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Product Packaging Brief

GSK - Verona

Introduction

The GSK Verona site is situated on the edge of the historic cityof Verona, approximately 150 km from Milan in northernItaly.The site specialises in the manufacture of sterile Cephalo-sporin finished dose form products for global markets. It has modern facilities for the large-scale manufacture ofvials from aseptic powder fill.

OverviewThe Verona site is a global centre of excellence for the sterilemanufacture of powder fill Cephalosporin vials. The site hascapabilities to aseptic powder fill to standard vials as well asAdd-Vantage (subject to negotiation of the relevant 3rd PartyIP technology) and Monovial devices.It has an excellent quality record in this very challenging environment and considerable experience gained fromworking within GSK, as well as with contract manufacturingfor third party customers. The Verona Site also provides a high quality, secure and cost-competitive option for Cephalosporin finished dose supply.This brochure has been prepared to provide informationon Verona Manufacturing site and its capabilities, both toundertake contract manufacturing work for third partycustomers and give a good knowledge of the site to GSK customers.

Key Capabilities•Sterile powder fill

to vials•Sterile powder fill to

monovials for global markets

•Sterile powder fill to Add-Vantage vialsfor USA*

•Flexible packaging lines for global supply

*(Add-Vantage is a registered trade mark of Abbott USA).

Key Regulatory ApprovalsUSA - FDAEuropeJapanAustraliaRest of World

GSK Verona is a globalsupply site and thusmaintains globalregulatory approvals.

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Product Presentations

Vial 1177 mmll

Verona is currently filling 17 ml vials withfollowing dosages:

• 250 mg• 500 mg• 750 mg• 1 g

17 ml can be packed with 3 ml ampoule

Types of packaging:

• x 1 (with or without ampoule)• x 10 (without ampoule)• x 25 (without ampoule)


Vial 2266 mmll

Verona is currently filling 26 ml vials withfollowing dosages:

• 1 g• 1,5 g

26 ml can be packed with 10 ml ampoule

Types of packaging:

• x 1 (with or without ampoule)• x 10 (without ampoule)• x 25 (without ampoule)

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Vial 6600 // 7777 // 112277 mmll

Types of packaging for big vial size:

• 60 ml x 1 & x 10• 77 ml x 1• 127 ml x 1; x 6; x 10

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Monovial

Vials can be pack with a special deviceused in hospitals called "Monovials"

The device is available for all markets

Monovial is filled in a 22 ml vial x 1

The presentation can also be packed withan infusion bag

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Primary Pack Standard Vial

Vials Components

Vial - Verona uses moulded vial for infusionand injection products. As indicated in USPmethod or European Pharmacopeia glass istype 3 clear hydrolityc resistance.

Stopper - Verona uses no coated, bromobutyl gray rubber stopper for infusionproducts.

Closure - Vials are closed with snap-offclosure. It is tamper evident closurecomposed by aluminium and plastic partsfor vials stoppered with elastometric plugs.

Vial 17 mlISO-DIN 8362

StopperDiameter 20 mm

ClosureAluminium closure Ø

20 mmwith coloured flip-off





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Vials Components

Primary Pack Standard Vial

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Primary Pack Monovial

Cup

Needle

Capsule

Needle Guard

Sealing Ring

Plunger Stopper

Vial

Device ComponentsTransfer set:Capsule Needle Guard: transparent polymerresin Ektar MB DA003Needle: stainless steel, anticoring treatedSealing ring: bromo butyl rubberCup: low density translucide polyethyleneresin Riblene FC20

Plunger stopper:Bromo butyl rubber (ceftazidime)Coated or non coated bromo butyl rubber(cefuroxime)

Vial:Glass clear type 1 as for USP XXII andPh European Brimfull capacity 22ml

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GMS Logistics ManagerGlaxoSmithKline Manufacturing S.p.A.Via Fleming, 2 - 37135 Verona - ItalyTel. +39-045-9219497Fax. +39-045-9218113

Site DirectorGlaxoSmithKline Manufacturing S.p.A.Global Manufacturing & Supply DivisionTel. +39-045-9219629Fax. +39-045-9218108

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Site Business Contacts

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