Calibration/Verification of thermo-hygrometer in storage areas

A

Aliasanonymous

#1
Hi Covers,

Just to seek some opinions on the following issue:
I have a medical device storage area and storage requirements for the MDs involved are in the range of 0-40degC, 10-85% RH.
The issue here is that monitoring of the conditions are necessary, but at the same time the risk of this going out of spec is really low.
I have a thermo-hygrometer that's supplied with a calibration certificate. However, I see no value in subsequent calibration due to the wide specification range (or am I wrong in this). Day to day readings are at about 25degC and 55%RH. So, I am thinking I would do verification of the readings, say every 2 years, instead of calibration. Would that be ok or even necessary?

Also, I read that verification of temperature is usually done at ice point and boiling point. But the thermo-hygrometer only has a range of 0-50degC. How else should I go about doing a verification.
Can I also use the salt test as a humidity reading verification?

P/S: I would like to avoid unnecessary cost of calibration, or having to throw out a working thermo-hygrometer every so often.

Thanks in advance!
 
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BradM

Staff member
Admin
#2
Those specs are large enough to drive a truck through. :D

Question... Is it even physically possible for the storage area to ever be out of spec?

My short answer is I would have your device calibrated every 2 years or so by a competent vendor. In the end, it will be your least expensive option.
 
A

Aliasanonymous

#3
Physically, no. But is it sufficient as a justification to not monitor the conditions? It is after all a storage requirement on the label and all.

Also, you're saying if I were to monitor the conditions, I have to calibrate. Just a matter of frequency?
 
A

Aliasanonymous

#4
Another issue,

Would it be justified to stop monitoring storage conditions when the store is empty and is foreseen to be empty for a long while more?
I mean, it is empty, so what is it I am preserving. Right?
 

BradM

Staff member
Admin
#5
Physically, no. But is it sufficient as a justification to not monitor the conditions? It is after all a storage requirement on the label and all.
If you could provide sufficient documentation/risk analysis, then no you would not have to monitor. However, I think the easier path would be to monitor with a calibrated device.

Also, you're saying if I were to monitor the conditions, I have to calibrate. Just a matter of frequency?
Yes, if you monitor you need to be able to assure the values are accurate. If it was me, I would have the device calibrated first every six months. If it passed three times, extend to a year, and so on.

You may want to keep a log and make sure you verify (and document) the temperature/RH on a routine basis.
 

BradM

Staff member
Admin
#6
Another issue,

Would it be justified to stop monitoring storage conditions when the store is empty and is foreseen to be empty for a long while more?
I mean, it is empty, so what is it I am preserving. Right?
If there is no product (rationale for verifying the environmental conditions of the area), then there would be no reason to verify. You would just want to have sufficient evidence that the area was in specification while product was there. Also, you will want to assure the area is tagged/labeled appropriately so others know the area is not "controlled".
 

somashekar

Staff member
Admin
#7
Hi Covers,

Just to seek some opinions on the following issue:
I have a medical device storage area and storage requirements for the MDs involved are in the range of 0-40degC, 10-85% RH.
The issue here is that monitoring of the conditions are necessary, but at the same time the risk of this going out of spec is really low.
I have a thermo-hygrometer that's supplied with a calibration certificate. However, I see no value in subsequent calibration due to the wide specification range (or am I wrong in this). Day to day readings are at about 25degC and 55%RH. So, I am thinking I would do verification of the readings, say every 2 years, instead of calibration. Would that be ok or even necessary?

Also, I read that verification of temperature is usually done at ice point and boiling point. But the thermo-hygrometer only has a range of 0-50degC. How else should I go about doing a verification.
Can I also use the salt test as a humidity reading verification?

P/S: I would like to avoid unnecessary cost of calibration, or having to throw out a working thermo-hygrometer every so often.

Thanks in advance!
If I were you in your place, depending upon the room size, I would run one or two or more ceiling fans and hang one or two good make thermohygrometer, and note down the values few times during peak day. I would compare the same with my local area weather report which can be accessed to check if my readings correlate. I would just go on and maintain the situation, and then compare the year trend from weather reports to my records.
 

Hershal

Metrologist-Auditor
Trusted Information Resource
#8
I agree with Bradm, the device should be calibrated. I would have it calibrated at the upper and lower end of your storage room requirement and a point in the middle. Both Temp and RH need to have that approach. You should use an accredited lab with temp and RH in the scope, and make sure to get the uncertainty so you know how much error you have.

I would go with annual till you have sufficient evidence to justify extending the cycle.

Remember, this is not just expense, it is managing and avoiding unnecessary risk to the organization.

Hope this helps.
 
A

Aliasanonymous

#9
Thank you all for the replies, much appreciated.

I understand the need to ensure that the readings are accurate. But I'm not so sure about sending it for calibration yearly, given that the cost of the thermo hygrometer is less than that of the calibration..

But I gather that there is no hard and fast rule to this, as long as there is reasonable justification. I'll work things out based on risk and the trend of the readings as time goes by. And hopefully convince the NB to accept those arrangements.

Thank you once again! The forum never fail to provide valuable insights! :agree1::thanks:
 
W

WalkingSeed

#10
Bradm and Herschel have it right.

If you have products destined for sale in the United States or are a US manufacturing location I recommend that you take a look at 21-CFR-820 and pay particular attention to 820.72. What you are proposing may be a violation of the law and net you a 483.

Is saving $150.00 to $300.00 a year really worth the risk?
 
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