Chromak Research provides USP <71> Sterility Testing of sterile pharmaceutical products, medical devices and water. Sterility testing is required during the sterilization validation process as well as for routine release testing.
All sterile samples are prepared and inoculated in ISO 5 hoods in ISO 7 clean rooms, to eliminate laboratory contamination. We can test sterile product with Membrane filtration and Direct inoculation methods.
Chromak Research Labs performs growth promotion testing to confirm that each lot of media can support growth of the six microorganisms stated in USP <71> Sterility Tests. Prior to conducting a USP <71> sterility test, our laboratory performs method suitability for each specific product formulation to ensure that an appropriate method is chosen for testing.
