Regulatory Open Forum

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  • 1.  Equipment Operating Principle

    Posted 17-Nov-2014 00:11
    Can anyone help me with the following:  is the prinicple of operation for a batch hydrogenation reactor considered to be the same as that for a loop hydrogenation reactor?

    We are doing a manufacturing change which will involve chaning equipment from a batch hdrogenator to a loop hydrogenator.  

    The SUPAC manufacturing equipment addendum focuses on drug product equipment and this change is for a drug substance so (not being a chemical engineer)  I am having trouble sorting this out .

    Thanks.

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    Karen Fleshman PhD
    Dir
    Bellevue WA
    United States
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  • 2.  RE: Equipment Operating Principle

    Posted 18-Nov-2014 10:12
    Dear Karen

    The reaction rate, product dwell time, temperature, pressure and batch size are all likely to be completely different. As a result, yield and by-product profile are likely to be different (improved) too. Also, your controls are likely to be different.

    Hope this helps somewhat.
    Regards
    Siegfried

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    Siegfried Schmitt
    Principal Consultant
    PAREXEL
    Braintree, Essex
    United Kingdom
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