new refrigerators

[Tony R]

Can any one tell me if the CAP has any special requirements dealing with installation of new refers in blood banks? Our maintenance dept. checks the electronics and compressors and such. My gut feeling is that they may require the temperature sensors be calibrated against a NIST thermometer. Any help is appreciated.

Tony

[David Saikin]

You should have a validation plan for installing new equipment. CAP does not define what needs to be done.

[C Lumbert]

After the installation validation, it is a good idea to perform maintenance according to the manufacturer's instructions (per FDA Regs).

Our interpretation of the thermometer calibration requirement is that all thermometers should be calibrated against an NIST certified thermometer initially, then according to your company policy.

______________________

Chuck Lumbert, MT(ASCP)

[adiescast]

Generally, the point of validating new equipment is to show that it will work properly in your environment. Validation involves three phases (usually): installation, usually performed by the manufacturer, shows that the equipment is properly installed according to the manufacturer's requirements; operational, sometimes performed by the manufacturer at installation, shows that the equipment is functional to the manufacturer's expectations when it was installed; and performance, usually done by the customer, shows that the equipment performs according to the customer's requirements under their local conditions. For a refrigerator, you would want to see that it meets the requirements for maintaining a stable temperature under normal working conditions in your lab. Do you open the doors often or for long periods, what is your alarm range and does the alarm sound when it is supposed to, what else happens to the refrigerator when the alarm is activated, is the thermistor reading the internal temperatures accurately, are the fans circulating air properly when the refrigerator is fully loaded, etc.

CAP does not specify what they mean by validation, so you have to decide what is important to you. The main thing they will want to see is that you have thought through what is required, performed testing according to a plan, and documented results and approvals.

Good luck with your new equipment!

[LESIZE]

Validation for new equipment is mandatory. What do you do if a refrigerator door needs to be replaced due to broken glass? Do you just follow your equipment maintenance protocol? I have an upcoming CAP inspection and I want to document all info any advice.

Thanks

[heathervaught]

LESIZE -- you need to qualify that the repair was successful by testing that parameter (i.e. for replacing a door, you want to verify that it holds temperature for X hours before returning products or reagents), but you don't need to perform a full validation and thest things that obviously weren't impacted by the repair. In our Blood Center, the plan and summary for qualifying the instrument would be approved by our QA department before it was returned to use.