Facilities

Infinity’s Castle Rock, Colorado, facility acts as our headquarters, connecting our state-of-the-art testing facilities nationwide to deliver quality, on-time contract testing services.

Our state-of-the-art Petaluma site is ISO 9001:2015 certified and is FDA-registered. Laboratory services encompass offsite clean room validation and monitoring, water testing, bioburden, LAL sterility testing for medical devices, and environmental monitoring of plates and incubators.

Our San Jose facility provides robust package and environmental testing services for medical devices, pharmaceutical drug products, and combination drug products. Services include package integrity, distribution testing, conditioning, accelerated aging, shelf life, cross-leak testing, peel strength, and cosmetics package testing.

Infinity provides full-service medical device EO sterilization at our FDA-registered San Jose site. Services include EO sterilization, validation, adoption, batch release, cycle development, and biological indicator qualification.

Infinity’s FDA registered San Diego site provides laboratory services for medical devices and pharmaceutical drug products. Services include EO residuals, bioburden, LAL sterility tests USP <61,62>, biological indicators, ID testing, EMPQ cleanroom validations, mycoplasma (PCR) testing, water testing, appearance, pH, media fills conductivity, and media development.

Our Crown Point facility is FDA-registered and DEA-licensed, providing microbiology testing to the medical device and pharmaceutical industries. The full list of services offered here consists of USP <61,62, 85, 51, 71>, water testing, LAL sterility testing, CCIT, bioburden, media fills, feasibility studies, disinfectant efficacy, BI tests, CDA, IDS, and gram and spore strains.

Our St. Louis extractables & leachables site provides comprehensive E&L services encompassing medical devices, biologics and biopharmaceuticals, material characterization and compatibility, impurity/degradant characterization identifications, method development and validation, chromatography, and spectroscopy.

Our North Brunswick site provides robust laboratory services for pharmaceutical, medical device and consumer products companies, including chemistry, microbiology testing, and stability testing.

Additionally, our North Brunswick site provides one-stop laboratory instrument, calibration, metrology, and asset management services.