RE: How often should I have my clean room inspected?

How often do I need to have my cleanroom inspected? Any recommendations for cleanroom certification, cleanroom inspection companies?

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The cleanroom inspection frequency is dependent on your cleanroom classification and cleanroom process. More frequent inspections are required for the more stringent cleanroom classifications. Your cleanroom inspection schedule will likely be consistent with your cleanroom compliance testing schedule, which is dependent on the cleanroom classification and could require to be done every half year or full year.

  • The ISO 14644-1:2015 introduces the need of ISO 21501-4 particle counters, which assure all cleanroom certification is based on verified data accuracy and reliability.
  • Cleanroom users shall then look to ISO 21501 as a method to meet cGMP, EU GMP, ISO 14644-1, and other requirements.
  • This change to the ISO 14644-1 represents an important step in improving the accuracy of clean room contamination evaluation and aseptic process control.
  • ISO 14644-2 specifies the requirements of a monitoring plan based on risk assessment of the intended use. The data obtained provides evidence of cleanroom or clean zone performance related to air cleanliness by particle concentration.
  • This revision of ISO 14644-2 emphasizes the need to consider a monitoring strategy in addition to the initial or periodic execution of the classification of a cleanroom or clean zone in accordance with ISO 14644-1:2015
Answered on April 10, 2019.
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