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Following the test requirements set forth in USP <71> Sterility Tests or ISO 11737, Pace Analytical Life Sciences’ Oakdale Minnesota assures you of well-designed sterility testing procedures, adherence to test methodology, a fully trained cGMP staff, a qualified lab environment along with a well supported quality assurance program. Sterility assurance testing is a very demanding procedure requiring properly trained and qualified personnel due to the range of possible sample types from injectable solutions to ointments and creams to solids to aerosol products and even a wide range of medical devices and their components. Our personnel within the Oakdale, MN laboratory have many years' experience in both the membrane filtration method, the method of choice for most pharmaceutical products, and in direct inoculation of the culture medium, used with medical devices. Additional test methods for sterility include product immersion and product flushing. Sterile product testing, including QC testing for injectable drugs, is performed daily within our laboratory.

Sterility testing, at Pace Analytical Life Sciences, LLC, is carried out in aseptic conditions in a class 10,000 clean room. Our lab personnel take all the necessary precautions from sample receipt thru the sterility testing process to avoid any contamination that could influence the outcome of a test. Quality sterility testing data is used to support later sterilization validation testing such as bacteriostasis/fungistasis testing.

Pace Analytical Life Sciences brings years of experience performing all types of analytical testing on many drug substances, drug products and medical devices. We bring the highest level of quality and attention to detail to our clients to assure that their sterility testing program will be successfully executed.

We are FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025 accredited.

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