Phase Change Material, Cold Chain Regulators Quick-List, and New Webinar on Risk Management

Warehouse cold chain
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Piritta Maunu
Life Science Industry Expert
Sep 12th 2014
Industrial Measurements
Life Science
Science & Sensing Technologies

This week, our new Regulatory Expert Piritta Maunu answers a question on Phase Change Material and regulatory bodies that are involved with cold chain. PLUS, we advertise an upcoming webinar we are giving on October 2, 2014, 1 PM Eastern: "Risk-Assessment Strategy for Validating Environmental Monitoring Software."

HI Piritta,
I am trying to figure out what agency provides regulatory guidance or recommendations for packaging types and PCM*. Are there any publications you can refer me to? Finally, can you refer me to the US and European regulations that would prevent paraffin-based PCM's being used in transportation (air and ground) because when they turn into liquid, they are flammable? I appreciate any guidance you can offer!
With regards,
Dr. P

*Phase change materials (PCM) use phase changes (ie: solidification, liquefication, evaporation or condensation) to absorb or release latent heat at relatively constant temperatures. The materials undergo changes, such as freezing or melting, which have an associated latent heat value. Common PCMs include salts, fatty acids, and paraffins.

Piritta Maunu answered

 

Dear Dr. P,

Thank you for reaching out and thank you for reading our articles! The type of packaging and PCM used in temperature-controlled shipping is dependent on the profile of the products being transported. And because this is also dependent on the temperature requirements for the particular products, I can't give specific advice; it really changes from case to case (i.e. whether your product storage specifications are CRT, +2…+8°C, or < -15 … etc.). Packaging and PCM are selected by the organizations that are part of the distribution chain, e.g. by production, packaging, distribution managers, clinical trial center personnel or quality personnel. After selecting the appropriate packaging and materials, both the transportation package and distribution chain should be validated by using e.g. trial shipments that mimic the actual shipment. Then, the temperature within the package should be monitored throughout the distribution chain with data loggers or other temperature monitoring products.

I'm sorry to tell you that I'm not aware of any published guides or regulations that instruct on the type of packaging and PCM to be used. But the most important item here is to select the type of materials that ensure that the required distribution/storage temperature is maintained throughout the whole chain and the temperature data for this chain exists. In this way, we are able to guarantee that temperature sensitive products have not altered or perished during the distribution chain.

BLOG-IMAGE-UPS-Vaisala

Regarding your question about paraffin-based PCM's that are flammable when liquefied, there are several documents in this area that you can take into account (e.g. certificates of trusted partner/company, warning markings…). This question is out of my knowledge area but I have listed here some Organizations, Associations and their publications where you are able to find more information about using PCM's in air or ground transport:

Also, a quick search on academic documents on Phase Change Materials generated these articles. (Some are for purchase.) Note - I haven't read them so I can't speak to the accuracy or credibility of the articles, but offer them only for your consideration.

I hope this is somewhat helpful! We have four other articles that touch briefly on cold chain guidance and recommendations from USP, ISTA, PDA and FDA/ICH .

Thanks again for contacting us! Please email me if you have other questions!

BR,
Piritta
Regulations Expert, Vaisala Life Science

BLOG-IMAGE-Drugs-Supply-Chain- Vaisala

 

Author

Piritta Maunu

Piritta Maunu

Life Science Regulatory Compliance and Industry Expert​

Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions for FIT Biotech. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.

 

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