Pace Analytical Life Sciences (PLS) medical device sterility testing methods meet the requirements established in USP <71> and ISO 11737-2.
PLS personnel have demonstrated experience with a wide range of dosage forms, including terminally sterilized parenterals, compounded products, medical devices and combination products. PLS performs traditional membrane filtration, closed filtration using the SteriTest system and direct inoculation. Experienced microbiologists work directly with the client to ensure recovery method suitability is appropriate for each product configuration. Medical device sterility testing at PLS is carried out in ISO Class 3 hoods in an ISO Class 7 clean room. Stringent procedures are in place to prevent false positive results. Historical trend reports that detail environmental monitoring data and false positive rates are available upon request.