Posted for a Subscriber
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?