Clean Room Validation and Certification

Clean Room Validation and Certification 

Clean Rooms play a crucial role in maintaining contamination free environments for critical processes. A well-executed cleanroom testing and certification program is essential to proper cleanroom maintenance, operation and regulatory compliance APT offers comprehensive clean room testing to attain clean room certification and validation. We can do this by offering a complete package including Particle level testing, Airflow testing, HEPA filter integrity testing and room air exchange rate testing. We can also offer cleanroom construction, advice and consultation in regards to the cleanroom envelope.

For most cleanrooms the usual testing program will usually include the following testing programmCleanroom Validation and Certification

  1. HEPA filter installation leak test – This test is performed to verify that the filters have been properly installed and are free of leaks.
  2. Airflow volume, velocity, and uniformity tests – This test is performed to check the uniformity of the clean air and to verify that there is enough air supply to provide the proper room pressures.
  3. Room pressurisation test.This test is to verify that there is a proper amount of positive/negative room air pressure.
  4. Airborne particle count test – This testing verifies that the cleanroom, the personnel, and process equipment is performing to the intended clean level.
  5. Room pressurisation test – This test is to verify that there is a proper amount of positive/negative room air pressure.

Testing and Commissioning of Clean Rooms

Cleanroom Testing and Commissioning

There are many different clean room testing certifications, all of which may occur in any of three different stages:

As Built

A cleanroom certified “As-Built Facility” defines a cleanroom fully constructed and operational, with all services connected and functioning, but has no production equipment or operating personnel within the facility. This certification is most common because any failures can be immediately addressed, and corrected by the cleanroom designers and construction Companies.

At Rest

A cleanroom certified “At-Rest Facility” defines a cleanroom fully constructed and operational, with production equipment installed and operating (or operable), but has no personnel within the facility. This certification demonstrates continued compliance from the “As Built” certification. Cleanrooms that were constructed but sat idle, or cleanrooms that were modified, would require “At Rest” certification.

Operational

A cleanroom certified “Operational Facility” defines a cleanroom in normal manufacturing operations, including equipment and personnel. This certification may occur after a partial—or full—complement of equipment is installed within the cleanroom. The intent is to demonstrate continued cleanroom compliance and maintain cleanliness standards. Cleanroom management personnel will determine if, and when, the cleanroom should meet “Operational” certifications.

I hope the above information was informative. If you would like some more information in regards to our cleanroom testing service please don’t hesitate to contact Darren directly on 07775623464.

APT Cleanroom Testing provides clients with a reliable and proactive clean room testing service. If you would like to know more about our particulate testing service and/or HEPA filter testing service to cleanrooms, please don’t hesitate to contact us at:  info@airpressuretesting.net