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  1. #1
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    Question Viable and non viable particle count

    Please let me know about the viable and non viable particle count in brief,

    What are the procedures to take it and why it should be done?...

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  3. #2
    Validation Expert
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    Dear Mr.Musuth

    According to cGMP regulations and practices finished product manufacturing area should be controlled from particles i.e. viable [Living microorganisms] and non viable [Not capable of living].

    Measurement of total particle count in the clean room is described in ISO 14644. Generally viable count is measuring with the following techniques settle plates, contact plates and air sampling and done by microbilogist and limits for viable count and sampling procedure is defined in ISO 14644. Non viable count controlled by HEPA filters and integrity , velocity and particle count shall be checked in once in year to evaluate the performance of HEPA filters.

    For complete guidence refer ISO 14644 guideline for clean rooms.

    Hope you go through......
    V.J.V.Prasad
    Quality Assurance Manager
    jyotiprasad_pharma@yahoo.co.in

  4. #3
    Validation Analyst
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    thanks

    V.J.V.Prasad

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