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Pharmaceutical Manufacturing and Packing Sourcer

Play it Cool

As pharmaceutical and biological logistics spending booms towards an estimated $86 billion dollar industry by 2018, regulatory agencies have begun to place more scrutiny on the adherence of temperature requirements during transportation. The sector is racing to catch up to meet the needs of proper temperature management for a wider range of products, including refrigerated, frozen and control room temperatures that are being delivered through evolving methods such as mail orders. As new technologies and practices evolve to provide for the growing demand, it is important to understand their fundamentals in order to avoid misconceptions and be able to detect false claims.

During Shipping

With the availability of smaller, cheaper and less sophisticated temperature monitoring devices, it can be tempting to use them on a regular basis to determine conditions during transportation. However, with the wide variety for sale and the numerous variables that can impact the quality of their readings, these can be misleading. Most only measure the air temperature, which can vary by several degrees from the pharmaceutical or biologic’s actual temperature – especially if the product is liquid.

Some low cost indicators utilise chemical conversions to give a general idea if the desired conditions have been maintained. These devices have a broad accuracy relative to a tight range, typically of 2-8°C. Another downfall is that most require a set storage time within a specific temperature range before they can be used. Once they are ready, they must be maintained within the temperature range, otherwise false readings can occur. This is possible during packing or when the containers are opened at their destination, which could trigger an excursion reading when the drug is not even in contact with the indicator.

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Dr Jean-Pierre Emond, Chief Operating Officer of The Illuminate Group, received his PhD in 1992 from the University of Florida, US, where he is now a courtesy professor. Jean-Pierre was previously the Director of Cold Chain Research at the Georgia Tech Research Institute and has over 300 technical communications and 25 patents in packaging, transport and distribution.

Melissa Germain is the Chief Executive Officer of The Illuminate Group. Since 2008, she has served as the Director of the Academic Cold Chain Forum, where key players in the food and pharma sectors meet to discuss and solve issues in the cold chain industry and broaden their knowledge of temperature management. She graduated from the University of Florida, US, with a BSc in 2009 and an MSc in Agricultural and Biological Engineering in 2010.
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Dr Jean-Pierre Emond
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Melissa Germain
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