Cleanroom Certification & Testing

ISO Class 1-9 cleanrooms are required per ISO 14644-2:2015 to be certified at a minimum time interval of once per year. ACM's certified technicians follow ISO procedural standards and serve the Medical Device, pharmaceutical, Aerospace, and Semiconductor industries. ACM will perform Cleanroom Certification and Testing for FFUs, Biological Safety Cabinets (BSC), fume hoods, laminar flow benches, and isolators.

Trust your cleanroom to the experts in the business, contact us, and speak to our engineer for a consultation on how ACM can best help with your cleanroom certification and testing needs.

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Primary Certification Tests

  • Airflow Volume/Velocity Readings With Room Air Exchange Rate Calculations
  • Filter Challenge/Ambient Air
  • Filter Challenge/Aerosol (PAO or PSL)
  • Room Pressure Differential Measurements
  • Hepa Filter Integrity Test
  • Non-Viable Particle Counting
  • Temperature / Relative Humidity Measurements

Other Services

  • Air Laminarity Visualization Test
  • Filter Leak Repair
  • Filter Replacement
  • ESD Surface Conductivity Testing
  • Molecular Air and Surface Testing
  • Lighting, Vibration, and Noise Tests
  • Viable Air and Surface Sampling with Total Numerology or Gram Stain results

Custom EM Program Features

  • Establish static and dynamic monitoring times and locations
  • Use calibrated instruments and media within expirations
  • Sample air and surfaces for viable bio-burden
  • Sample water and steam lines
  • Incubate samples according to ISO 14648 or the customer’s SOPs
  • Count, record gross morphology, and, as required, Gram stain
  • Perform species identification as requested.
  • Test air and nitrogen lines and send sampling canisters out for testing.
  • Perform trend analysis. Trend analysis will be sorted by Gram staining, gross morphology, quantity, and locations. Species identification will be performed as required and included in the trending chart.
  • Input data into customer software.
  • Participate in investigating excursions as requested or required.

For Effortless Compliance, trust the Environmental Monitoring of your cleanroom to the experts in the business. For more information on EM testing procedures, see below. You may also contact us and speak to one of our dedicated professionals for a consultation on how ACM can best service all your cleanroom needs.

What Does ACM Monitor?

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High contact equipment such as tabletops, process equipment, walls and floors are monitored regularly to ensure that the cleaning program is consistent and compliant.

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Personnel are monitored to assess the effectiveness of the gowning program. A qualified person uses contact plates to monitor areas of the gowned body that may interact with the sterile field or product exposure areas. These may include gloved hands, forearms, or other areas.

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Air samples are measured in two ways: the first by drawing in predetermined volumes of air over a sterile growth plate and the second by exposing growth plates to the environment for a specific period of time.

A Hepa HVAC system can account for 99.97% of all of the non-viable and viable particulates throughout the controlled area; the remaining 0.03% will settle and contribute to Alert and Action levels.

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Surfaces are monitored to measure the effectiveness of the cleaning program. High-contact equipment such as tabletops, process equipment, walls and floors are monitored regularly to ensure that the cleaning program is consistent and comprehensive.

ACM will help your manufacturing facility develop a Environmental Monitoring Program as a proactive way to ensure cleanliness is maintained.