A Best Practice Video Guide for Sterility Testing with Sterisart | Sartorius

A Best Practice Video Guide for Sterility Testing with Sterisart

Authors: Dr. Eric Clement Arakel and Marius Iseke | Last updated: May 2024

Overview

In the pharmaceutical industry Sterility Testing is a key compendial final release regulatory requirement and is designed to confirm that sterile products, such as sterile pharmaceuticals and medical devices, do not contain contaminating viable microorganisms, according to EP2.6.1, USP 71, JP 4.06 and ICH Q4B Annex 8. This essential test is part of the strategy to assess if a manufactured batch of a sterile product is suitable for release.

In this video, we guide you through how best to perform your membrane filtration based sterility testing.

  • Document type: Video
  • Page count: 1
  • Watch time: 14:09 minutes

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Key Takeaways:
  • Detailed description of the preliminary set-up
  • Visual guidance through each step of the testing process including pre-wetting, product filtration, rinsing and media fill
  • Useful tips for the incubation, inspection, and readout
  • In-depth guide of the sterility testing workflow in advanced aseptic processing systems such as RABS (Restricted Access Barrier System) and isolators

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