Cooling Equipment Qualification for Medical Device Manufacturing

H

htquality

#1
Hello,
We are a Medical Device company and are ISO 13485 certified and also comply with 21 CFR par 820. We perform annual qualification (complete mappimg studies) of our storage chambers (i.e. cold room/refrigrator) on an annual basis but one of our suppliers doesn't. They mapped the chamber once back in 2005, and only perform annual calibration. Is that a sufficient approach or if they they should be performing a complete mapping study on a more frequent basis to ensure that the chamber continues to perform properly?
Thanks!
 
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ScottK

Not out of the crisis
Staff member
Super Moderator
#2
Re: Equipment Qualification

Can you give more information?
-What is the cold storage chamber for?
-What is your supplier supplying that you feel their controls may be inadequate?
-Have you been using this supplier for a long time? If so have there been any quality or regulatory problems related to this issue?
-How do you come about with your monitoting scheme?
-Do you find many deviations in your annual scheme?

it really comes down to what is being stored in the chamber and how critical it is to be within the required temperature range.... and how tight the temperature range tolerance.

you can always ask them to provide you with a temperature profile if they want to keep your business.

Either way it seems an annual mapping study with a calibrated controller won't catch seasonal variation. I've always used data loggers with alarms to monitor year round.
 
H

htquality

#3
Re: Equipment Qualification

Thank you for your feedback Scott. The chamber is used to store product that needs to be kept at 2-8 °C. We/they also use a continuous monitoring system (chart recorder), but this only monitors the temperature in one point in the chamber. Our annual mapping studies use several probes to ensure that the temperature distribution is uniform throughout the unit (top, bottom, front, back, and everywhere in between).
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#4
Re: Equipment Qualification

Thank you for your feedback Scott. The chamber is used to store product that needs to be kept at 2-8 °C. We/they also use a continuous monitoring system (chart recorder), but this only monitors the temperature in one point in the chamber. Our annual mapping studies use several probes to ensure that the temperature distribution is uniform throughout the unit (top, bottom, front, back, and everywhere in between).
how big is the enclosure?
 
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