Pharmaceutical GMP Microbiology & Sterility – USP <71>
Sterility testing is an important part of GMP microbiology, and is used to ensure that pharmaceutical and biopharmaceutical therapeutics are sterile and safe for human use.
Testing performed in the microbiology labs at Pacific BioLabs consists of three main categories:
Bioburden testing is performed on nonsterile products to determine the baseline microbiological level of products. Bioburden is performed as part of a sterilization validation, and may be done on a regular basis to measure whether the microbiological load on a product has changed over time.
Bacteriostasis/Fungistasis testing is performed to determine whether a product inhibits bacterial growth or fungal growth so as to ensure that false negatives do not occur during a sterility test.
Sterility testing determines whether a product is sterile and may often be used in the lot release process to verify that the sterilization process has been effective.
Pacific BioLabs microbiology lab offers sterility testing services in an ISO Class 7 Sterility Suite inside ISO 5 laminar flood hoods.
Available GMP Microbiology Sterility Testing Services
- Bioburden Validation and Testing
- Bacteriostasis / Fungistasis Testing
- Sterility Testing
- Direct Transfer
- Closed-System Membrane Filtration
- Media Fill and Growth Promotion
Read More About Sterility Testing
- PBL’s Learning Center – Lot Release Sterility Testing
- PBL’s Learning Center – Pharmaceutical CMC Expectations
- PBL’s Learning Center – CMC Activities for Biologics and Monoclonal Antibodies
PBL’s Sterility Assurance Booklet
Download the free booklet