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  • 1.  Non-Sterile Clean room standard

    Posted 28-Nov-2016 15:59
    Edited by Zain Habib 28-Nov-2016 16:03

    Hi,

    Can someone please provide guidance for setting up a Non-Sterile Clean Room Sampling booth/standard? I am only finding clean room standards with microbiological limits for biological and sterile products. Is their a clean room requirement for non-sterile medical devices? Simply, trying to figure out which microbial limits or ventilation or environmental monitoring would need to be conducted for Class A-D  non-sterile devices. The clean room sampling booth would also need to allow inspection of raw materials during sampling.

    Looking at ISO 14644, EU GMP Annex 1 Clean Room Classification.. I am unable to find anything on non-sterile clean rooms.

    Any help would be appreciated.

    Thanks.

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    Zain Habib
    United States
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  • 2.  RE: Non-Sterile Clean room standard

    Posted 19-Dec-2016 20:28

    Hi Zain,

    This might help found this ppt presentation from July 2015 Regulatory Education for Industry-Facilities and Equipment CGMP by Brown and Nguyen.    Carmen M. 

    http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm456370.pdf

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    Carmen Marquez
    Chicago IL
    United States

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