Empowering Your Success through Trusted Microbiology Testing
Ensure the safety and effectiveness of your pharmaceutical, biopharmaceutical, or medical device product with our reliable microbiological lab testing services. With a strong focus on GMP compliance and industry standards, we prioritize accuracy in every microbiology test we perform. Our experienced professionals offer tailored solutions aligned with USP/NF, EP, JP, and client-supplied methodologies, ensuring that your unique testing needs are met. We are committed to your success and can create customized protocols that meet your specific GMP microbiology testing requirements, supporting your pursuit to advance your innovative technology and improve lives.
Our microbiology tests and services include:
- Microbial Limit Test / MLT test (Harmonized)
- Microbial Identification Test
- Bacterial Endotoxin Test (BET Test)
- Sterility Test
- Bioburden Test
- Biological Indicator Test
- Antimicrobial Efficacy Test (AET Testing)
- Particulate Matter Testing
- Sterilization Indicators Test
- Water Testing
- Clean Room/Controlled Environment Monitoring
- Surface samples
- Viable air particulates
- Total air particulates
- Compressed gases
- On-Site Sampling
- On-Site Sampling
- Client-collected samples
- Disinfectant Efficacy Testing
- Custom protocols
Testing Solutions for Your Industry
With our state-of-the-art facilities and current Good Manufacturing Practices (cGMP) we offer comprehensive microbiology testing solutions for medical device, pharmaceutical, and biopharmaceutical industries.
We offer a wide range of testing services to support the quality manufacturing of pharmaceutical products. Our capabilities include:
- Microbial limits testing (USP <61>, USP <62>)
- Sterility testing (USP <71>)
- Particulate matter testing (USP <787> Subvisible Partulate Matter, USP <788>, and USP <789>)
- Bacterial endotoxin testing (USP <51>
- Filter validations
- Container closure integrity testing (CCIT)
- USP compendial testing
Our microbiology testing services are tailored to the unique needs of the biopharmaceutical industry. With the goal of ensuring the safety and quality of biopharmaceutical products, we offer specialized testing, including:
- Microbial limits testing (USP <61>, USP <62>)
- Sterility testing (USP <71>)
- Particulate matter testing (USP <787> Subvisible Partulate Matter, USP <788>, and USP <789>)
- Bacterial endotoxin testing (USP <51>
- Filter validations
- Container closure integrity testing (CCIT)
- USP compendial testing, bioburden testing, sterility testing, host cell DNA testing, and more
Our expert team of scientists and lab technicians conducts comprehensive microbiology testing services to ensure the safety and efficacy of medical devices. With multiple locations across the U.S., we perform hundreds of rigorous tests daily. Our aim is to ensure that the medical products we test meet the highest quality and compliance standards in the industry.
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.
Additional Resources
Discover more about our comprehensive microbiology solutions by downloading our Microbiology Brochure.
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.