Qualification of a Temperature Controlled Unit have to be empty?


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Hello everyone.

I'm currently trying to qualify (IQ/OQ) a cold room in our facility. However, we've been using this unit to store product even though it is not qualified and now we are qualifying it retrospectively.

There is product stored in the cold room, however, the owner of the cold room will not remove product because we have no other unit to store the product that is currently in cold room.

My question is, can we still qualify the unit even with product stored in the unit? I was thinking that having product inside the cold room would be a worse case scenario compared to an empty chamber because it'll stress the unit harder to have it hold a certain temperature.

Would love people's thoughts on this. Thank you in advance!

Ronen E

Problem Solver
Worst case scenario would be when you fill up the cool room with warm products.

IQ should be based on the cool room's manufacturer's specifications and instructions. There's no one magic formula.

I'm not an expert on cool rooms but I would imagine there must be at least one published standard for their establishment, commissioning and operation. That's what I'd look for.



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I can't answer for sure, but I would think this would be like validating a temperature chamber - You do it with the expected load, not empty.


The very first place to start would be your written requirement for storage and a little time thinking about its application. Does the room require uniform temperature or is it acceptable to have differing temperature zones as long as the product remains within the tolerance band of the required temperature.

Second place to look would be any specifications associated with the product requiring cold room storage such as ANSI, AMS, or ASTM, etc. These specifications will sometime define a storage requirement and then reference an associated requirement to the storage equipment. Another source could also be the manufacture of the product or product associations like the Rubber Manufactures Association (RMA).

Also don’t over think the qualification because it will be retrospective, so:

Installation Qualification: Review equipment manufactures requirements for installation of the equipment from the user’s manual and write these as the requirements that must be verified. Second part of IQ would be calibration of temperature controllers, thermocouples, monitoring equipment etc.

Operational Qualification: Because this is a retrospective qualification it could just as easily be the current “as found condition” with mapping of the temperature zone. Again OQ would be based on your needs of the organization, your written requirements and maybe published specification.


Funny, I was just having this discussion for a small refrigerator, the vendor wants to conduct the PQ with the unit empty and full. To me the full unit will not really cover the robustness since the materials will help it maintain the temperature and I'm not really seeing airflow as a concern in a small unit. As far as the walk in unit being full, the airflow maybe depending on the placement, but then you are qualifying what size materials and locations they can be placed in correct? At my previous company we had 4 full cold rooms with in-process and finished goods. We wrote a note to file to our validation that the room will be mapped with product in it and the ISO 13485 auditor didn't have a problem with it at all. We never had the FDA come in, the product was an ASR IVD with ISO and FDA registrations.

Anyone else have thought on this?
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