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  1. #1
    Validation Analyst
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    Default Humidity control for empty gelatin capsule

    Dear All,

    Is it necessary to store empty gelatin capsule under humidity control, if yes then what is the justification??

    Kindly response on urgent basis.

    Regards

    Prashant Mhetre

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  3. #2
    Validation Guru
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    Default

    The ideal humidity is between 45% to 55%.

    If you store in higher humidity the hard gelatin capsules will soften and you will get loads of rejections.There is every possibility that will soften and lose their shape.

    If you store in lower humidity conditions than specified they might get shattered on the machine. The reason is they get slightly smaller in size after losing certain moisture in them.

    Temeperature too is a critical factor. You must store around 20C.

    Regards
    Durga Prasad

  4. #3
    Validation Analyst
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    Default

    Dear sir,

    How to dispense the empty capsules? Is Dispense the capsules the numbers or weight besis?

    and incase after manufacturing remaining empty capsules,Is return to stores throgh MRN...? OR are distruct the capsules ? plz clarify as soom as possible sir ?


    THANHS IN ADVANCE ,

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