Maintaining USP and FDA compliance is essential for ensuring patient safety, meeting regulatory standards, and supporting the integrity of pharmacy operations. ProPharma Cleanrooms delivers specialized solutions designed to help hospital and health system pharmacies, compounding facilities, and cleanroom environments achieve consistent, reliable, and fully compliant microbial certification outcomes without requiring additional internal resources.
ProPharma Cleanrooms’ services are built on comprehensive regulatory knowledge and practical support in the field. Presence during the balancing and certification process helps ensure that all critical environmental parameters are validated according to best practices. In addition, thorough cleaning and disinfection protocols applied before, during, and after certification promote effective contamination control and alignment with USP and FDA guidelines.
These services are intended to simplify workflows, reduce microbial risk, and support long-term compliance strategies. Whether managing a hospital pharmacy cleanroom, compounding suite, or specialized laboratory space, ProPharma Cleanrooms offers a complete approach that aligns with operational goals and regulatory expectations.
The following services are provided:
- On-site presence during cleanroom balancing and certification
- Cleaning and disinfection protocols conducted prior to certification
- Continuous cleaning and disinfection throughout the certification process
- Post-certification contamination control to support microbial compliance
- Alignment with USP <797>, USP <800>, and FDA regulatory standards
This approach ensures a microbial certification process that is compliant with USP and FDA regulations, supporting the delivery of safe, high-quality patient care and maintaining regulatory readiness.
