Ensuring Antimicrobial Efficacy and Quality of Your Products
Performing Preservative Efficacy Testing
Our expert teams follow the antimicrobial efficacy test procedures outlined in EP 5.1.3 and USP <51>. While evaluating the Suitability of Recovery Method, we carefully inoculate product aliquots with the prescribed panel of challenge organisms specified in the USP / EP compendia and add challenge house flora monitored from your facility environmental monitoring programs. Additional challenge organisms can be used at your request.
By introducing these challenges into the formulated product, we monitor any changes to assess the effectiveness of the preservative system in preventing and reducing microbial growth over a period of 28 days.
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.