This message was posted by a user wishing to remain anonymous

​RAPS Community,

I would like to have some feedback from some equipment experts or consultants with equipment experience.  In qualifying/validating a new piece of temperature controlled equipment (incubator, refrigerator, freezer), what is the standard for temperature mapping?  6, 8, 12, 24 hours of temperature mapping? 

Secondly, is there a particular guidance/regulation (i.e. ISO 13485, CFR1271, CFR210/211) that states such requirements?  Currently we do 12 locations (probes) with one minute intervals for readings, for 24 hours.  I find that to be somewhat excessive given the number of data points achieved to show a steady profile once equilibrium is reached.  I do not have a history as to where the current 24 hour requirement came from but would like to have some input.  Could one perform a 12 hour calibration once equilibrium is reached?

Thanks in advance for your responses.

Dear Anon,

There are no specific requirements of a regulation (i.e. ISO 13485 or CFR) on how to perform the temperature mapping. You can find only general requirements for the control and monitoring of storage equipment.

In most of the cases there are some standards such as DKD-R 5-7 or EN 60068-3-5:2018, as well as others for specific types of temperature controlled equipment, such as EN 285:2015 for sterilizers.

The number of probes or data loggers used in the temperature mapping, as well as the intervals and the total calibration time vary according to the type of equipment / area you want to study. Usually, if you perform a temperature mapping in a large storage area, 12 hours are not enough, because you do not cover the entire variation of the external climate conditions. Another issue is the time of the year that you perform this study.
In small equipment, such as freezers or incubators, less time than 12 hours is usually required.
Of course if you regularly monitor the temperature controlled equipment with a data logger, you should evaluate the temperature mapping in order to place the appropriate number of data loggers in the worst-case conditions of temperature and/or humidity.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 10-Dec-2019 15:34
From: Anonymous Member
Subject: Temperature Mapping

This message was posted by a user wishing to remain anonymous

​RAPS Community,

I would like to have some feedback from some equipment experts or consultants with equipment experience.  In qualifying/validating a new piece of temperature controlled equipment (incubator, refrigerator, freezer), what is the standard for temperature mapping?  6, 8, 12, 24 hours of temperature mapping?

Secondly, is there a particular guidance/regulation (i.e. ISO 13485, CFR1271, CFR210/211) that states such requirements?  Currently we do 12 locations (probes) with one minute intervals for readings, for 24 hours.  I find that to be somewhat excessive given the number of data points achieved to show a steady profile once equilibrium is reached.  I do not have a history as to where the current 24 hour requirement came from but would like to have some input.  Could one perform a 12 hour calibration once equilibrium is reached?

Thanks in advance for your responses.

Hello Anon,

Spyros is correct there is no governing regulation for what is required on temperature mapping, but there are some standards and guidance documents out there.  If you search through this forum, there was a similar question asked about a year ago where there was some additional information provided.  Temperature mapping is usually specified in standards associated with sterilisers or storage containers for blood products.  There are a few white papers or guides out there published by different groups like ISPE Cold Chain Management as there are many GDP requirements for distributors for maintaining products at specific temperatures.  The time really depends on the storage conditions or anticipated storage conditions, so if long term as long as you show stability then maybe 12 hours is fine, I usually did my studies for 24 hours to encompass a "full work day" on what would be expected.  If there is too much data, then just take a point every 20 second or 30 seconds instead of 1 second intervals.  It depends on what is being stored, how it is being accessed, and product requirements.  Make sure you conduct other aspects like open door challenges, and fault conditions.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 11-Dec-2019 03:28
From: Spyros Drivelos
Subject: Temperature Mapping

Dear Anon,

There are no specific requirements of a regulation (i.e. ISO 13485 or CFR) on how to perform the temperature mapping. You can find only general requirements for the control and monitoring of storage equipment.

In most of the cases there are some standards such as DKD-R 5-7 or EN 60068-3-5:2018, as well as others for specific types of temperature controlled equipment, such as EN 285:2015 for sterilizers.

The number of probes or data loggers used in the temperature mapping, as well as the intervals and the total calibration time vary according to the type of equipment / area you want to study. Usually, if you perform a temperature mapping in a large storage area, 12 hours are not enough, because you do not cover the entire variation of the external climate conditions. Another issue is the time of the year that you perform this study.
In small equipment, such as freezers or incubators, less time than 12 hours is usually required.
Of course if you regularly monitor the temperature controlled equipment with a data logger, you should evaluate the temperature mapping in order to place the appropriate number of data loggers in the worst-case conditions of temperature and/or humidity.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 10-Dec-2019 15:34
From: Anonymous Member
Subject: Temperature Mapping

This message was posted by a user wishing to remain anonymous

​RAPS Community,

I would like to have some feedback from some equipment experts or consultants with equipment experience.  In qualifying/validating a new piece of temperature controlled equipment (incubator, refrigerator, freezer), what is the standard for temperature mapping?  6, 8, 12, 24 hours of temperature mapping?

Secondly, is there a particular guidance/regulation (i.e. ISO 13485, CFR1271, CFR210/211) that states such requirements?  Currently we do 12 locations (probes) with one minute intervals for readings, for 24 hours.  I find that to be somewhat excessive given the number of data points achieved to show a steady profile once equilibrium is reached.  I do not have a history as to where the current 24 hour requirement came from but would like to have some input.  Could one perform a 12 hour calibration once equilibrium is reached?

Thanks in advance for your responses.

This message was posted by a user wishing to remain anonymous

Check out this Standard: EN 12830:2018

Original Message:
Sent: 10-Dec-2019 15:34
From: Anonymous Member
Subject: Temperature Mapping

This message was posted by a user wishing to remain anonymous

​RAPS Community,

I would like to have some feedback from some equipment experts or consultants with equipment experience.  In qualifying/validating a new piece of temperature controlled equipment (incubator, refrigerator, freezer), what is the standard for temperature mapping?  6, 8, 12, 24 hours of temperature mapping?

Secondly, is there a particular guidance/regulation (i.e. ISO 13485, CFR1271, CFR210/211) that states such requirements?  Currently we do 12 locations (probes) with one minute intervals for readings, for 24 hours.  I find that to be somewhat excessive given the number of data points achieved to show a steady profile once equilibrium is reached.  I do not have a history as to where the current 24 hour requirement came from but would like to have some input.  Could one perform a 12 hour calibration once equilibrium is reached?

Thanks in advance for your responses.

This message was posted by a user wishing to remain anonymous

​Hi Anon,

My suggestions are based on keeping auditors/inspectors happy, not necessarily what I think is absolutely required. But keeping auditors/inspectors happy is part of the job. Another caveat is that in most of my experience, there are rooms set aside to freezer/refrigerator storage with dedicated HVAC systems to pump the heat generated to outside the building. And HVAC performance and settings can influence temperature-controlled equipment. Your situation may differ.

With those two thoughts in mind, the minimum time you should temperature map is 24 hours because that takes in a complete workday and a complete HVAC settings cycle. A better mapping cycle is for 7 days. (You definitely don't need a data point every second.) That allows for the norm in business buildings that have different HVAC settings on the weekend than during the weekdays to conserve energy. You can alleviate that by making all 7 days the same for your HVAC, but you would be surprised how many businesses don't. And it does make a difference in freezer performance. Not that they are out of specification, but I have seen Mon-Fri temp traces that look like sine waves and Sat-Sun look like a seismograph during an earthquake. Root cause traced to the temperature the room could reach on the weekend versus weekdays. Warm room equals more freezer cycling.

If you are just setting up to do the temperature mapping, another suggestion is to make sure the "worst case" location from your 12 probes in each unit is identified. You will be expected to place the unit probe for routine monitoring in that location. Citing this as a deficiency seems to be a current fad with auditors.

Cheers,
Kevin

Original Message:
Sent: 10-Dec-2019 15:34
From: Anonymous Member
Subject: Temperature Mapping

This message was posted by a user wishing to remain anonymous

​RAPS Community,

I would like to have some feedback from some equipment experts or consultants with equipment experience.  In qualifying/validating a new piece of temperature controlled equipment (incubator, refrigerator, freezer), what is the standard for temperature mapping?  6, 8, 12, 24 hours of temperature mapping?

Secondly, is there a particular guidance/regulation (i.e. ISO 13485, CFR1271, CFR210/211) that states such requirements?  Currently we do 12 locations (probes) with one minute intervals for readings, for 24 hours.  I find that to be somewhat excessive given the number of data points achieved to show a steady profile once equilibrium is reached.  I do not have a history as to where the current 24 hour requirement came from but would like to have some input.  Could one perform a 12 hour calibration once equilibrium is reached?

Thanks in advance for your responses.

This message was posted by a user wishing to remain anonymous

As a guidance, you can also check out the WHO document (link below). Note that this is specific to storage of pharmaceutical products

• https://www.who.int/medicines/areas/quality_safety/quality_assurance/TS-mapping-storage-areas-final-sign-off-a.pdf
• Another document that you may find helpful is: https://www.vaisala.com/sites/default/files/documents/LSH-8-Steps-to-Mapping-Validation-Project.pdf

All the best
N
Original Message:
Sent: 10-Dec-2019 15:34
From: Anonymous Member
Subject: Temperature Mapping

This message was posted by a user wishing to remain anonymous

​RAPS Community,

I would like to have some feedback from some equipment experts or consultants with equipment experience.  In qualifying/validating a new piece of temperature controlled equipment (incubator, refrigerator, freezer), what is the standard for temperature mapping?  6, 8, 12, 24 hours of temperature mapping?

Secondly, is there a particular guidance/regulation (i.e. ISO 13485, CFR1271, CFR210/211) that states such requirements?  Currently we do 12 locations (probes) with one minute intervals for readings, for 24 hours.  I find that to be somewhat excessive given the number of data points achieved to show a steady profile once equilibrium is reached.  I do not have a history as to where the current 24 hour requirement came from but would like to have some input.  Could one perform a 12 hour calibration once equilibrium is reached?

Thanks in advance for your responses.