Sampling services: Trained resource to take samples within your facility.

• Transport services: Honeyman transport network will collect samples from your facility

ensuring temperature and time critical requirements are met

Quality

• Fully GMP compliant: Consistency, reliability and traceability.

• Regulatory body inspected.

• Qualified Person (QP) for contract consultation and batch release

• Independent quality department which performs regular self-inspection

• We welcome clients to visit or audit our first class Laboratory facilities and systems.

PQ & LAB TESTING

Kirsty, Senior Microbiology Analyst, carrying out membrane filtrations as part of a client purified water PQ

13

15


UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488

MAINTENANCE & BREAKDOWN

Equipment maintenance matched to the exact requirements of each individual system

or piece of equipment.

Our cost effective, flexible service and maintenance plans can be tailored to include a

range of routine and breakdown services as required.

As the industry’s leading, independent specialists in high purity water systems and sterili-

sation processes we can provide comprehensive service and maintenance cover for a

range of quality critical utility processes and equipment including:

• PW/WFI Purification, Storage and Distribution (including Elga/Veolia, Stilmas, Bram-

Cor, Purite, BCD, BWT, Bosch, Telstar)

• Pure/Clean Steam Generators (including Telstar, Stilmas, BWT, Spirax Sarco, Steris)

• Autoclaves (including Getinge, Fedegari, Denley, Boxer, Tuttnauer, BMT, BMM Wes-

ton)

• Ovens

• Disinfectors

• Washers

There are a number of advantages to using a third party provider such as Honeyman

Group Ltd:

1. Lower maintenance prices

2. Support for multiple manufacturers – all in a single contract

3. Support for older systems no longer handled by the OEM

4. Support backed up by our team of industry leading team of consultants and engi-

neers.

Our strength is the range of specialist in-house expertise we bring to each project. We

can provide the combination of design, engineering, technical, microbiological, regula-

tory and project management expertise which is essential to meet quality –as well as

time and cost – criteria.

14

16

Honeyman Group Ltd, Harmire Enterprise Park, Barnard Castle, Co. Durham, DL12 8BN, United Kingdom

Tel: +44 (0) 1833 690101 Website: www.honeymangroup.com Email: [email protected]

Honeyman Ireland, 26 Laurence Street, Drogheda, County Louth, A92P5VW, Republic of Ireland

Tel: +353 (0) 1 556 3488 Website: www.honeymangroup.com Email: [email protected]

WATER

Part of Honeyman Group Limited

SETTING NEW STANDARDS

Documents

PW/WFI System Partner - Honeyman Group Limited · 3 Contact us for further details of our services and our full range of testing UK: +44 (0) 1833 690101 IE: +353 (0)1 556 3488 WHY