Antimicrobial Effectiveness

Ensuring Antimicrobial Efficacy and Quality of Your Products

Evaluate the ability of your preservative system to prevent and control microbial growth in your formulations with our Antimicrobial Effectiveness Test (AET) services. This service is also sometimes referred to as the Preservative Effectiveness Testing (PET). There is a risk of microbial contamination when manufacturing sterile and non-sterile aqueous products and during repeated patient use from conventional multi-dose container systems. These microbes pose a potential threat to product quality and patient safety. We are committed to delivering timely and reliable results for your antimicrobial effectiveness testing needs. Our facilities are well-equipped to handle a comprehensive range of microbiology lab analyses. Our teams have experience with a wide range of studies and product types including ophthalmic, parenteral, oral, and topical products.

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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. 

Quality Compliance & Auditing

Analytical Methods

Environmental Monitoring

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.