Advanced Plant for Bulk Sterile Manufacturing

A Comecer Isolation Technology Reference

Advanced Plant for Bulk Sterile Manufacturing

地点: Worthing

类别: Isolation Technology

警告!本页内容仅提供以下语言版本: 英语

TITLE: 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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