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Cleanroom / HEPA / Laminar / Flow Certification

Cleanroom / HEPA / Laminar / Flow Certification

Testing and monitoring of your Cleanroom, HEPA filters, and Biological Safety Cabinets/Laminar Flow Hoods/Clean Benches/Fume Hoods must occur on a routine basis to guarantee personnel safety and reduce risk of product contamination.

Quality Solutions can create a testing protocol for the certification of your Cleanroom while providing the necessary testing services to manage the certification and on-going monitoring. Protocols include qualification of supporting utilities and equipment such as air handlers, building monitoring systems, air, and water systems.

Cleanroom certification consists of:

  • HEPA filter leakage testing
  • Airflow velocity and volume testing
  • Ambient light and noise levels
  • Room differential pressure testing
  • Visual airflow characterization
  • Room temperature and humidity testing
  • Viable surface and air sampling
  • Non-Viable air sampling

Quality Solutions manages the analysis of room data, provides viable plate enumeration, and coordinates the microbiological identification of bacterial and fungal organisms.

Once room certification takes place, we can provide on-going routine monitoring services needed to maintain compliance as part of an environmental monitoring program. We can provide support for the development of Cleanroom procedures, alert and action limits, training programs, and ongoing environmental testing.

In addition, Quality Solutions uses only NSF (National Sanitation Foundation) Certified Engineers to conduct all HEPA and Certification testing. Our certifying engineers and technicians are NSF accredited with a combined 25 years of experience in testing, troubleshooting, repairing, and decontaminating laboratory equipment.

With this diverse experience our engineers and technicians can handle the newest advances in Biological Safety Cabinet technology and add value by sharing our experience with clients.

Quality Solutions

Quality Solutions News & Announcements

Founded in 2001 as a validation services provider, Quality Solutions has grown into a leading compliance and support partner for the biotech, healthcare, and pharmaceutical industries. With offices in Maryland and Utah, we execute projects both nationally and internationally, offering tailored, cost-effective solutions to meet FDA regulations, USP 797/USP 800 guidelines, and broader quality management needs. Our comprehensive services—including facility design, calibration, validation, and environmental certification—ensure seamless compliance and operational efficiency. With an integrated certification team and in-house lab, we deliver fast, reliable results, minimizing risks and costly delays. At Quality Solutions, we take a long-term partnership approach, acting as your insurance policy for maintaining compliance while maximizing the financial return on quality investments.

RXinsider Staff

Posted by: RXinsider Staff

RXinsider is a multimedia publishing and technology company offering print publications, digital platforms, events, and content creation services to the B2B pharmacy market.

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