Pharmaceutical Sterility Testing – USP <71>
Sterility testing of sterile pharmaceuticals is an important part of GMP microbiology, and is used to ensure that pharmaceutical and biopharmaceutical therapeutics are actually sterile and safe for human use. USP <71> prescribes the sterility testing method used for pharmaceuticals and biologics.
Sterility Testing Suitability Testing
Before beginning the sterility test, a method suitability test should take place. This method suitability test is called the Bacteriostasis & Fungistasis test. Bacteriostasis and Fungistasis combines the sample and less than 100 CFU of six different organisms with media. If the microorganisms are able to grow it means that the sample does not inhibit their growth and sterility testing can proceed.
USP <71> sterility testing is performed in two different types of media, one specific for aerobic organisms and one that is capable of sustaining growth for both aerobic and anaerobic organisms. The sample is introduced to media by either direct inoculation or by membrane filtration. The amount of sample required depends on the type of product being tested and the size of the batch produced. Sterility testing requires an incubation period of fourteen days. After the fourteen day incubation, if the media is clear and there are no sign of microbial growth, the samples are considered sterile.
Pacific BioLabs’ microbiology lab offers sterility testing services in an ISO Class 7 Sterility Suite inside ISO 5 laminar flood hoods and biological safety cabinets.
Available GMP Microbiology Sterility Testing Services
- 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