Bacterial Endotoxin Testing
Boston Analytical performs three forms of bacterial endotoxin testing according to USP/EP guidelines. These tests, which use limulus amebocyte lysate (LAL), are: gel clot, kinetic chromogenic, and turbidimetric. In LAL testing in pharmaceuticals, LAL reacts with minute levels of endotoxin, providing definitive proof that endotoxins are not present in the manufacturing process stream. Boston Analytical 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. We can help eliminate endotoxins from your manufacturing process to ensure the safety of your product.
Biological Indicator Testing
Boston Analytical 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, Boston Analytical offers biological indicator hold time studies to extend the period that strips or ampoules can be stored after sterilization, but prior to testing. We take extreme care to minimize the chance of false positive readings, which can trigger expensive re-testing or can delay release.
Boston Analytical performs product sterility testing using a class 100 glove box isolator equipped with a vaporized hydrogen peroxide (VHP) sterilization system or an ISO 5 cleanroom. 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.
In Vitro Microbial Kill Rate Study
Boston Analytical performs in vitro microbial kill rate studies to evaluate the antimicrobial effectiveness or to demonstrate bioequivalence of two pharmaceutical compounds. We test against the bacteria and fungi you specify, in addition to those listed in USP <51>. The recovery method and its ability to neutralize the antimicrobial compounds present are demonstrated during the validation of in vitro microbial kill rate studies. Boston Analytical will help you determine the antimicrobial effectiveness of your product to help move it forward in the approval process.
Pharmaceutical Testing Services
- USP <85>, “Bacterial Endotoxin Test”
- USP <55>, “Biological Indicators – Resistance Performance Tests”
- USP <71> and EP 2.6.1 Sterility Tests
- USP <51>, “Antimicrobial Effectiveness Testing”
- Antimicrobial Effectiveness and Preservative Efficacy Testing
- Bioburden Hold Time and Microbial Kill Rate Studies
- Pyrogen Routine and Validation Testing