QA/QC Microbiology In-Depth Focus 2024

This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.

QA/QC Microbiology IDF

  • Cleanroom microbiology: single temperature incubation for EM
    Single temperature incubation has been discussed for a long time in the pharmaceutical industry but only a few sites have implemented this system. Here, Guillaume Pinon, Head of the Microbiology Lab at Servier, discusses the use of single temperature incubation in an aseptic production facility, outlining the regulatory considerations, strategic approach, challenges and prospects.
  • Endotoxin standards: reflection and recommendation
    Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
  • Improving aseptic connections throughout the manufacturing process
    As companies are adapting to EU GMP guidelines for Annex 1 – Manufacture of Sterile Medicinal products, there have been numerous discussions involving the terms sterile and aseptic, as if they were synonymous. Vanessa Vasadi Figueroa, Chief Microbiologist at VVF Science® and Executive Director of Microbiology & Sterility Assurance at Quality Executive Partners, Inc, explains that this is not correct, and gives a microbiologist’s perspective on why the distinction between these two terms is important to the larger conversation about sterility assurance.

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