Pharmaceutical Case StudyFeasibility Study to Support Integrating the Use of the SteraMist™ Environment System

Dr. Marco Macazzola

For International Use Only

Overview

20

15

1969: Farmitalia built Nerviano plant for animal health products

1975: Farmitalia transferred the production all antracyclines class of product

1980: Farmitalia acquired Carlo Erbaforming Farmitalia carlo Erba (FICE)

1982: FICE moved the production of all injectables products and all R&D activities to Nerviano

1994: Kabi Pharmacia acquired FICE and forming Pharmacia

1996: Pharmacia merged with Upjohn forming Pharmacia & Upjohn

2000: Pharmacia & Upjohn merged with Monsanto to create Pharmacia

2003: Pfizer acquired Pharmacia. Pfizer Italy acquires Nerviano

2004: Pfizer Italia sold the R&D center to NMS

2008: Actavis acquired Nerviano

2012: Watson acquired Actavis

2013: New Actavis was born

2015: Actavis acquired Allergan For International Use Only

Global Footprint- Operations: in + 60 countries,

Actavis plc markets

- 1000 generic, branded generic, established brands and OTCpharmaceutical products and +35 specialty branded products focused principally in the Women's Health, Urology, Gastroenterology and Dermatology therapeutic categories

- Actavis Global Supply Chain: +40 manufacturing and distribution facilities around the world

For International Use Only

•Sterile Cytotoxic parenterals, including freeze dried ones•Sterile non Cytotoxic parenterals, including freeze dried ones•Injectable solutions•Prefilled Syringes

Cytotoxic solution and FD

Non cytotoxic solution and FD

Packaging

Pre-filled syringe

Product Portfolio

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Environment sanitization consolidated system

«On ground»

Efficacy test

Systems/Providers Preliminary study

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First telephone contact

Communication of volume and layout

Preliminary study Service providing

Wednesday

02Thursday

03Friday

04Saturday

05 +Sunday

06

Process

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Rooms’ Volume and Layout

Positioning of the diffusors (3 Units)

Positioning of the indicators

FEASIBILITY STUDY

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Requested SAL = 106

Interested area: two distinct departments

Interested volume = 420 m3 + 780 m3

Time available = 2 days

Sterilization Details

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• Concentration / volume = 28 ml/m3;

• Sanitizing soluzion = Volume * (Concentration / volume)

• Fogging = calculated by Sanitizing solution / Flow per minute

• Contact time = 3 hours minimum (overnight);

• Aeration time = it depends on the HVAC (about 60 min)

Results: Cycling Time

1

2

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Results: Evaluation CriteriaThe final result of the activity has been evaluated following these criteria:

Parameter ObjectiveVerification

methodDiffusion of the H2O2

SolutionAgent’s diffusion is homogeneous allover the area

Chemical Indicators

Decontaminationcycle’s efficiency

SAL = 106 in every chosen samplingspot.

Biological Indicators

Generated fog’scondensation

Avoid an excessive condensation on surfaces (do not overcome the saturation point of the fog), preventingany influence on the sensitive electronic devices.

Visual check

Cycling timeConsidering all the other parameters, sterilization is reached in the shortestperiod of time possible.

Device’s timer

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RESULTS: Homogenous DiffusionIn these pictures you can see the complete turning of the chemical indicators:

Chemical Indicator example before and after the turning:

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Results: Decontamination cycle’s efficiency

The incubation of the bioindicators used were delegatedto the Actavis’s laboratory to guarantee the maximumlevel of transparency. The result was a SAL = 106 for everychosen sampling spot, with the only exception of 1 BI.Since other bioindicators were placed close to the criticalone (compliant results) and considered the trialexecution method (short time), it was considered as notaffecting the whole result.

For International Use Only

The next morning it wasn’t found a significative amount ofcondense on the interested surfaces.

The sensitive electronic devices in the rooms were not affectedby the process, even if some machine casings were open.

Some residues of hypochlorite on the aeration grid did actuallyreact with the generated peroxyde, polimerizing. Such residueshas been easily swiped away through manual cleaning using aspecific cleanser on the interested grid.

Condensation of the generated fog

For International Use Only

Pharmaceutical Case StudyFeasibility Study to Support Integrating the Use of the SteraMist™ Environment System

Dr. Marco Macazzola

For International Use Only