The stand-alone facility is dedicated to basic USP 51, USP 61, and USP 62 testing.
The stand-alone facility is adjacent to the Container Center of Excellence and is dedicated to basic USP 51, USP 61, and USP 62 testing including raw material through finished products. The facility meets the strict GMP requirements for FDA regulated, GMP testing to take place. All key pieces of equipment include state of the art incubators, ovens, and fume hoods.
The USP 61 product safety testing is required to ensure that a product’s preparation complies with a pre-set specification for microbiological quality. The test is similar to an aerobic plate count assay, as it determines if a product is contaminated with bacteria or fungi. 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 commonly required for developmental formulations through finished products stability.
Common USP tests completed by the laboratory 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
About Whitehouse Laboratories?The Testing Partner to Manufacturing Companies, Whitehouse Labs is an FDA regulated, DEA Licensed, ISO 17025 and ISTA certified contract service provider to the pharmaceutical, medical device, personal and consumer product industries. Whitehouse Laboratories offers analytical services for the testing of materials, finished products, container and package systems that enable our clients to meet and exceed the required quality standards established by the key regulatory agencies.