Key Strategies for Ensuring Reliable and Compliant Sterility Testing in Pharmaceutical Labs

Authors: Sartorius | Last updated: November 2024

Overview

Sterility Testing is designed to confirm that sterile products, such as sterile pharmaceuticals and medical devices, do not contain contaminating viable microorganisms. This essential test determines if a manufactured batch of a sterile product is suitable for release. This resource provides a comprehensive guide to best practices for sterility testing, focusing on membrane filtration methods and strategies to minimize false negatives. Learn how to validate sterility tests, comply with international pharmacopeial standards, and streamline processes using advanced tools like the Sterisart® Universal Pump and Microsart® ATMP kits. The guide addresses challenges in testing pharmaceutical products with antimicrobial properties and offers insights into rapid detection methods, including qPCR, for time-sensitive applications.

Resource Details:

  • Document type: eBook
  • Page count: 38
  • Read time: 25 minutes

 

In this webinar, you will learn:

  1. Best practices for sterility testing to ensure product safety
  2. Simplified sterility testing of therapeutics with antimicrobial properties
  3. What to consider when validating your sterility test containers
  4. Rapid, real-time PCR-based detection of microbial contamination 

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This Resource is Designed for:

  • Researchers in laboratories expressing and purifying proteins which must be pyrogen-free for downstream cell-based assays and animal studies
  • Pharmaceutical Industry Professionals
  • Biologics Manufacturers
  • Cosmetic Industry Professionals
  • Laboratory Technicians and Managers

Applications Supported:

  • Endotoxin/Pyrogen Removal: Endotoxin Removal, Lipopolysaccharide, Pyrogen Removal, Depyrogenation, Endotoxin Clearance
  • Membrane-Based Separation: Membrane Adsorbers, Membrane Chromatography, Sartobind® Lab, Ion Exchange Chromatography
  • Protein Processing: Protein Polishing, Protein Purification, Contaminant Removal