Changes to GMP force cleanroom re-classifications

Cleanroom users claiming compliance to cGMP and/or GMP will have to consider a new rule, ISO 14644-1:2015, when next re-qualifying their cleanrooms, potentially purchasing new air particle counters if their existing counters do not comply with the new performance rules and facing the dilemma that the new re-qualification may indicate that their cleanroom is not operating at the grade they had achieved using the old classification process.

The ISO 14644-1:2015, published on December 15, 2015, contains substantial revisions impacting both the way the cleanrooms are classified and the performance requirements of the air particle counting instruments used to carry out the classification. This paper explains the new rules.

Download this whitepaper & learn about:

  • Understand how changes to ISO 14644-1 are possibly the biggest change to GMP cleanrooms since 2003!
    Get details of the four fundamental changes in ISO 14644-1:2015 impacting the GMP community
    Understand the implications of these changes on cleanroom classification/re-qualification SOPs
  • Understand the new method for calculating the number of sample locations and much more!
  • Proactively plan for these changes now rather than wait till your next inspection

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    • Vivekanand Ramchandra Bhogale

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