ebook: Important considerations for every bio-pharmaceutical microbiology QC lab
As microbiology QC scientists you are a crucial part of the manufacturing process and carrying out all tests in a reliable, accurate and timely manner, following quality procedures and regulatory requirements protects patient health and enables products to be released on time.
Safety and compliance are key to all processes and this ebook highlights important considerations for your microbiology QC lab, with particular focus on:
- The importance of continuous air monitoring for cleanrooms according to Annex 1 regulations
- Sterility testing for final release of cell therapy products
- Sampling from a closed system sterility testing unit.
Developing well-designed environmental monitoring programmes requires an understanding of the risks, contamination sources and strategies to reduce those risks. Dr Tim Sandle explores why risk assessments are requisites for building a compliant environmental monitoring regime, to meet the regulations in the revised EU good manufacturing practice (GMP) Annex 1, while delivering an effective programme.
Claudia Scherwing and Jasmin Bunke present the results of a study, Continuous Microbial Air Monitoring in Clean Room Environments, which aimed to establish whether a continuous sampling (and multisampling point assay) provides effective monitoring for the entire production process.
Time-to-result is an important attribute of testing for short shelf-life cellular therapeutics and a study from Luebbers et al. compares the microbial detection capability of a highly sensitive and broad range microbial detection system with the compendial sterility test.
Arjan Langen and Kim van Boxtel evaluate rapid sterility test methods to assess if a rapid, non-compendial sterility test can be performed prospectively, while the final study in this ebook from Puttana et al. evaluates the Sterisart® closed system sterility testing device, with a septum, for the recurrent sterile extraction of samples.
The biggest challenge for quality control in the biopharma industry is in reducing the risk of contamination. This ebook is designed to give you the tools you need to address the challenges that you face every day in the lab, ensuring that patient health is not affected by the release of a contaminated product and that product release is timely.