A: This depends upon your quality assurance procedures. Most people test annually. Some industries like pharmaceutical manufacturing do clean room testing and certification every 6 months. However, anytime you have reasonable cause, you should have your cleanroom tested. For example, you just completed an area expansion or there was a contamination event.
A: Our engineers and technicians are experts on cleanroom testing and certification. Our equipment is calibrated annually with NIST traceable standards. We don’t use hand held particle counters. Our bench-top equipment ensures you get accurate results.
A: Yes – we travel nationally and to Mexico to do cleanroom certifications.
A: We will do our best to accommodate you.
A: It depends how many rooms we need to test. We take a minimum of 10 particle counts per room, so budget at least 20 minutes per room.
A: The room should be thoroughly wiped down before testing. If possible, we recommend that the room be left vacant for at least 2 hours before the test. No operators should be working in the vicinity of the area being tested.
A: The report will describe the room(s) being tested, equipment used to test the room, and test results. In addition, the cleanroom certification report will include recommendations on needed maintenance or procedures to help maintain the room at desired class.
A: We only certify cleanrooms. We do not certify equipment.
A: American Cleanroom Systems does particle testing to certify cleanroom class. We do not provide FDA certification or validation.
A: DOP testing is cleanroom HEPA filter integrity or leak testing. Dispersed Oil Particulate (DOP) is injected into the upstream air flow into the HEPA filter. A photometer is used to detect if and how much DOP is making it thru the HEPA filter.
A: Cleanroom HEPA fan filter units can be ordered with surface test ports that allow testing company to inject DOP from inside cleanroom.
A: Cleanroom viable testing is for live microbial and mold growth. Typically settling plates or swabs are used to collect samples to be incubated. Non viable testing is for dead particles. Laser particle counters are used to measure particle size and quantity per cubic feet. ISO 14644-1 cleanroom classifications use non viable particle counts.
A: Air flow testing is used to verify that the cleanroom HEPA filtered air changes per hour are sufficient to meet class. Field testing is done with hood manometers are veligrid air velocity tools.
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