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  • 1.  CCIT - sterile injectable

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jan-2020 10:40
    This message was posted by a user wishing to remain anonymous

    All,

    Does CCIT per USP<1207> have to be performed on all product vial sizes?  If there are only two vial neck sizes, can one vial size per neck size be used?  We are currently looking into the dye ingress with vacuum method.  I would appreciate any help with understanding USP<1207> CCIT and what the Agency finds acceptable. 

    Thank you