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Microbiology

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.

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Life Sciences Scientist Working in Laboratory. AET testing, microbiology test, microbiology lab, Bacterial endotoxin

Our microbiology tests and services include:

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.

Pharmaceutical

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
Biopharmaceutical

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
Medical Devices

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.

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Bioburden Testing

Bioburden and microbial limits testing assess the resident microbial levels in your pharmaceutical and medical device products and ensure the absence of specified pathogens. A robust evaluation of recovery method suitability validates the testing in your product matrix and supports your need for regulatory compliance, quality assurance, and overall product safety.

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Antimicrobial Effectiveness Testing

We ensure that your non-sterile, aqueous pharmaceutical formulations meet quality and safety standards by evaluating the robustness of your preservative systems following the USP <51> Antimicrobial Effectiveness Test (AET).

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Sterility Testing

Experience peace of mind with our comprehensive sterility testing services. Our dedicated team provides the highest levels of technical service and ensures the quality of your development-stage and commercial pharmaceutical products. Our services are flexible and customized during development with rigorous and robust quality systems to ensure data integrity and regulatory compliance while delivering on-time results to meet your demanding timelines and production schedules.

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Endotoxin Testing

Endotoxins are a type of bacterial toxin that can cause serious illness, especially in people with weakened immune systems. To ensure the quality of your parenteral drug formulations, medical devices, raw materials, excipients, water, water for injection, and APIs, our experts offer testing for the detection and control of endotoxins. Bacterial endotoxin testing (BET) is crucial to uphold the quality and safety of your products.

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Particulate Matter Testing

Ensure product safety and quality compliance with visible and sub particulate matter testing services for pharmaceutical, biopharma, and medical device products. Injections, parenteral infusions, solutions, and surfaces of drug delivery systems and medical devices must be free from excess extraneous undissolved particulates.

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Biological Indicator Testing

Biological indicator testing is essential to prove your sterilization process effectiveness, but the evaluation procedure can be challenging with certain products due to design or sterilization requirements.  Achieve peace of mind in your biological indicator testing requirements with our expert guidance. Our lab personnel apply the highest level of quality and attention to detail to your project to assure your biological indicator testing is successfully executed and minimizes any chance of a false positive.

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Microbial Identification Testing

By performing microbial identification, your program stays ahead of huge risks, including time-consuming inventory recalls and jeopardizing patient safety. Our team offers years of experience performing analytical testing on various drug substances, drug products, and medical devices. We apply the highest level of quality and attention to detail to our clients to assure that their microbial identification testing is successfully executed.

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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.