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  1. #1
    Validation Analyst
    Join Date
    Jun 2011
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    3

    Default Clean Equipment Hold Times

    Fermentors have been sitting clean for 6 months. Would like to do a CEHT. What criteria would you suggest? Is it a waste of time to do micro testing since when used next fermentors are sterilized with sufficient lethality to kill anything of concern.

    Appreciate some advice

    Thx

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  3. #2
    Validation Guru
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    Oct 2010
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    Default

    What is the basis that they are sitting clean? Do you have documental evidence?

    Sitting clean means : Visually clean Or In a clean place Or cleaned and kept Or Periodically Cleaned or Tested regularly for Physical, Chemical and Microbila limits?

    Do you know how impeller is mooving after keeping them quiet for a long time?

    Do you find any physical changes on SS metal on the inner parts?

    Did you perform swab test on various ports, impellers and other places in the fermentors?

    Did you charecterise the residues on the day you stored?

    Do you know potential dead legs exist and what is the condition there?

    It should be validated in to totality. Nothing is certain about these critical equipment once you stop using.

    It sounds harsh but the truth is they often fail.

    Regards
    Durga Prasad

  4. #3
    Validation Analyst
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    Jun 2011
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    Equipment is under a cleaning validation protocol. Swab and rinse samples for residual product were performed after last use as well as visual inspection. The equipment was started up and tested mechanically every month. Aside from the mechanical what would be acceptable requirements for Chemical and Microbial limits in a CEHT study.

    Sharon H.

  5. #4
    Validation Guru
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    Its good. If it is commercial size fermentor --more than 100L you can do one test by filling the media and keeping it for 24 hours and conduct a microbial test by drawing samples.
    This proves many points.
    Durga Prasad

  6. #5
    Validation Analyst
    Join Date
    May 2012
    Posts
    6

    Default

    Dear all
    for established the clean equipment hold time the equipment kept in controlled enviorment conditions. Microbiological swab sample are collected from different locations of equipments which are previously defined in protocol (Hard to clean locations) at a reqular interval of time defining in the protocol. there is no need to perform any chemical analysis for previous residue if cleaning procedure is already validated.

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