Radiopharmacy operations demand precise environmental control. USP 825 establishes the standards for facilities preparing sterile and non-sterile radiopharmaceuticals—balancing patient safety through contamination control with worker safety through radiation protection.
Since 1976, Allometrics has provided USP 825 cleanroom certification services that help healthcare facilities maintain regulatory compliance. All certification services follow industry-standard methodologies including those established by CETA (Controlled Environment Testing Association) and equivalent guidelines. Our testing verifies that your controlled environments meet the air quality, pressure differential, and particulate standards required for safe radiopharmaceutical preparation.
We serve nuclear pharmacies, hospital nuclear medicine departments, and specialty clinics nationwide. Our field service teams understand the unique challenges of radiopharmacy environments—from hot cell configurations to ALARA principles—and work efficiently to minimize disruption to your operations. [1]
When State Boards of Pharmacy or regulatory agencies review your documentation, you need defensible data from qualified sources. We deliver the technical precision and comprehensive reporting that supports your compliance program.
USP 825 Cleanroom Certification Services We Provide
Environmental Certification Services for Radiopharmacy Facilities
USP 825 establishes requirements for facilities and engineering controls used in radiopharmaceutical preparation. We provide comprehensive environmental testing to verify your controlled environments meet these standards.
Our Certification Services Include:
Primary Engineering Controls (PEC) Certification: We certify the ISO Class 5 environments required for sterile radiopharmaceutical preparation, including:
- Laminar Airflow Workbenches (LAFW) with vertical unidirectional airflow
- Biological Safety Cabinets (BSC) Class II
- Hot-cells with integrated HEPA filtration systems
- Other primary engineering controls providing ISO Class 5 air quality
Classified Area Certification: We verify air quality standards for buffer areas and ante-rooms according to ISO classification requirements:
- Buffer area testing (ISO Class 7 or cleaner)
- Ante-room testing (ISO Class 8 or cleaner)
- Air changes per hour (ACPH) verification
- Pressure differential monitoring between classified areas
Segregated Radiopharmaceutical Processing Area (SRPA) Testing: For facilities using unclassified SRPA configurations, we verify the PEC maintains ISO Class 5 conditions and test airborne particle counts when required.
Environmental Testing Services:
- Airflow Pattern Analysis – Smoke studies demonstrating unidirectional airflow in primary engineering controls under dynamic conditions
- HEPA Filter Integrity Testing – Verification that filtration systems maintain required particle removal efficiency
- Particle Count Testing – Viable and non-viable particulate sampling to verify ISO classification
- Pressure Differential Testing – Verification of pressure relationships between classified areas
- Temperature and Humidity Monitoring – Environmental condition verification
Documentation: All certification services include comprehensive reports with test data, acceptance criteria, instrument calibration records, and referenced methodologies suitable for regulatory review.
Facilities and USP 825 Practice Settings We Serve
USP 825 applies to all practice settings where radiopharmaceuticals are prepared, compounded, dispensed, or repackaged. We provide environmental certification services for these facilities:
- State-Licensed Nuclear Pharmacies
- Federal Nuclear Pharmacy Facilities
- Hospital Nuclear Medicine Departments
- Nuclear Cardiology Clinics (fixed site or mobile)
- Specialty Clinics preparing radiopharmaceuticals
- Other Healthcare Facilities handling radiopharmaceuticals
Our certification services support compliance for facilities where authorized nuclear pharmacists, authorized user physicians, and personnel working under their supervision prepare and handle radiopharmaceuticals.
Our cleanroom certification and testing program provides accurate, reliable, and thorough documentation of testing results.
At Allometrics, our USP 797, 800, and 825 cleanroom certification program ensures accurate, reliable, and comprehensive documentation of test results, essential for proper maintenance, operation, and regulatory compliance.
Why Radiopharmacies Choose Allometrics for USP 825 Certification
Five Decades of Controlled Environment Testing
Radiopharmacy certification requires specialized knowledge. Since 1976, we’ve built expertise in controlled environment testing for healthcare facilities with complex regulatory requirements.
What Sets Our Service Apart:
Our laboratory maintains ISO 17025 accreditation—the international standard for testing competence. This credential demonstrates our technical capabilities and quality systems meet rigorous standards. Every instrument we use is calibrated with NIST traceable standards through our ISO 17025 accredited calibration services, ensuring measurement reliability for all USP 825 testing.
We serve facilities nationwide, coordinating testing around your production schedules to minimize operational impact. Most certifications are completed in a single site visit.
Why Healthcare Facilities Trust Us:
- Specialized experience in radiopharmacy and nuclear medicine environments
- Comprehensive documentation that satisfies regulatory inspections
- Responsive service for routine certifications and urgent compliance needs
- Technical support to help you interpret results and address questions
Our team understands both the contamination control requirements that protect patients and the radiation safety considerations that protect your staff.
Our USP 825 Cleanroom Certification Process
What Is USP 825 Cleanroom Certification?
USP 825 establishes standards for radiopharmaceutical preparation environments. [2] This chapter addresses both sterile and nonsterile radiopharmaceuticals, with particular focus on the controlled environments needed for preparation, compounding, and dispensing.
Certification verifies that your facility meets these environmental standards through systematic testing of air quality, airflow patterns, pressure differentials, and particulate levels. This documentation demonstrates compliance to regulatory authorities including state boards of pharmacy and other oversight agencies. [3]
Benefits of Professional USP 825 Certification
Regulatory Compliance: Independent third-party certification provides objective verification that regulatory agencies expect.
Risk Management: Identifying environmental deficiencies before regulatory inspections gives you time to correct issues without operational disruption or citations.
Staff Protection: Proper environmental controls protect pharmacy personnel from both contamination and radiation exposure—core requirements of any radiopharmacy safety program.
Operational Confidence: Regular certification provides assurance that your primary engineering controls, buffer areas, and ante-rooms maintain the air quality standards needed for safe radiopharmaceutical preparation.
Risks of Inadequate Environmental Monitoring
Facilities without current certification documentation face several risks. State and federal boards take radiopharmacy compliance seriously—violations can result in operational restrictions or license issues. Environmental control failures that go undetected create cumulative patient safety risks. Inadequate containment may expose staff to radiation levels exceeding permissible limits, creating workplace safety concerns and potential regulatory findings.
Schedule Your USP 825 Cleanroom Certification Today
Maintain your radiopharmacy compliance with professional environmental certification. Our field service teams serve facilities nationwide, working around your production schedules to minimize disruption.
Contact Allometrics Today:
Phone: (281) 474-3329
Monday–Friday, 8:00 AM – 5:00 PM Central Time
Address:
Allometrics, Inc.
1425 Atlantis Drive, Suite B
Webster, TX 77598
Request a detailed quote for your facility’s certification needs. Most assessments are completed in a single site visit with comprehensive documentation delivered promptly.
USP 825 Cleanroom Certification: Frequently Asked Questions
USP 825 establishes standards for facilities preparing sterile and nonsterile radiopharmaceuticals. We verify your controlled environments meet air quality, pressure differential, and particulate standards, including ISO Class 5 conditions for primary engineering controls, ISO Class 7 or cleaner buffer areas, and ISO Class 8 or cleaner ante-rooms.
Nuclear pharmacists, authorized user physicians, and personnel working under their supervision are authorized to compound, prepare and handle radiopharmaceuticals. We provide certification services supporting compliance for all facilities where these authorized personnel prepare, compound, dispense, or repackage radiopharmaceuticals in any practice setting.
You can find a local USP 825 cleanroom certification provider for your facility by contacting Allometrics Inc. We provide USP 825 cleanroom certification services to local facilities throughout the 50 states, with field service teams coordinating testing around your production schedules. Established 1976, we have been your local cleanroom certification and ISO 17025 accredited calibration experts for over 50 years. Contact us at (281) 474-3329 for certification services at your location.
Resources
- https://www.nrc.gov/reading-rm/basic-ref/glossary/alara
- https://www.usp.org/frequently-asked-questions/radiopharmaceuticals
- https://crcpd.org/about-us/