Certification Testing

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Cleanroom Testing and Certification

Cleanrooms are controlled environments designed to limit airborne particulates and provide other environmental conditions that address contamination and safety. Cleanrooms are certified to a specific class based on ISO standards and/or similar standards (U.S. Pharmacopeia/USP for pharmacies). The room must perform in a way that meets or exceeds the ISO parameters to maintain compliance.

Cleanroom certification testing involves checking that the cleanroom is functioning to the specific parameters and ISO classification. The room is initially certified when originally constructed. The room is then routinely recertified (annually or semiannually) or after any contamination incident to ensure the environmental quality parameters have not changed during occupancy.

Compliance Certification Testing addresses the room and the equipment in that room. Compliance Certification Testing verifies airflows, room design, pressurization, HEPA integrity/leaks, non-viable and viable sampling, temperature and humidity, deep cleaning, training, consulting, repairs, air balancing and documentation.

Laboratory Certification and Testing

A laboratory is a facility that provides controlled conditions in which research, experimentation, testing and analyses are performed. Laboratories are defined by risk level, or Biosafety Levels (BSL) 1 through 4, which are ascending levels of containment defined by the risk criteria of infectivity, severity of disease, transmissibility and the nature of work performed.

Each level of containment describes its microbiological practices, safety equipment and required facility safeguards, with the highest risk level (BSL-4) requiring the most certification testing. Compliance Certification Testing can include airflow assessment, room design, pressurization, HEPA filter status, HVAC system performance, building automation calibration and sequence of operations verification, alarm notifications, infrastructure inspection and equipment (fume hoods, biological safety cabinets, flow hoods) certification with consulting, repairs, air balancing and documentation.

Our Certification and Testing Services

CEPro is the only certification company you need for pharmacy cleanroom and laboratory space certification services. Our extensive experience with the design and construction of pharmacy compounding spaces to meet the requirements of USP Chapters <797> and <800> makes CEPro uniquely qualified to test your pharmacy compounding and laboratory areas as well as respective equipment.  Our thorough understanding of the operational infrastructure found in these complex facilities provides a unique opportunity to address remediation items and failures, needing repair, in an expeditious manner.

At CEPro, our professionals possess an in-depth knowledge of cleanroom function and maintenance. That, combined with a thorough understanding of pharmacy compounding space regulatory requirements, allows us to provide a service that not only meets your operational needs but also considers life cycle issues that impact ongoing maintenance and certification costs and requirements.

Our services include:

Cleanroom Certification – Area Certification

  1. Airflow Testing
  2. Room Segregation/Design
  3. Room Pressurization
  4. HEPA Challenging/Leak Testing
  5. Temperature, Pressure and Humidity Sensing Calibration
  6. Monthly surface sampling kits
  7. Incubation reporting of other kits
  8. Fingertip testing
  9. Remediation Plan Development and Implementation
  10. Challenge port installation

Cleanroom Certification – Equipment

  1. Airflow Velocity Testing
  2. HEPA Integrity Testing
  3. Dynamic Airflow Smoke Pattern Test with Video
  4. Viable Air & Surface Testing

Laboratory Space & Equipment Certification

  1. Airflow pressurization Test & Balance
  2. Fume Hood/BSC/Equipment Certification
  3. Building Automation System commissioning
  4. ASHRAE 110

BSL Laboratory Space & Equipment Certification

  1. Decontamination
  2. Mechanical Systems Inspection
  3. HEPA Exhaust System Certification
  4. Bubble Tight Damper function testing
  5. Exhaust and Supply Air Valve function testing
  6. Airflow, Air Change Rate, Pressurization verification
  7. BAS/Controls Function testing
  8. HEPA filtration challenge
  9. Document Fan System Performance data
  10. Local Alarming Indication
  11. Equipment Certification
  12. Project Management

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