USP 797 and USP 800 Cleanroom Certification
USP 797 and USP 800 compliant cleanrooms play a vital role in creating and maintaining contamination free production environments for the pharmaceutical sterile compounding industry.
Allometrics employs NSF Accredited Technicians, and CETA Registered Cleanroom Certification Professionals (RCCP-SCF) for all USP 797 and USP 800 cleanroom certification and testing services.
What is USP 797?
USP 797 is a regulatory document issued by the United States Pharmacopoeia which specifies both the procedures and environmental requirements for compounded sterile preparations (CSPs).
The USP 797 standard was created to ensure the quality and safety of compounded products. Its focus is on providing patients with medications that are of equal:
USP 797 also details additional factors, including:
- HVAC Systems
- Cleanroom Requirements
- Humidity, Temperatures and Pressure Factors
- Equipment Requirements
- Personnel Training
- Equipment Maintenance Specifications
- Approved Cleaning Solutions
- Testing Procedures
- Standard Operating Procedures
What Is USP 800?
The USP 797 standard covers all facets of sterile compounding and aims to protecting consumers. However, the need to ensure a quality work environment and to protect healthcare manufacturing personnel from hazardous drugs had been a concern for decades.
USP 800 came to exist as a direct response to this concern. While USP 797 aims to protect the patients, the goal of USP 800 is to protect healthcare workers who come in contact with hazardous drugs.
The National Institute for Occupational Safety and Health (NIOSH) defines a hazardous drug as one who displays one or more of the following characteristics in humans or animals:
- Teratogenicity or Developmental Toxicity
- Reproductive Toxicity
- Organ Toxicity at Low Doses
- New Drugs that Mimic Existing Hazardous Drugs
USP 797 Certification and Testing
USP 797 standards came into effect in 2004. Allometrics has provided pharmaceutical laboratories with USP 797 cleanroom certification and testing services from day one.
Thanks to our unique combination of field experience, our NSF Accredited Technicians and CETA Registered Cleanroom Certification Professionals for Sterile Compounding Facilities, we can provide a wide range of cleanroom testing and certification solutions for compounding pharmacies and pharmaceutical manufacturers.
Allometrics USP 797 and USP 800
Cleanroom Certification and Testing Offering
Our USP 797 and USP 800 cleanroom certification and testing services include:
- Certification and testing for ISO Class 5 Primary Engineering Controls (PECs) that include biological safety cabinets, clean air devices, laminar flow clean benches and isolators
- Certification of buffer areas and anterooms. Our testing and certification include airborne particle counting (non-viable), air exchange rates, temperature, and humidity monitoring, airflow volume and velocity profiling, room pressurization monitoring, and HEPA filter integrity testing
- Onsite videotaped airflow pattern visualization (smoke studies) of ISO Class 5 PECs under dynamic conditions
- Isolator Performance Qualification. Our tests are modified to comply with all manufacturer and industry standards.
- Airflow and pressure testing for hazardous drug preparation and storage areas
- Environmental Monitoring (EM) of PECs and SECs of both air and surfaces including sample plan development, sample collection, incubation, analysis, growth identification, and reporting
- Repair services for biosafety cabinets, clean benches, isolators, and cleanrooms
At Allometrics, we believe our USP 797 and USP 800 cleanroom certification and testing program which provides our clients with accurate, reliable, and thorough documentation of testing results is essential to proper cleanroom maintenance, operation, and regulatory compliance.
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