As cleanroom certification experts with over 50 years of experience, we know how important it is to maintain USP 797 and USP 800 compliance in pharmaceutical compounding facilities. At Allometrics, we provide complete USP 797 & USP 800 cleanroom certification services that make sure your sterile and non-sterile compounding environments meet the strictest regulatory standards.
Our CETA Registered Cleanroom Certification Professionals and NSF Accredited Technicians bring precision to every USP 797 and USP 800 certification—delivering the comprehensive documentation your regulators demand and the technical expertise your facility deserves.
Whether you’re maintaining a hospital inpatient pharmacy, an independent sterile compounding facility, or an oncology clinic, we provide comprehensive cleanroom certification that covers primary engineering controls, buffer rooms, anterooms, and hazardous drug areas. From HEPA filter integrity testing to microbial sampling and airflow visualization studies, we ensure your controlled environment meets every USP requirement—so you can compound with confidence and pass every audit.
USP 797 & USP 800 Cleanroom Certification Services
Our comprehensive certification program addresses every component required for USP 797 (patient safety) and USP 800 (healthcare worker protection) compliance.
Environmental Control Equipment such as:
- Biological safety cabinets
- Laminar airflow workbenches
- Integrated Vertical Laminar Flow Zones
- Compounding aseptic isolators (CAI)
- Compounding aseptic containment isolators (CACI)
- Gloveboxes and isolators
- SRPAs
- CVEs
Cleanroom services:
- Buffer room and anteroom certification
- Hazardous drug preparation and storage areas
- Airborne particle counting (non-viable)
- Air change rates (ACPH)
- Room pressurization monitoring
- Temperature and humidity validation
- HEPA filter integrity testing
- Airflow visualization studies (smoke studies)
Environmental Monitoring:
- Viable air sampling (CFU/m³)
- Surface sampling of critical areas
- Gloved fingertip sampling (GFTS)
- Sample plan development
- Incubation, analysis, and identification
- Monthly sampling kit programs
Industries We Serve With USP 797 & USP 800 Certification
Our cleanroom certification services protect patient safety and healthcare worker wellbeing across the pharmaceutical and healthcare landscape including:
Hospital Sterile Compounding
- Inpatient compounding pharmacies
- Hospital operating room pharmacies
- Surgical center pharmacies
- Hospital-based oncology pharmacies
- Hospital laboratories with compounding operations
Independent Compounding Pharmacies
- Sterile compounding pharmacies
- Small chain pharmacy networks
- 503B outsourcing facilities
- Hormone therapy compounding facilities
- Radiopharmaceutical pharmacies / nuclear medicine (USP 825)
Specialized Treatment Facilities
- Oncology treatment centers and infusion clinics
- Physician-owned compounding operations
- Home Infusion Pharmacies
- Ambulatory surgical centers with compounding
- Veterinary compounding pharmacies
Whether you manage a single cleanroom or multiple compounding environments, our nationwide service network ensures consistent testing quality and documentation across all your locations.
Why Sterile Compounding Facilities Trust Allometrics
When your facility’s operating license depends on passing certification, you need more than a testing company—you need a partner who understands what’s at stake.
CETA & NSF Certified Expertise: We employ CETA Registered Cleanroom Certification Professionals and NSF Accredited Technicians for every USP 797 and USP 800 certification. This isn’t just credentials—it’s the assurance that your testing follows the industry standards regulators expect to see during audits.
ISO 17025 Accredited Laboratory: Our lab’s A2LA ISO 17025 accreditation means you can put your trust in our high standards.
50 Years of Experience: Since 1976, Allometrics has been the trusted partner for cleanroom certification. We’ve seen every regulatory change, guided facilities through countless transitions, and helped pharmacies maintain compliance through five decades of industry evolution.
Nationwide Consistency: Managing multiple locations? Our standardized protocols ensure every facility receives identical testing procedures and documentation formats—simplifying your compliance management and reducing audit preparation time.
Rapid Response Capabilities: Equipment failures and urgent certifications happen. Our nationwide network mobilizes quickly to minimize your operational downtime and get you back to compounding safely.
Our cleanroom certification and testing program provides accurate, reliable, and thorough documentation of testing results.
At Allometrics, our USP 797 and USP 800 cleanroom certification program ensures accurate, reliable, and comprehensive documentation of test results, essential for proper maintenance, operation, and regulatory compliance.
Understanding USP 797 & USP 800 Cleanroom Certification
What is USP 797 & USP 800 Cleanroom Certification?
USP 797 establishes comprehensive standards for sterile compounding to protect patient safety, covering environmental controls, personnel competency, quality assurance, and preparation procedures. [1] USP 800 focuses on protecting healthcare workers from hazardous drug exposure throughout the entire drug lifecycle—receiving, storage, compounding, administration, and disposal. [2] Certification testing verifies that your primary engineering controls, buffer rooms, anterooms, and hazardous drug areas meet these industry standards through precise testing and comprehensive documentation. We perform USP 797 & USP 800 cleanroom certification testing for facilities and equipment to verify compliance with both standards, ensuring safe compounding that protects both patients and healthcare workers.
Benefits of Regular USP Cleanroom Certification
Audit Confidence: Walk into FDA inspections, state board surveys, and accreditation reviews with documentation that satisfies every regulatory requirement. No scrambling, no gaps, no sleepless nights before inspections.
Operational Continuity: Identify equipment drift and environmental issues before they force shutdowns. Scheduled certifications prevent the costly emergency repairs and operational disruptions that come from failed surprise inspections.
Staff Safety: Verify containment systems protecting your team from hazardous drug exposure are functioning properly, reducing workplace injury risks and liability exposure.
Risks of Neglecting USP Cleanroom Certification
Regulatory Consequences: Operating without current certification violates industry standards and invites state board sanctions, accreditation loss, and potential facility closure. The cost of non-compliance far exceeds certification expenses.
Patient Safety Failures: Undetected HEPA filter leaks, inadequate air changes, or failed room pressurization can compromise sterility—putting patients at risk and your pharmacy facing liability claims.
Operational Shutdowns: Failed inspections force immediate cessation of compounding until issues are corrected and re-certified. Days or weeks of lost revenue, transferred patients, and damaged reputation.
Worker Exposure: Without verified containment controls, your staff faces potential exposure to hazardous drugs—creating OSHA violations, workers’ compensation claims, and recruitment challenges.
Your USP 797 & USP 800 Certification Questions Answered
USP 797 and USP 800 serve complementary but distinct purposes. USP 797 establishes comprehensive standards for sterile compounding to protect patient safety, covering environmental controls, personnel competency, quality assurance, and preparation procedures. USP 800 focuses on protecting healthcare workers from hazardous drug exposure throughout the entire drug lifecycle—receiving, storage, compounding, administration, and disposal. We perform certification testing for facilities and equipment to verify compliance with both standards, ensuring safe compounding that protects both patients and healthcare workers.
USP 800 is the standard focused specifically on protecting healthcare workers from exposure to hazardous drugs. It regulates the environmental controls, containment systems, and safety procedures required when preparing, storing, and handling hazardous medications—particularly chemotherapy agents and other drugs identified on the NIOSH hazardous drug list that pose risks to staff handling them. [3] We verify that containment systems like biological safety cabinets, compounding aseptic containment isolators, and hazardous drug preparation areas are functioning properly to protect your team from exposure risks.
No, USP 800 has not superseded USP 797 requirements—they work together. USP 797 continues to govern sterile compounding for patient safety, while USP 800 addresses healthcare worker protection from hazardous drug exposure. Both standards apply to facilities that compound hazardous sterile preparations. We provide comprehensive certification for both because modern compounding operations must meet both patient safety standards and worker protection requirements simultaneously.
Resources
- https://www.usp.org/compounding/general-chapter-797
- https://www.usp.org/compounding/general-chapter-hazardous-drugs-handling-healthcare
- https://www.cdc.gov/niosh/topics/hazdrug/default.html