Microbiological Laboratory

Using an outside, independent testing laboratory to prove compliance to regulatory requirements can free up your resources to concentrate on product development. Our experts bring many years of experience in the pharmaceutical, cosmetic and consumer industries, and we have handled a diverse and vast list of products and specifications. We also provide guidance to ensure your product receives the appropriate testing.

Our stand-alone facility is adjacent to the Container Center of Excellence and is dedicated to USP <51>, USP <61> and USP <62> testing that covers raw materials through finished products. The facility meets strict requirements to ensure we conduct FDA regulated, GMP testing. Our key pieces of equipment include world-class incubators, ovens and fume hoods.

USP <61> product safety testing is required to ensure that a product’s preparation complies with a preset specification for microbiological quality. In a similar function, USP <62> testing evaluates for specific pathogens including S. aureus, P. aeruginosa, E. coli, Salmonella species, Clostridium species, fungal organisms and a qualitative MPN for bile-tolerant gram negative bacteria. USP <51> is a preservative effectiveness test that is required for developmental formulations through finished products stability.

Our experts conduct tests that include:

• USP <51> Antimicrobial Effectiveness Testing
• USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
• USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
• USP <87> Biological Reactivity Tests, In Vitro
• USP <1231> Water for Pharmaceutical Purposes
• Standard Methods – For the Examination of Water and Wastewater

We are an FDA-regulated, DEA-licensed, ISO 17025 and ISTA-certified contract service provider to the pharmaceutical, medical device, personal and consumer product industries. We offer analytical services for the testing of materials, finished products, container and package systems that enable you to meet the required quality standards established by key regulatory agencies.