We offer a broad range of cGMP microbiological testing services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards, and client specific protocols. We test raw materials, in process materials, and finished products. A complete list of the tests we provide can be found on our downloadable information sheet.
We validate compendial methods for your product. We offer endotoxin testing by gel-clot, kinetic chromogenic, and turbidimetric methods and can validate these methods for your product with respect to inhibition and enhancement. We validate bioburden testing with recovery studies and perform bacteriostasis/fungistasis testing to validate sterility test methods.
We can generate the data you need to support your regulatory filings. We provide a range of testing services, including environmental monitoring, container closure integrity (micro ingression and dye immersion), disinfectant efficacy, preservative effectiveness, and water quality testing.
10 Vanderbilt Avenue
Irvine, CA 92618
Tel: (949)-951-4425
Fax: (949) 951-4909
6 Vanderbilt Avenue
Irvine, CA 92618
4 Chrysler
Irvine, CA 92618
