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John O’Neill
Moderator
Post count: 67

If the shipper boxes don’t offer “protection” from humidity and temperature, there shouldn’t be a regulatory problem with storing the samples in them in the chambers and then sampling appropriate quantities from them. A couple of cautions with this:

1.Prior to the start of the studies, put your justification in writing that storing the stability samples in the shipper cartons does not influence stability.
2.Be careful storing cardboard containers at 5C and any chambers that maintain higher humidities. There’s a chance that you could get mold growth on the cardboard.

What do our industry colleagues have to say about this situation?