The weakest link is getting stronger

Research output: Contribution to journalArticle

Abstract

The manufacture of sterile products attracts the greatest regulatory scrutiny of all product types, since manufacturing failures can be fatal and manufacturers are required to utilise the most robust sterilisation method possible to limit the probability of this occurring. However, aseptic preparation, which is the last resort manufacturing method, continues to be employed since for sensitive products this is the only feasible route. Aseptic preparation has always suffered from the potential for undetected, or undetectable, microbial ingress occurring during the manipulation of sterile components. The implementation of isolator systems have provided an advance over standard clean rooms technologies and the weakest link of aseptic preparation is getting stronger.
Original languageEnglish
Pages (from-to)68-72
Number of pages4
JournalEuropean Pharmaceutical Review
Volume14
Issue number6
Publication statusPublished - 2009

Keywords

  • sterile products
  • sterilisation
  • aseptic preparation
  • microbial ingress

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