Home Forums General Discussion Drug Substance “Drum Stability” in miniature simulated packages

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  • John O’Neill
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    Posted by Editor in behalf of Amy Clark-Stasiw

    I have a client that is trying to store their DS in the same container that it is stored in the warehouse. They are having trouble locating an HDPE drum that is comparable. In my experience – as long as the HDPE bottle/drum is made of the same resin/colorant – they should be good to go. The drums in the warehouse use clamps to close the lids – the smaller versions they have been able to find are either screw cap or snap on. Is this a reasonable way to store the DS for stability studies?

    Response by John O’Neill

    In my experience, using smaller containers of the same makeup has been acceptable. A possible point of contention would be if they had justification that the closures presented similar barriers to moisture and that the miniature did not provide a much tighter seal.

    Reply by Amy Clark Stasiw

    Thanks for the reply. It is the same response I have received from others. Please do share it on the forum page for others to discuss.

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