QA/QC & Environmental Monitoring In-Depth Focus 2021

Posted: 26 August 2021 | | 1 comment

In this in-depth focus, learn how to overcome interfering factors when using LAL for endotoxin testing and discover how the implementation of a new scrubs system benefited an aseptic production facility.

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    • Bacterial Endotoxin Test using LAL methodology: overcoming interfering factors
      The Bacterial Endotoxin Test, using LAL methodology, is a key in-process and final product release test for sterile pharmaceuticals and medical devices. One of the challenges with LAL methodology is overcoming interfering substances as demonstrated by inhibition or enhancement of an endotoxin challenge. Here, Bio Products Laboratory’s Dr Tim Sandle discusses the interfering substances issue and provides some guidance to overcome it.
    • Scrubbing up the environment
      Here, colleagues from University Hospitals Bristol and Weston NHS Foundation Trust (UHBW) share the beneficial impact of reduced cleanroom environmental contamination following an upgrade to their facilities and procedures.

    One response to “QA/QC & Environmental Monitoring In-Depth Focus 2021”

    1. Enjoyable read, lots of good microbiological advice. The updates about sterile area environmental monitoring and LAL testing were very useful.

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