Why Facilities Trust Our Certification Services
●CETA Registered Cleanroom Certification Professionals (RCCP-SCF) - Certified specialists for sterile compounding facilities
●NSF Accredited Technicians - Field certifiers NSF/ANSI 49 Certified for Class II Biosafety Cabinets
●ISO 17025 Accredited Laboratory - Third-party verified testing methods and quality systems
●Nationwide Service Coverage - Professional certification available throughout the United States
●48-Hour Expedited Service - Priority response for urgent compliance needs
Why Professional Cleanroom Certification Matters
Operating a sterile compounding pharmacy, pharmaceutical manufacturing facility, hospital pharmacy, or Home Infusion Pharmacy requires strict adherence to environmental standards. USP 797 and USP 800 compliance isn't optional—it's required for patient safety and regulatory approval.
The stakes are high:
✓Patient safety depends on proper environmental controls
✓ Regulatory inspections require current certification documentation
✓Facility operations require documented proof of compliance
✓The Joint Commission and State Boards of Pharmacy audits demand compliant documentation verifying certification
What Sets Our Certification Services Apart
Pharmaceutical Industry Expertise
We understand the unique requirements of sterile compounding facilities, pharmaceutical manufacturing operations, and hospital pharmacy environments. Our certified technicians work in these regulated environments daily and know what inspectors look for during compliance reviews.
48-Hour Expedited Service Available
When your facility faces urgent certification needs—audit preparation, regulatory inspection response, or operational deadlines—we offer 48-hour expedited service to meet your timeline requirements.
Nationwide Service Availability
Professional cleanroom certification services available throughout the United States. Our certified technicians bring the testing capabilities of our ISO 17025 accredited laboratory directly to your facility.
ISO 17025 Accredited Testing
Our accreditation ensures that you have above and beyond the regulatory recognition your documentation requires. When inspectors review your compliance records, they need to see testing performed by an accredited laboratory using validated methods traceable to NIST standards.
Schedule Your Certification Assessment
Cleanroom Certification Services for Regulated Facilities
USP 797 Sterile Compounding Compliance Testing
Sterile compounding facilities require documented proof that Primary and Secondary Engineering Controls maintain proper conditions for patient safety. Our USP 797 certification testing provides the compliance documentation your facility needs:
- Cleanroom Classification Testing: Particle count monitoring for ISO Class 5, 7, and 8 environments in buffer rooms and ante rooms
- Primary Engineering Control (PEC) Certification: Biological safety cabinet testing, laminar airflow hood certification, and compounding aseptic isolator verification
- Airflow and Pressure Verification: Differential pressure monitoring and air change rates
- Environmental Monitoring: Viable air sampling, surface contamination testing, media fill testing, and personnel monitoring (glove fingertip sampling)
Your certification documentation includes detailed test results, environmental condition verification, and compliance assessment against USP 797 standards.
USP 800 Hazardous Drug Safety Testing
Healthcare facilities handling hazardous drugs face additional safety requirements under USP 800 standards. Our hazardous drug containment testing protects your staff while demonstrating regulatory compliance:
- Containment Device Certification: Negative pressure verification for biological safety cabinets and compounding aseptic containment isolators used for hazardous drug preparation
- Negative Pressure Room Testing: HD-C-PEC and HD-C-SCA room pressure differentials, air change rates, and containment verification
- Alarm and Interlock Testing: Verification of safety alarms and interlock systems that protect personnel from hazardous drug exposure
- Containment Integrity Testing: Leak detection and airflow pattern verification for hazardous drug handling areas
Certification reports document proper containment controls and provide the evidence needed for regulatory inspection and staff safety programs.
Pharmaceutical Manufacturing Certification
Pharmaceutical manufacturing facilities require ongoing environmental monitoring and certification to maintain cGMP compliance and FDA approval:
- Manufacturing Cleanroom Certification:cGMP (21 CFR parts 210/211) and FDA sterile drug product guidance requires consideration of ISO 14644 classification testing for controlled manufacturing environments. Allometrics partners with you to make sure your SOPs are followed.
- Critical Zone Monitoring: Particle count verification and microbial contamination assessment in product exposure areas
- Environmental Monitoring Programs: Regular testing schedules to verify continued process control and environmental stability
- Equipment Certification: HEPA filter integrity testing, laminar flow verification, and containment device certification
Our pharmaceutical manufacturing certification services support your quality systems and provide the documentation needed for regulatory submissions and facility audits.
Hospital & Healthcare Facility Certification
Hospital pharmacies, ambulatory surgery centers, and healthcare facilities require certification documentation for Joint Commission approval and State Board of Pharmacy compliance:
- Hospital Pharmacy Cleanroom Certification: Sterile compounding area testing and documentation for inpatient pharmacy operations
- Surgical Suite Environmental Monitoring: Operating room environmental condition verification and air quality assessment
- Specialty Pharmacy Certification: Testing and documentation for specialty compounding operations serving patient populations with unique medication needs
- Compliance Documentation Support: Detailed reporting formatted for regulatory review and facility accreditation processes
Healthcare facility certification ensures your patients receive medications prepared in properly controlled environments that meet national safety standards.
Why Healthcare and Pharmaceutical Facilities Choose Our Certification Services
Regulatory Confidence Through Accredited Testing
Your facility's regulatory standing depends on the quality of your compliance documentation. Our ISO 17025 accredited laboratory provides third-party verification that our testing methods, equipment calibration, and quality systems meet international standards. By choosing Allometrics as your ISO 17025 Accredited certification provider, you gain assurance that your partners are following the highest standards available and provide you with measurement of uncertainty when you need it. Our NSF/ANSI 49 Accredited Technicians and CETA Registered Cleanroom Certification Professionals (RCCP-SCF) deliver testing that State Board of Pharmacy inspectors, FDA reviewers, and Joint Commission surveyors recognize and accept.
Detailed documentation provides the evidence needed to demonstrate compliance with USP 797, USP 800, and pharmaceutical manufacturing standards. Test reports include measured values, acceptance criteria, pass/fail determinations, and the professional assessment needed for regulatory confidence.
Patient Safety Assurance Through Professional Monitoring
Environmental controls in sterile compounding facilities, pharmaceutical manufacturing operations, and hospital pharmacies exist for one purpose: protecting patients from contamination that could cause harm. Professional environmental monitoring verifies these controls work as intended.
Our NSF Accredited Technicians and CETA Registered Cleanroom Certification Professionals understand the critical relationship between environmental conditions and patient safety. Air quality monitoring confirms your facility removes particulate contamination. Surface testing detects microbial growth before it reaches compounded preparations. Pressure differentials prevent contaminated air from entering clean areas where medications are prepared.
By utilizing our professional testing services from our credentialed specialists, you gain confidence that the medications prepared in your facility meet the safety standards your patients deserve.
Operational Assurance for Facility Management
Cleanroom environmental issues can shut down operations until corrected. Equipment failures, improper maintenance, or deteriorating conditions affect your ability to compound sterile preparations and serve your patients. Regular certification testing detects problems before they become operational crises.
Early problem detection allows planned maintenance rather than emergency shutdowns. When certification testing identifies declining performance—reduced airflow, increasing particle counts, or contamination trends—your facility can address issues during scheduled downtime rather than discovering problems during regulatory inspections or operational emergencies.
Professional certification services provide the operational visibility needed to maintain reliable cleanroom performance and avoid costly disruptions to patient care.
Audit Readiness for Regulatory Inspections
State board inspections, FDA facility reviews, and Joint Commission surveys all examine environmental monitoring documentation. Inspectors verify your facility maintains proper conditions and has proof of ongoing compliance. Missing documentation, incomplete testing, or questionable results raise concerns and can trigger enforcement actions.
Our NSF Accredited Technicians and CETA Registered Cleanroom Certification Professionals provide audit-ready documentation that satisfies regulatory requirements. Test reports follow recognized industry standards and include all elements inspectors expect: detailed methodology, calibrated equipment documentation, measured results, acceptance criteria, and professional assessment.
When your facility maintains current certification documentation from credentialed specialists working with an ISO 17025 accredited laboratory, you demonstrate the commitment to quality and patient safety that regulators expect from professional operations.
The Allometrics Advantage: Accreditation, Experience, and Expertise
ISO 17025 Laboratory Accreditation
Third-party accreditation verifies our testing laboratory meets international standards for technical competence and quality management. Our ISO 17025 accreditation provides the regulatory recognition your compliance documentation requires. Testing equipment maintains calibration traceable to NIST standards, ensuring measurement accuracy and reliability.
Pharmaceutical Industry Specialization
Our NSF/ANSI 49 Accredited Technicians and CETA Registered Cleanroom Certification Professionals (RCCP-SCF) work exclusively in regulated environments serving pharmaceutical manufacturing, hospital pharmacy operations, and sterile compounding facilities. We understand the unique challenges of maintaining cleanroom environments in healthcare settings and the regulatory standards these facilities must meet.
Nationwide Service Coverage
Professional cleanroom certification services available nationwide through our network of certified technicians. Facilities throughout the United States access the same quality testing and professional documentation regardless of location.
Regulatory Standards Expertise
Our NSF/ANSI 49 Accredited Technicians and CETA Registered Cleanroom Certification Professionals maintain current knowledge of USP 797 requirements, USP 800 hazardous drug standards, ISO 14644 cleanroom classifications, and pharmaceutical cGMP regulations. Our certification services align with the standards regulatory agencies use during facility inspections and compliance reviews.
Professional Documentation Standards
Certification reports include detailed test results, environmental condition assessments, compliance determinations, and the professional analysis needed for regulatory review. Documentation format supports regulatory submissions, accreditation processes, and facility audit requirements. Custom reporting is available for those who need it. We typically provide preliminary reports within 24 hours.
Partner with NSF/ANSI 49 Accredited & CETA Registered Experts
Serving Regulated Facilities Nationwide
Our cleanroom certification services support facilities throughout the United States:
Healthcare Facilities:
- Hospital pharmacies and compounding operations
- Ambulatory surgery centers and surgical suites
- Specialty pharmacies and infusion centers
- Healthcare systems with multiple pharmacy locations
Pharmaceutical Manufacturing:
- Sterile injectable manufacturing facilities
- Aseptic processing and filling operations
- Pharmaceutical R&D and pilot production
- Contract manufacturing organizations (CMOs)
Compounding Pharmacies:
- 503A compounding pharmacies serving local patient populations
- 503B outsourcing facilities with FDA registration
- Hospital-affiliated compounding operations
- Home Infusion Pharmacies
- Veterinary compounding facilities
Research & Laboratory Operations:
- Academic medical center research facilities
- Biotechnology research and development labs
- Government research facilities with cleanroom requirements
- Contract research organizations (CROs)
Contact Us
Contact us to discuss your facility's specific certification needs and schedule your environmental monitoring assessment.
Frequently Asked Questions
Common Questions About Cleanroom Certification
Still Have Questions?
Our Certification experts are standing by to help you select the right service for your facility.
Providing Quality Services since 1976
Take action today to ensure your facility maintains proper certification:
Contact Options:
Call for Immediate Assistance:(281) 474-3329 Speak directly with our certification team about your facility's specific needs
Request Service Online: Complete our certification request form above for detailed information about testing services and scheduling
Email Inquiry:sales@allometrics.com for general questions about cleanroom certification servicesService Commitment:
48-hour expedited service available for urgent certification needs. Standard certification scheduling available based on your facility's timeline requirements.
ISO 17025 Accredited Testing | Nationwide Service | Pharmaceutical Industry Expertise
Allometrics Equipment Calibration Services - Professional cleanroom certification and environmental monitoring for healthcare and pharmaceutical facilities since 1976