Home Forums General Discussion Ultra Freezer Mapping Requirements

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  • Walter Routh
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    Post count: 34

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    Question:
    Certain chamber end users are wanting to map their freezers at a tighter specification than what is recommended in the USP. I believe it’s general chapter 659 that says something like if you need to store an article at below -20°C +/- 10°C is ok. I would like to see what others are thinking and doing.

    What are your qualification test acceptance criteria for cold storage at less than -20°C?
    Rationale for this acceptance criteria?
    What Resource do you reference if any?

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