Key Strategies for Compliant Sterility Testing in Pharmaceutical Labs

Best Practices to Ensure Reliable and Efficient Membrane Filtration

Sterility testing is a critical process to ensure that pharmaceuticals and medical devices remain free from viable contaminating microorganisms before release. This comprehensive guide addresses the challenges and provides step-by-step solutions for performing membrane filtration-based sterility tests effectively.

Key stages covered include:

Preliminary Set-up: Proper preparation to mitigate contamination risks.
Membrane Pre-Wetting: Ensuring smooth filtration by preparing membranes correctly.
Product Filtration & Rinsing: Avoiding residue build-up while maintaining test integrity.
Media Fill & Incubation: Promoting microorganism growth for reliable detection.
Inspection & Readout: Ensuring accurate analysis and recording of results.

The guide emphasizes method validation and revalidation to maintain consistency and compliance. Additionally, it features an application note exploring Sartorius Sterisart® closed-system sterility testing devices, which demonstrate performance and reliability for preparing therapeutics with antimicrobial properties. The guide also features an application note on aseptic sampling and supplementation from a closed sterility testing canister, without compromising its integrity after multiple sampling events.

By adhering to these best practices, labs can address contamination risks, improve efficiency, and ensure sterility test accuracy—critical for product safety and regulatory approval. Download the eBook to learn more.

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