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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)
Product Presentations
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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Product Presentations
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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Product Presentations
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
Vial 26 mlISO-DIN 8362
StopperDiameter 20 mm
ClosureAluminium closure Ø
20 mmwith coloured flip-off
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Vial 60 mlISO-DIN 8362
StopperDiameter 20 mm
ClosureAluminium closure Ø
20 mmwith coloured flip-off
Vial 77 mlISO-DIN 8536
StopperDiameter 32 mm
ClosureAluminium closure Ø
32 mmwith coloured flip-off
Vial 127 mlISO-DIN 8536
StopperDiameter 28 mm
ClosureAluminium closure Ø
28 mmwith coloured flip-off
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