Pharmaceutical manufacturers face increasing pressure to minimize contamination risks and comply with compendial requirements, such as the United States Pharmacopeia (USP), the European Pharmacopeia (Ph. Eur. or EP), and the Japanese Pharmacopeia (JP). Amid a changing regulatory landscape, increasing liability risk, and mounting testing costs, Perritt Laboratories offers risk-based environmental monitoring that moves beyond simple sampling.
Our services include strategic processes that focus on monitoring the areas we identify as the highest risk of contamination, improving data accuracy, and monitoring efficacy.
Our pharmaceutical environmental monitoring services can form the backbone of your comprehensive monitoring program:
Our data helps monitor and measure viable bioburden. We offer both active viable air sampling — using calibrated devices to capture airborne microorganisms — and passive microbial air sampling, which tracks settled microbial contaminants. Our offerings include active air sampling and settling plate sampling. We follow the Hazard Analysis of Critical Control Points protocol, identifying critical control points and preventing contamination.
Our studies show regulators that your facility’s cleaning and sanitation procedures, including clean-in-place (CIP) systems, are effective at reducing cross-contamination between batches. We prohibit microbial growth by ensuring no residue remains. Our offerings include:
We validate that a facility’s water purification and distribution system consistently produces water that meets chemical and microbiological purity standards, including compendial requirements such as USP, EP, and JP, as well as cGMP requirements for the healthcare and pharmaceutical sectors.
We also use Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols to validate water systems and verify alignment with quality requirements.
We have invested in a state-of-the-art quality system and leverage our decades of experience to deliver reliable data.
As your organization scales and cGMP requirements shift, our consulting services keep you one step ahead. We help you design and implement a defensible, risk-based monitoring plan from the ground up, both for today and for the future. We ensure it is audit-ready and tailored to your specific facility and processes.
We provide compendial microbiological testing to verify that your products meet USP, EP, and JP standards:
Perritt Laboratories is FDA-registered, ISO 17025-accredited, and cGMP-compliant, providing your monitoring data with the credentials to withstand regulatory scrutiny and meet international market expectations. Our expertise in FDA, ISO, and CPSC regulations and our up-to-date knowledge of current requirements mean you can focus on product excellence.
Our cGMP environmental monitoring services are trusted by non-sterile pharmaceutical, medical device, food, and healthcare product manufacturers. Manufacturers choose us because our name on reports carries weight with regulators and because our services are built to comply with both U.S. and international requirements.
Contamination in your non-sterile areas can pose a risk of cross-contamination, reputational damage, and recalls. If you need cGMP non-sterile Environmental Testing to help mitigate the risk, contact Perritt Laboratories.
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