Can you Validate a Refrigerator Truck like a Walk-in? Four Key Differences in These Storage Areas

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Janice Bennett-Livingston
Jan 19th 2018
Industrial Measurements
Life Science
In this week's blog we answer a question about validating cold-storage for pharmaceutical and biotechnology... are there differences?

  
Hello Paul,
I have just reviewed your webinar “Environmental Mapping - Temperature Mapping Protocols.” There was one slide that talked about “recording ambient conditions,” which made me think about an issue we have…
 
We are implementing a reefer truck (located outdoors by the loading dock) to handle storage of overflow finished goods. We plan to validate the reefer truck in the same way as we would a walk-in cooler (temperature specification 2 – 8°C and located indoors).
 
First, there is a potential long-run problem  because we are located in very cold climate (Eastern Canada). Secondly, how would recording ambient conditions work in the validation of the reefer truck? Would seasonal temperature mapping be something you'd recommend in this case? Thank you very much for your advice!
 
W
 

Paul Daniel:

 
Thank you for contacting us W!
 
You have highlighted some of the important differences between walk-in coolers and reefer trucks.
 
  1. It is outside.
  2. All 4 walls are exposed to the ambient conditions.
  3. Reefer trucks are typically not as well insulated as a cold room.
  4. Reefer trucks are not optimized for air-flow patterns like a cold room, because they are restrained by the trailer shape, and the location of the cooling system at the head of the trailer.
 
You will probably have a problem in winter, as reefer trucks (at least here in the more temperate climate of California) do not have heating capability.  If your reefer truck has some heating capability, you may do fine in winter.  I do not know what is typical for an Eastern Canadian reefer truck.
 
Normally, for a cold room, I wouldn’t worry about ambient conditions.  That is because the assumption is that the cold room is operating inside a controlled ambient space, such as a warehouse.  However, in this case, your reefer truck cold room is outside in an uncontrolled space.  Therefore, I would apply some of the same principles as I would to a warehouse, which typically has walls that are also the exterior of the building, and are therefore impacted more strongly by seasonal variations. 
 
In your case, I would recommend seasonal mapping.  To record ambient conditions in this case, I would simply place a mapping sensor adjacent to the reefer truck, in the shade, in an area where it won’t be affected by the heat output from the reefer compressor.  This will allow you to: 1) prove that you mapped at a representative hottest/coldest time of year, and 2) you can correlate internal temperature variations to what is going on outside.
 
It occurs to me that it would be very much in your best interests to have the reefer truck in as sheltered an environment as possible – in the shade and out of the wind. Do be prepared to discover that your reefer cold room is too cold in the winter for refrigerated storage. 
I hope this is helpful.  Please feel free to ask any follow-up questions!
 
We have another blog that gives further guidance:
Best Regards,
Paul Daniel
 

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Contributors

Paul Daniel

Paul Daniel

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.

Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.

Janice Bennett-Livingston

Marketing Manager

In addition to editing the Vaisala Life Science blog, Janice Bennett-Livingston is the Global Life Science Marketing Manager for Vaisala's Industrial Measurements business area.

Pre-Vaisala writing credits include a monthly column called "Research Watch" for Canada's award-winning magazine alive, as well as articles in Canadian Living and other periodicals. Other past work: copywriting for DDB Canada, technical writing at Business Objects, and communications specialist for the British Columbia Child & Family Research Institute.

Comment

Eleanor Sharp

Jul 25th 2018
Please keep the info coming, very helpful.
E

Janice Bennett-Livingston

Jul 25th 2018
Thank you very much! This feedback helps us focus on providing great blogs! :D

Paul Harber

Jul 25th 2018
Adding to your point 4 above. It is critical to place any product at least 4 inches from the trailer sidewalls because of the limited capability of the air flow system in a reefer.

Janice Bennett-Livingston

Jul 25th 2018
Thank you very much for highlighting the airflow issue in containers !

Arless Dowling

Jul 25th 2018
Please continue with emails and webinar that are available.
Best regards

Janice Bennett-Livingston

Jul 25th 2018
Dear Arless,

Thank you very much for reading our blog!

To ensure that we can email you, it is best if you subscribe to one of our eNewsletters. With you permission, we may then send you emails regularly!

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Many thanks!

Henry Comartin

Jul 25th 2018
Can I have access of previous discussions on validating walk-in Freezers and Refrigerators?

Janice Bennett-Livingston

Jul 25th 2018
Dear sir,

Thank you for reading our blog!
Please find other articles on validation/qualification of cold environments here:

https://www.vaisala.com/en/blog/2017-11/whats-your-open-door-mapping-study-policy

https://www.vaisala.com/en/blog/2017-11/trusting-fans-temperature-uniformity-vs-loading-styles-mapping-studies

https://www.vaisala.com/en/blog/2017-11/three-questions-you-need-answer-monitoring-controlled-temperature-chambers

https://www.vaisala.com/en/blog/2017-12/5-ways-treat-misbehaving-refrigerator

https://www.vaisala.com/en/blog/2018-01/why-not-use-mean-kinetic-temperature-cold-applications-heres-

https://www.vaisala.com/en/blog/2017-11/trusting-fans-temperature-uniformity-vs-loading-styles-mapping-studies

Also, we have an extensive white paper on validation:
https://www.vaisala.com/sites/default/files/documents/CEN-LSC-AMER-5-Rules-of-Sensor-Placement-B211369EN-A.pdf

And here is an eBook on Validation/Mapping applications:

https://www.vaisala.com/sites/default/files/documents/CEN-LSC-G-eBook-Troubleshooting-Tips-for-Validation-Mapping-Applications-2013-B211345EN-A_Low.pdf

Thanks again!

Bob Maschin

Jul 25th 2018
Thanks for this continuing education base. Helps to validate the way been doing things or improve on same.

Janice Bennett-Livingston

Jul 25th 2018
Dear Mr. Maschin,

We appreciate your feedback very much! It inspires us to keep trying to provide valuable information! Thank you for taking time to comment!

John C. Helmfelt

Jul 25th 2018
As I interact in many areas of industry and commerce I have found your info to be very handy to solve the daily problems that crop up.

Janice Bennett-Livingston

Jul 25th 2018
Dear Mr. Helmfelt,

Thank you very much for your kind words!

Tal Lorber

Jul 25th 2018
I am interested in training information, product updates, webinar invitations and blogs.

Janice Bennett-Livingston

Jul 25th 2018
Dear sir

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