Expert Microbiology for Medical Devices
Meet the latest regulatory requirements and safeguard patient safety with medical device microbiology testing performed by our team. We provide guidance on determining the most appropriate testing procedures for your product and manufacturing procedures. Our bioburden, BI, sterility, and endotoxin testing services are powered by our unique and specialized knowledge to help fulfill your requirements and support quality assurance.
Microbiology Testing Services
Bioburden testing is done to determine the population of viable microorganisms in or on a pharmaceutical product, medical device, or component prior to sterilization. We have methods in place to perform medical device bioburden testing in accordance with ISO 11737-1. If needed, our teams can also test according to your specified methodology or according to USP <61> or USP <62>. Our experienced microbiologists work directly with you to determine the appropriate sample preparation/extraction procedures to ensure the bioburden test results meet your requirements.
Our team provides medical device biological indicator testing, or BI testing, for the pharmaceutical, biopharmaceutical and medical device industries. The test, according to USP <55>, is designed to support:
- Sterilization indicators
- Sterilization validation
- Sterilization monitoring
- Steam sterilization effectiveness
- Ethylene oxide (EO) sterilization effectiveness
- Sterility cycle lethality
- Lot release for compliance with testing requirements
The test consists of spore strips impregnated with several organisms’ spores and then subjected to your indicated sterilization process. The biological indicators’ viability is then an indication of the sterilization process effectiveness. Since spores are especially difficult to sterilize, their absence assures the process is validated and the testing provides accurate results. The number of strips used during the testing should be based on the usable chamber volume of the sterilizer or the product load size.
Our medical device sterility test methods meet the requirements established in USP <71> and ISO 11737-2. Our experts have demonstrated experience with a wide range of dosage forms, including terminally sterilized parenterals, compounded products, medical devices and combination products. We perform traditional membrane filtration, closed filtration using the SteriTest system and direct inoculation. Experienced microbiologists work directly with you to ensure recovery method suitability is appropriate for each product configuration.
Our medical device sterility testing is carried out in ISO Class 3 hoods in an ISO Class 7 cleanroom. 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.
We provide endotoxin testing for the pharmaceutical, biopharmaceutical and medical device industries. This test is also known as the Limulus Amebocyte Lysate, or LAL, test. We follow USP <85> Bacterial Endotoxins Test and EP 2.6.14 as the methods to detect or quantify endotoxins that may be present in or on the sample.
The test consists of two different techniques, the gel clot LAL method, and the photometric methods. Both techniques require preparatory testing to verify that the sample solution does not inhibit or enhance the detection of endotoxins. Our kinetic endotoxin laboratory personnel are highly trained in both techniques and laboratory procedures to ensure any test glassware or apparatus used is endotoxin free or non-pyrogenic.
The gel clot tests can be a limit test or an actual assay for quantification. Endotoxin testing medical devices using the photometric techniques, turbidimetric, chromagenic gel clot method, can be conducted to an endpoint or used to determine the rate of turbidity development. We are available for consultation about test methods, laboratory procedures or challenging products.
Integrated Laboratory Services
When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.