Validate Product Safety & Process Efficacy
Ensure the quality of your starting materials and the safety of your pharmaceutical and medical device products by assessing the microbial levels present and confirming absence of pathogens. We have expertise in a wide range of raw materials and product dosage forms. Our experienced microbiologists work closely with you to ensure the recovery methods are appropriate for the material/dosage form and are consistent with established specifications. We are also able to follow your lab’s established methods when needed.
Our Microbial Limits Testing (MLT) meets the requirements of the United States Pharmacopoeia (USP) general chapters <60>, <61>, and <62>, and harmonize with the requirements of European Pharmacopoeia (EP) general chapters 2.6.12 and 2.6.13. Additionally, our bioburden test procedure is performed in accordance with ISO 11737-1:2018 to determine the population of viable microorganisms in or on a pharmaceutical product, medical device, or component prior to sterilization.
Integrated Laboratory Services
When your team needs additional support, our scientists are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
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.