IQ and OQ for a "Dormitory" Refrigerator - Temperature Stability

[Candi1024]

We are writing an IQOQ for a standard little college dormitory style refrigerator. We store various materials in this refrigerator that need to be either simply "cool" or approximately 5-10 degrees C.

We seem to be going back and forth on how to verify the temperature is adequate. The main point of contention is wording.

Verify that the temperature is stable at 45degrees +- 5 degrees.

What does stable mean? How long does it need to be stable for? Each time we open the refrigerator to check the temperature, it will be less stable. There are no temperature readings built into this refrigerator, it is set with a dial ranging from 1 to 7.

I'm thinking we should be verifying on a regular basis that the temperature is still adequate. ...

 

[Ninja]

Re: IQOQ on "Dormitory" refrigerator

If all you need is "cool" or "approximately", why not check it each monday morning>

Is there significant damage caused if it is not "cool" or riding at 15C for the weekend?

 

[hogheavenfarm]

Re: IQOQ on "Dormitory" refrigerator

A simple indoor - outdoor thermometer (with the sensor on a thin wire) could be hooked up on the outside with the wire run inside. Just monitor the temperature from the outside. Should it (the indoor -outdoor thermometer) need to be 'calibrated' just use a lab thermometer against it for 'calibration'. This type of setup could even be automatically recording if hooked to a digital-analog converter, this will feed through a spreadsheet into excel, we did this with our mixing room back in 2000 and it worked very well.

 

[Ajit Basrur]

Re: IQOQ for a "Dormitory" refrigerator - Temperature stability

We are writing an IQOQ for a standard little college dormitory style refrigerator. We store various materials in this refrigerator that need to be either simply "cool" or approximately 5-10 degrees C.

We seem to be going back and forth on how to verify the temperature is adequate. The main point of contention is wording.

Verify that the temperature is stable at 45degrees +- 5 degrees.

What does stable mean? How long does it need to be stable for? Each time we open the refrigerator to check the temperature, it will be less stable. There are no temperature readings built into this refrigerator, it is set with a dial ranging from 1 to 7.

I'm thinking we should be verifying on a regular basis that the temperature is still adequate. ...

You are mixing two terms - "Cold", and "Cool"

Cold :
Any temperature not exceeding 8° (46°F) is “cold.” A “refrigerator” is a cold place in which the temperature is maintained thermostatically between 2° and 8° (36° and 46°F).

Cool:
Any temperature between 8° and 15° (46° and 59°F) is “cool.”

 

[v9991]

Re: IQOQ for a "Dormitory" refrigerator - Temperature stability

Verify that the temperature is stable at 45degrees +- 5 degrees.
What does stable mean? How long does it need to be stable for? Each time we open the refrigerator to check the temperature, it will be less stable. There are no temperature readings built into this refrigerator, it is set with a dial ranging from 1 to 7.

from cGMPs point of view, the 'criticality' of its relevance would determine the extent&depth of controls required. ( with each of the qualification - calibration/performance-verification, routine monitoring etc)
viz., Dormitory refrigerator, used for storing chemicals - standards - materials ., etc

in essence, I would not like to stop at saying, "'risk based approach'.... based on the impact on cGMPs, etc., " but emphasize the -pre-definition of the approach, and then 'reference of data' based on which the relevant decision is arrived & documented.
Following references could provide certain inputs..., in assessing the relevance and requirements.

Elements to Consider When Qualifying Control Environmental Chambers Used for CGMP Applications


Qualification of temperature-controlled storage areas


temperature mapping protocol...


http://lib3.dss.go.th/fulltext/Journal/analyst/Analyst1998/no.9/1988v123n9p1879-1886.pdf

here's quick ref. to definitions of storage conditions.. USP34-NF29 General Notices.pdf

10.30.20. Cold
Any temperature not exceeding 8° (46°F) is “cold.” A “refrigerator” is a cold place in which the temperature is maintained thermostatically between 2° and 8° (36° and 46°F).

10.30.30. Cool
Any temperature between 8 ° and 15° (46° and 59°F) is“cool.” An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by the individual monograph.