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USP 797 Testing

Ensuring USP Compliance

We provide comprehensive USP <797> testing and certification services to help compounding pharmacies and healthcare facilities maintain compliant sterile environments. From cleanroom certification to required microbial monitoring, we ensure your facility meets all regulatory expectations and inspection standards.

USP <797> requires:

  • Bi-annual certification of cleanrooms, hoods, and primary engineering controls.
  • Monthly viable air and surface sampling in all classified areas.
  • Testing after any construction, equipment upgrades, or significant changes.

Our technicians perform on-site testing, incubate samples in our microbiology lab, and deliver clear, actionable reports to keep you audit-ready.

Comprehensive services

Our Services

Environmental Certification

  • Cleanroom & Hood Certification (every 6 months minimum, or after construction/upgrades)
  • Airflow and HEPA Filter Testing (ISO 14644 compliant)
  • Air Change Rate & Pressure Differential Verification

Required Microbial Monitoring

  • Surface and Air Sampling per USP <797> requirements
  • Incubation & CFU Analysis – Performed in our in-house microbiology lab
  • Corrective Action Support – Investigation and retesting when action levels are exceeded

Flexible Compliance Options

  • Monthly Monitoring Programs – Custom schedules and reminders so you never miss a required test
  • Self-Sampling Kits – Cost-effective option for facilities that prefer to collect their own samples
  • Remediation & Re-Testing – Fast response when certification or microbial testing fails

Your Preferred Partner

Why Choose Us for USP <797> Compliance?

SSA offers the responsiveness and service of a local provider, with the capabilities and infrastructure of a large, national company

Fastest Reports

Our average report turnaround time for the past 12 months has been 3 days for jobs without microbial testing, and 11 days for jobs with microbial testing. 99% of reports are sent within 15 days.

Turnkey Compliance Partner

We handle everything: sample collection, incubation, analysis, and reporting.

Monthly Microbial Self-Sampling Kits

Facilities can collect their own samples with our validated kits and ship them directly to our lab for analysis.

Experienced Technicians

Trusted by major health networks, pharmacies, and hospitals nationwide for reliable service and regulatory expertise.

Technician Credentials & Consistency

We send the same technician every visit, ensuring consistency, familiarity with your facility, and trusted results. NEBB and CNBT accreditations.

Personalized Service

We offer customized testing plans and free technical consultations, so you’re never just another job on the schedule.

Local Team and Support

You will be serviced by the technicians and support staff closest to your location. No routing to call-centers or far-away offices.

Responsive & Reliable

Our turnaround times, troubleshooting capabilities, and ability to dispatch multiple technicians for large jobs ensure minimal downtime.

Quality Assurance

Certifications & Accreditations

We don’t just hire technicians — we develop scientific safety experts.
With over 10 years of average experience and continuous training, our team delivers certified excellence your environment demands.

CETA / CNBT Accredited Certifiers

NSF Accredited Biosafety Cabinet Certifiers

IEST

NEBB-Certified for Testing, Adjusting and Balancing and Cleanroom Testing

ISO 9001 Certified Laboratory

Eagleson Institute

Certified Biomedical Equipment Technicians

Other Services

Cleanroom Testing / Certification

We test and certify controlled environments to ensure that your facilities are compliant with the required standards and customer specifications.

Fume Hood Testing

Testing and repair of fumehoods, laminar flow workstations, and isolators – ensuring operational safety and regulatory compliance.

Biosafety Cabinet Certification

Certification and repair of Biological Safety Cabinets (BSCs) – ensuring operational safety and regulatory compliance.

Microbiological Services

State-of-the-art environmental monitoring services provided by our laboratory to enable end-to-end management of your samples, including incubation, identification and other microbiological services to ensure compliance with USP, cGMP, and other regulatory standards

HVAC Testing, Adjusting, and Balancing (TAB)

NEBB-Certified Testing, adjusting, and balancing of HVAC systems in critical environments.

Laboratory Equipment Maintenance & Repair

We calibrate, maintain, service, and repair your analytical lab equipment. We work with you to ensure minimal equipment downtime, and ensure that your equipment is running smoothly.

Medical Equipment Maintenance, Calibration & Repair

Maintenance, inspection and repairs of biomedical and imaging equipment such as patient monitors, infusion pumps, MRI, CT, and X-ray – keeping your facility up and running to ensure patient safety.

Biomedical Test Equipment Calibration

On-site and laboratory calibration of mission-critical biomedical test equipment used in healthcare environments

Air Filters

High-quality HEPA and ULPA filters for scientific and industrial environments. We offer expert guidance to ensure the right fit for your equipment and compliance needs.