Laboratory Refrigerator Validation and Chamber Temperature Distribution

[Seeisoguy - 2011]

Alex,
Where does one find information on the web about cGxP compliance?
I found plenty of information on consulting services but is there a regulatory govermental body?

 

[BradM]

There is now legislation in nearly all countries to ensure that all regulatory controlled drugs are protected from the effects of out of specification temperature storage, since it is now accepted that there are known cases where the efficacy of drugs has been directly impaired because they were not store at the specified temperature. In fact nearly one thousand instances in one relatively small health authority. It is now mandatory to ensure your fridges and freezer are cGxP compliant.

For cGxP compliance all refrigerators and freezers used in the cold chain must be brought in to line with the current legislation and should already be fitted with;-

1. An external indication of internal temperature.
2. A door not closed alarm.
3. A power cord electric power on or off alarm.
4. A temperature out of specification alarm.
5. A Controlled entry system.
6. A temperature data logger.
7. A validation of internal temperature spread.

Alex Kennedy

Alex, thank you. I'm certainly not disputing your claims. But I would be interested in a link or reference to a source for this. It would be very interesting.

 

[KellyLS]

Re: Laboratory Refrigerator Validation

Based on the AHAM HRF-1-2008 standard. It gives instructions on how and where to place thermocouple for the various types of refrigeration products based on volume. It also gives information of length of the test. Ambient temperation and test conditions to consider.
The AHAM HRF-1-2008 standard should guide you on your testing.

That standard is for "household" units. I would expect a laboratory grade fridge to perform much better and as such, should hold tighter than that standard.

 

[Patzer]

I have been involved in the quaification of a good number of fridges and freezers in 2011 for a medical device manufacturer.

There are some standard tests that need to be covered, many of which have been mention earlier.

Door open alarms, door open recovery tests, power failure, recovery tests, how the unit responds to a power failure event i.e. are the settings maintained. Alarms (high and low)

In terms of mapping, the internal volume of the unit will determine the number of points that need to be logged. Typically 9 points!!!

I tend to do the empty map as part of the OQ and the full map as part of the PQ.

I have included two attachments that I have found very useful.
One is from the Irish National Metrology lab, the other is a white paper from a US temperature logging vendor (which I have no affiliation with).

Hope this is of some use.

Here is the link to the previously attached document: CEN-LSH-8 Steps to Executing the Perfect Thermal Validation Project-B211103EN-A Low.pdf

Pat

 

[Marc]

I have replaced the document with a link to it. It's essentially a brochure for use of a product and as such an advertisement, but does contain standard information about "mapping" a thermal chamber. I did that stuff back in the 1980's and nothing has changed other than that we used thermocouples and real time data collection rather than self contained units like the one in the brochure.

 

[alex.Kennedy]

Hi again

Your request for reference sources for all the modifications that are required to be incorporated into mobile and or static freezer/temperature cabinets to ensure the cabinet contents conditions are maintained as per the process specified conditions, is a miss-directed request. The majority of these requirements are basic essentials that are necessary to enable you to produce document evidence regarding product storage temperatures through the period of their storage.



It is a regulatory requirement that the stored products are never subjected to temperatures outside the process specified limits. It is therefore required during product process development of these refrigerated cabinets, that internal storage conditions are researched and maximum safe (for product) times for the doors being open and or the cabinet being isolated from the main power supply are established. Obviously it is essential that alarms (loud) prevent this period ever being exceeded. All these design features are required to be validated during the cabinet qualification processes.



Recently during development of 150 mobile 4 cubic metre cabinets it was established that by far the most effective way of preventing these incidents occurring, was by fitting ‘power removed’ alarms. I.e with the cabinet in the RUN configuration removal of external mains power (by any means) triggers a powerful audible alarm. This single safety system proved to be a highly cost effective addition.


So to return to the first statement; the regulators usually use soft statements that force you to research the requirements. This forces you to develop your equipment in such a way that all your process parameters are verifiable and validatable.



Sample;
21 CFR Part 211.44 Lighting. Adequate lighting shall be provided in all areas.
This simple requirement is compounded where multiple work / inspection areas are involved. The design engineer must research national and at times international lighting requirements; for a multitude of reasons, i.e – safety/health/inspection/colour perception. The regulators will also expect to be able to review a documented justification for the level of lighting chosen; for each area. Then they expect to see verification that this level has actually been attained in all areas where visual perception could impact on product quality, efficacy and or records.

Regards
Alex

 

[kaismith]

For this you can use simple calibrated thermometer.

 

[farakiko1]

Haay

I have a new fridge in my lab with temp range till -30 degree celcius
can i run this fridge always on -30 or i have to get another fridge with lower range such - 50 or - 80 to run it on -30??????????????????