BA Sciences performs three forms of bacterial endotoxin testing according to USP/EP guidelines as part of our pharmaceutical testing. These tests, which use limulus amebocyte lysate (LAL), are: gel clot, kinetic chromogenic, and turbidimetric. In LAL pharmaceutical testing, LAL reacts with minute levels of endotoxin, providing definitive proof that endotoxins are not present in the manufacturing process stream. BA Sciences tests for bacterial endotoxins in samples from all areas of manufacturing: raw materials, pharmaceutical water, in-process intermediates, bulk lot release, and final product release.
Pharmaceutical Microbiology Testing
Biological Indicator Testing
BA Sciences performs definitive biological indicator testing for sterilization validation and lot release, to ensure compliance with USP/EP requirements. Our biological indicator testing services include the full gamut of USP <55> compliant methods, to test for population and resistivity: spore suspension, spore strips, spore ampoules, and metal disc. In addition, BA Sciences offers biological indicator hold time studies to extend the period that strips or ampoules can be stored after sterilization, but prior to testing. As with all of our pharmaceutical testing, we take extreme care to minimize the chance of false positive readings, which can trigger expensive re-testing or can delay release.
Sterility Testing
BA Sciences performs product sterility testing using a class 100 glove box isolator equipped with a vaporized hydrogen peroxide (VHP) sterilization system. The class 100 glove box isolator eliminates the chance for false positives in your sterility tests, and meets USP <71> and EP 2.6.1 compendial standards. We can help you determine if your product is free from the presence of harmful microorganisms that might compromise their safety.