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CFU count for DI water sample

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Airwolf, Sep 20, 2019.

  1. Airwolf

    Airwolf New Member

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    Hi guys

    I was unsure where to put this question -- so here goes.

    I have something called an "ELMA" cleaning line, which has several vats for cleaning medical devices. The final vat is deionized water, which is fed from something called an "ELMApur85", which also employs UV-light for antimicrobial effect. I want to check the CFU count in the water in the final vat, but I cannot find anything regarding the limits of CFUs in deionized water - as deionized water is many things :)

    Is there a guideline or other official information that has 'real' numbers, or just a recommendation?

    Thanks for reading!
     
  2. Sam Lazzara

    Sam Lazzara Member

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    In the USP (US Pharmacopeia) there are 2 monographs I am aware of related to water - one for Purified Water (PW) and one for Water for Injection (WFI).
    And USP General Chapter <1231> WATER FOR PHARMACEUTICAL PURPOSES is very informative.
    WFI-USP has to be sterile, so no CFUs are allowed. For PW-USP there are 2 versions, Sterile and Non-Sterile, I believe, and I expect the Non-Sterile version would have CFU limits.
    The attached images, gathered from the internet recently, may be interesting for you.
     

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  3. Sam Lazzara

    Sam Lazzara Member

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    Here are 2 more images.
     

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