Temperature Mapping

[RR1]

Thank you Malcolm !

Anyway, getting back on track- the requirements for mapping in UK are stated in BS4376 (British Standards parts 1 and 2- for blood fridges and freezers). To maintain validation status and determine position of monitoring and alarm probes, we need to temperature map.

Inspectors are only ensuring we comply to these standards, which have been around for years.

Also remember these are British Standards- so would not apply in the U.S or other countries.

Edited June 23, 2009 by RR1

[heathervaught]

I am in a large blood center in the US. The original question asked if the FDA requirs temperature mapping to be carried out over 20 days...although I did not read every FDA document available, I did look for guidance documents related to Temperature Mapping and found none. I have been at our center for 9 years, and the first time we did any form of temperature mapping was due to an EMEA inspection almost 4 years ago (we ship plasma products to Austria for fractionation). We only map storage units for chambers that store plasma products at any stage of manufacture, test reagents, and supplies used to collect or process the plasma products. We let the probes sit in the storage chamber for at least 48 hours, and try to get a top-middle-bottom reading for each area of storage.

[ABBWalker]

Hi All,

New to the forum, and I can see a lot of conflicting information being banded about, here at ABB we have been in Temperature monitoring for over 125years, and the reports we currently produce for Temperature mapping and Calibration were developed some 40 years ago to NADCAP standards (aviation) which are more stringent than the MHRA, ABB were asked by various hosptiatl's in the UK to do the Mapping and Calibration based from our experience with calibration on our own chart recorders, in the last 18 months we have reaserched this very thorughly and used an ex MHRA inspector to quantify our reports to be the market leaders, if anyone has any sepcific questions or needs help and advice please drop me a quick note, were more than happy to help and offer advice.

Cheers,

David Walker,

david.walker@gb.abb.com

Edited November 2, 2009 by ABBWalker
Spelling errors

[RR1]

Hi David,

Thanks for your info. Could you have a look at the posts in the UK quality section of this forum, and within this is a thread titled 'water or Glycerol monitoring'- your input would be very valuable.

Many thanks!

[ABBWalker]

Hi Rashmi,

A very valid point, as always there is nothing set in stone with the MHRA, but our consultant has advised ordinary "Tap water", so that is what we use, however we have had requests especially from the NBS for 10% Glycerol, which we we did for them.

Cheers,

Dave

[RR1]

I've just had my fridges mapped by an external company. After discussions with the engineer it seems everyone is performing this differently:

1.Some folk are mapping using air probes

2.Some using probes in 200-250mls water/ glycerol

3.Some using probes both in liquid and out of liquid for each position.

4.We did our mapping using air temps, with one 200ml core mapping probe and one 50ml core mapping probe beside the monitoring probe (just as a test).

I thought the purpose of mapping (and especially using a minimum 5min data collection time_) was to enable fluctuations to be seen easily in different areas of the fridge. Surely if the mapping probes are sited in liquid, you will certainly not see these fluctuations in a 5 min timespan.

The purpose of mapping is not just to show us that the core temperature of blood units can be maintained within our fridges between 2'C to 6'C, but also to show that certain areas within the fridge may have hot/cold spots where it would not be a good idea to store small components/ products.

Also as equipment deteriorates these areas may become more pronounced- so is a good indication of overall fridge performance.

Thought on this please- thanks!

[Steven Jeff]

I entirely agree with you Rashmi, there are many people who do not seem to understand temperature mapping and control, including some engineers.

Temperature mapping must be carried out using air temperature probes to reflect quick changes in temperature in the hot and cold spots of the blood bank. Probes immersed in fluid do not change quick enough.

Steve

:)

[RR1]

Thanks Steve. There was an excellent presentation given by the MHRA during the 2009 roadshows that included quite a bit on temperature mapping, I had asked them if I could add to the library area of the forum, but so far no response....i'll get around to asking again sometime.

[ABBWalker]

Hi Rashmi,

This subject is open to different interputations throughout the UK, we believe in giving the customers what they want, to give them peace of mind.

However you know who we go too, for advice from time to time, and I will send you said info privately, you should map in core with 200ml of ordinary "tapwater", some add Glycerol such as the NBS, which is optional, the reason for water and not air, is the temperature fluctuations are more accurate, and when you have an intrusion (door opening) the data is then recorded in seconds, so you can see the temperature rising the longer you leave the door open, we have also found when air temps have been used in some fridges that are borderline, you can have shelves taken out of service for cold or hot spots, using water can sometimes bring them back into use.

Cheers

ABBWalker.

[RR1]

Thanks ABBWalker, as you say this is very much open to interpretation, and as we discussed earlier (privately), I do have concerns about the 200-250ml volumes used for core readings.

Whatever validations/ testing is being performed should always be based on looking at the 'worst case' scenario, in this case if paediatric blood units are being stored, then the core readings should be performed in 50ml liquid. If a paediatric pack is constantly exposed to air temps above 6'C, then it is possible that the actual component itself will reflect this temperature and not the required one core one. How do we know to what level of harm this may cause a neonate?

If small vial products such as anti-D Ig is being stored (?3ml vol), how long would the internal core temperature of this volume remain at 2-8'C (which is different to red cells in uk= 2-6'C), if the air temp of the unit fluctuates regularly.

Does air temperature of a cabinet= the core temperature of small volume products?.....this is something that may need to be addressed by the mapping.

I am very surprised that pharmaceuticals/ hospital pharmacy dept etc have not addressed this. Some medications can be severly affected by temperature variations such that they may not be of optimum benefit to a patient if stored incorrectly........about time hospitals mapped all their medicines fridges????

[ABBWalker]

Thanks Rashmi, we could casue a real debate on this subject, on the issue of pharmacies, I understand there are moves to bring them in alignment with the Bloodbanks, as the commercial pharma companies already come under MHRA scrutiny, I now a quite a few hospital pharmacy sites have been included at the same time as we do the Bloodbanks and some have also approached us separately.

I was led to believe something offical was coming out later this year not sure when so until its confirmed.

Cheers

ABBwalker.

[Ellen Zeigler]

In my former life with a large blood supplier, we were required to map our refrigerators. The brain is a bit rusty after 7-8 years but it was not 20 days. It was a continuous process that if memory serves logged temps every 10 minutes for at least 24 (maybe 48 )hours. If we had walk-in coolers with dual compressors we were mapping each compressor (and they really are different). The temperature mapping equipement had multiple probes and the storage equipment had to have a certain level of materials (sometimes we refrigerated carboys of saline to get the volume up) becasue refrigerators/freezers that are "full" operate more consistently.

The four hours may have grown out of the AABB 5.1.8.2 "For storage of blood products. the temperatures hall be continuously mmonitored or the temperature shall be recorded at least every 4 hours."

Hope this helps.

[ar_confederate]

I have a question for ya'll about mapping. It's not been a requirement here in the US but as a blood center, we've decided to start temperature mapping when we validate or revalidate storage units.

What is the purpose of the temp mapping? Is it to show air temps or the internal temps of the components? From a novice's viewpoint, it seems that the air temps would be too easliy affected by transient events, such as opening a door or defrost cycles, to really give a good idea of areas that are unsafe for the components. If we are looking for internal component temps, could you not put your probes or thermometers into a liquid solution that simulates your smallest component volume?

Thanks!

Emmett

[Ellen Zeigler]

I have a question for ya'll about mapping. It's not been a requirement here in the US but as a blood center, we've decided to start temperature mapping when we validate or revalidate storage units.

What is the purpose of the temp mapping? Is it to show air temps or the internal temps of the components? From a novice's viewpoint, it seems that the air temps would be too easliy affected by transient events, such as opening a door or defrost cycles, to really give a good idea of areas that are unsafe for the components. If we are looking for internal component temps, could you not put your probes or thermometers into a liquid solution that simulates your smallest component volume?

Thanks!

Emmett

To back up - the refrigerator needs to be "off limits" during the mapping process. The intent is to get an idea of what the normal (without stress) limits and cycles are for the compressors and fans. Do you have hot spots, or cold spots? It gives you the background that you can then [potentially] make more educated guesses on excursions out of range, i.e., normal for the refrigerator, or not.

[RR1]

I have a question for ya'll about mapping. It's not been a requirement here in the US but as a blood center, we've decided to start temperature mapping when we validate or revalidate storage units.

What is the purpose of the temp mapping? Is it to show air temps or the internal temps of the components? From a novice's viewpoint, it seems that the air temps would be too easliy affected by transient events, such as opening a door or defrost cycles, to really give a good idea of areas that are unsafe for the components. If we are looking for internal component temps, could you not put your probes or thermometers into a liquid solution that simulates your smallest component volume?

Thanks!

Emmett

Hi Emmett,

I think the purpose of mapping is

• To show temperature stability of the equipment.
  
• Highlight any hot/ cold spots that it may not be a good idea to store some components
  
• Show equipment performance.
  
• To show that your chart temperatures/ digital readouts are reflecting the temperatures in the cabinet- ie that the probes for these are located in the correct positions.
  

Somewhere along the line there needs to be a comparison using mapping probes in water or whatever, to show how the internal cabinet 'air' temperatures (especially in the hot/ cold spots) are affecting the 'core' temperature of the simulated component. The volume used for this test should be based on possibly maximum and minimum size of components/ products stored in the fridge (worst case scenarios).

In the UK we map with components in -situ - for annual or after servicing mapping. For new equipment these are mapped empty and then Full prior to routine use.

Edited February 2, 2010 by RR1

[Tadpole]

I am completely amazed that American hospitals are not mapping or even required to. While not explcity stated in regulations, the FDA has been tightening the screws on American Blood Collection organizaitons to map not only storage units but work areas, incubators, shipping boxes, etc. since approximately 1997 and citing if it is not done, or not done appropriately. Basically, if pharma does it, the expectation is that blood manufacturing facilities will as well as blood is classed both as a drug and a biologic.

Basically the blood collection organizations are held, IMO, to much higher standards overall than the hospitals.

It is definitely value added for reasons previously stated. The timeframes are variable but mapping is typically done full and empty chamber as airflow can be influenced by loads and then must be redone based on a change assessment after changes are made to the system.

[RR1]

Thanks Rashmi, we could casue a real debate on this subject, on the issue of pharmacies, I understand there are moves to bring them in alignment with the Bloodbanks, as the commercial pharma companies already come under MHRA scrutiny, I now a quite a few hospital pharmacy sites have been included at the same time as we do the Bloodbanks and some have also approached us separately.

I was led to believe something offical was coming out later this year not sure when so until its confirmed.

Cheers

ABBwalker.

Hi ABBwalker,

I know many Pharmacy depts map their fridges within their actual location, but do they map every medicine fridge within the hospital ? Nearly every ward has one of these.