New Ultra Low Freezer Validation

[Kid At Heart]

We currently have an older ultra low storage freezer used to store human tissue and now have received a new one. The area where the old freezer is located is very small and there is no room for the new freezer to be validated concurrently with the old one. We have located an area for the new freezer to be validated on another floor of the hospital. The idea is to have the new freezer initial validation to be started outside blood bank with no tissue in the freezer and then when initial function is validated, move it to it's permanent home in the blood bank. At that time, we will immediately check alarms and move the donor units into the new freezer and proceed with validation plan including checking temps manually every four hours. 

 

However, there is a concern regarding moving the tissue into the new freezer prior to completion of all validation.

I would like input on perhaps a better way to handle this new freezer validation or if there are any thoughts on whether the above plan works for regulatory compliance.  

 

Note: We have formal validation plans with pre-validation medical director approval, signature, etc...

 

Thank you for sharing.

 

[R1R2]

Can you write these exceptions into the validation?  I would also include a plan B in the validation, such as a back up freezer with your blood supplier or a box of dry ice,  just in case there are problems with the freezer validation after you move it into the new location.  I would manually monitor the temps too while the validation is in progress. 

[cthherbal]

You may want to consider loading the tissues while freezer is still out of BB, and allowing both freezers to recover from the unload/load, then move it to the new BB location. It takes awhile for the temp to raise (door closed) when power is lost-unplugging and replugging in the freezer after a few minutes should not be detrimental. Then you would have your other freezer close by if you needed it.