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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.
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. "
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:
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.