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Cold logistics: securing transport in the +15/+25°C range

29 April 2013

Regulations are becoming stricter: soon pharmaceutical laboratories will need to adapt their logistics to secure +15/+25°C transport.

Medication distribution best practices are being strengthened!

Best Distribution Practices are getting stricter on the +15/+25°C medication distribution circuit. The main directives have been published in the Journal Officiel and will become law in France in the coming months.

Which insulated shipping system to use for +15/+25°C transport?

Pharmaceutical laboratories will have to secure +15/+25°C transport

Annick Demouy, Pharmacist, tells us more:

"The European directives increase the safety, quality and integrity of the medication at all levels of the distribution circuit. Heat sensitive products are widely covered. The new Distribution Best Practices remind wholesalers of their responsibilities and put the accent on new themes: quality risk management, temperature and environment control, specific measures applicable to traders, etc.

It is therefore important for professionals to be able to prove that the solutions used for storage and transport maintain the temperature of products subject to the cold chain. The validation of processes is mandatory and is especially achieved by the pre-qualification of cold chain packaging. "

Which insulated shipping system to use for +15/+25°C transport?

Pharmaceutical shipping, +15/+25°C insulated packaging Most of the cold chain issues involved maintaining the +2/+8°C temperature thresholds, now, however, an increasing number of pharmaceutical products need to be transported in the +15/+25°C range. Now, this temperature range is much more complex than could be imagined. If protective covers provide safety from temperature variations, they are not always adapted to complex logistics circuits.

Sofrigam is carrying out research and tests to adapt its cold chain packaging to +15/+25°C transport. Depending on the product profile and logistics constraints there are several possible solutions: 

  • An insulated box with no cold source, such as the rigid icebox Plasibox® or the soft, heat insulated bag Sofribag®. This solution is suitable for moderate temperature profiles, or profiles that alternate hot segments above +30°C and cold segments below +15°C.
  • An insulated shipping container with 0°C gel packs . The Pallet Shipper Frizbox® can be used with frozen or non frozen gel packs for very hot profiles, or with non frozen packs for cold or moderate profiles.
  • An insulated packaging with positive PCMs. Phase change materials (PCM) with a melting point between +18 and +22°C are best suited to maintaining products between +15 and +25°C in hot and cold profiles.  Two types of PCM can be used: paraffins and hydrated salts contained in rigid bricks or soft packs. The heat insulated packing Sofribox®, combined with positive PCMs is an effective solution.

These three solutions are effective to secure +15/+25°C transport. The simplest and cheapest solution is the insulated shipping system with no cold source. 

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