Maintaining a controlled cleanroom environment is critical for pharmaceutical manufacturing, compounding pharmacies, and other facilities where contamination control directly impacts product quality and patient safety. USP <797> and USP <800> establish important requirements for monitoring and managing microbial and environmental risks associated with sterile and hazardous drug preparation.

Eurofins Built Environment Testing provides environmental monitoring services to support cleanroom certification, personnel training, and ongoing compliance programs. Our testing capabilities include microbial monitoring, cleanroom assessments, and media growth promotion testing to help facilities maintain appropriate environmental conditions and meet applicable USP standards.

With experienced technical support and reliable analytical services, Eurofins Built Environment Testing helps clients identify potential contamination risks, support regulatory compliance, and maintain the quality and safety of controlled environments.

Cleanrooms are designed to control airborne particulates and environmental conditions for a variety of applications. For cleanrooms in pharmaceutical manufacturing and compounding, monitoring of viable particles requires special attention due to the ability of microbes to multiply under favorable conditions and to cause severe harm when contaminated products or preparations are ingested or injected.

USP<797> and USP<800>

The United States Pharmacopeia – National Formulary (USP-NF) institutes standards for medicines, food ingredients and dietary supplements. Within the USP-NF the general chapter USP<797> establishes best practices and regulations for the production of compounded sterile preparations (CSPs) with the goal of preventing harm caused by microbial and chemical contaminations or other inappropriate quality. Eurofins Built Environment Testing offers a wide range of microbial tests for personnel training and cleanroom monitoring including media growth promotion testing by USP<61>. The chapter USP<800> describes practice and quality standards for handling hazardous drugs (HDs) to promote patient safety, worker safety, and environmental protection.

For more detailed information on the United State Pharmacopeia, training and updates on new regulations visit www.USP.org.

Note: The general chapter USP<800> was made official on December 1st, 2019. The revised chapter USP<797> was published on November 1st, 2022 with and official date of November 1st, 2023.