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  • 1.  Pure Water for Sterilization process in Autoclave

    Posted 09-May-2022 11:56
    Hi All
    What is the FDA requirement for reuse the pure water coming out from a super-Heated sterilization (121 °C)system  in a Pharmaceutical facility manufacturing IV Bag and how many times can we use before replace that water, is it every 8 hours shift or per day or per batch

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    YASSER ESTAFANOUS
    Chief Quality & Regulatory officer
    Winter Haven FL
    United States
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  • 2.  RE: Pure Water for Sterilization process in Autoclave

    Posted 13-May-2022 02:34
    Edited by Sanket Shah 13-May-2022 02:36
    Hi YASSER ESTAFANOUS, 

    As per my knowldge criteria for reuse of pure water ( which is came out of sterilisation 121 C) was not observe in FDA compliance manual 7356.002A , USFDA 2004 Sterile manufacturing guidance.

     If plan to reuse purified water , then care should be taken as below - 
    a) It should not compromise intent purpose of terminal sterilisation cycle and its validated parameters.
    b) Quality of pure water and recriculated pure water is to be same. If quality may compromise then its impact to be evalauted though validation of terminal sterilisation loads and that reusage limit of purified water is to be established.
    c) Performance of equipment ( sterilser) is to be assessed periodically to ensure , reuse of water implies any adverse impact or not.
    d) Impact on material of construction and labels of IV bags to be ensure.
    e) Sterility assurance level and product quality is should not be compromise. 

    In view of water resource managment , cost to operation and utility management - pharmaceutical industry has been implemented resue of different grade of waters at different stages of operations as appropriatly by considering quality impact and compliance.

    Thats all from my end.



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    Sanket Shah
    Auditor QA
    mumbai
    India
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    Original Message


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