GSK – GlaxoSmithKline

A Comecer Pharma Reference

Advanced Plant for Bulk Sterile Manufacturing

Locatie: Worthing

Categorie: Pharma

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Advanced Plant for Bulk Sterile Manufacturing

Customer

GSK (Worthing, UK)

Customer Challenge

Blender charging and final filling of bulk antibiotic powder in entirely aseptic conditions, using isolation technology, with the highest operational efficiency, and a fully automatic process.

Performance Requirements

  • Three multi chamber lines to handle aluminum containers in the different process phases
  • Maximum use of automation to avoid human intervention
  • Autoclave integrated with isolator line
  • First of a kind filling accuracy in the application as well as mandatory “no powder” in isolator, to prevent explosion-proof classification

Solution Highlights

Comecer designed and built three fully automatic lines plus a component preparation isolator. This project delivers an integrated turnkey solution never done before in any other scenario for the particular bulk sterile manufacturing application:

  • Automatic discharge station under aseptic condition
  • Washing and drying in isolator
  • Autoclave offloading with anthropomorphic robot under Grade A isolator
  • A specially designed filling system, including a stellar valve to reach a ±25g accuracy on 10kg fill
  • CIP and SIP automatic setup on all product contact parts
  • Automatic overwrapping under Grade A condition

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