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break in the cold chain can have disastrous consequences on the patient and
expose health professionals to major financial losses. A movement of the
temperature outside the zone permitted in the authorisation to sell can change
the treatment, render it ineffective or toxic.
The experience of David Stienne, the director of the Ater Métrologie metrology laboratory (Sofrigam partner) shows us that there is no room for manoeuvre:
carried out a test on a simulation vaccine. The active product was replaced by
water, but the packaging was strictly identical to the vaccine on the market:
an outer cardboard box and a heat moulded plastic blister enclosing the
vaccine. We fitted one sensor inside this plastic packaging to be as close to
the product as possible, and another on the outer box. Then we placed the whole
in a professional cooled cabinet at a constant temperature of +3°C for 5 hours.
We removed the product from the cooling cabinet to expose it to a surrounding temperature between 20 and 22°C. The packaging exceeded the required 8°C temperature after 3 minutes of exposure, while the vaccine inside reached it in 4 minutes. We were able to show that the temperature rise was very fast and that during the period it was stored in the cooling cabinet the temperature was stabilised at 3°C".
"The exposure of a vaccine must not exceed 4 minutes"
professionals must therefore take care to protect heat sensitive medication at
all levels of the cold chain, especially when delivering the medication to the
Cooling packaging systems for patients are often difficult to use. Preparations that require temperature rises, stabilisations and "antifreeze" separation accessories are too complex for patients. Now the patient is at the heart of the cold chain and needs to know the requirements for the conservation of heat sensitive medication.
Sofrigam has developed the Nomad cooling bag line for patients. Effective, aesthetic and very easy to use, it can easily be part of their daily routine. Patients can prepare their packaging in less than 30 seconds. All they need to do is to place a -20°C gel pack directly into the insulated bag without any temperature rise period. Depending on the models, conservation time can vary from 2 hours to 15 hours for volumes from 2 to 15 litres.
"The use of this bag is so simple that its user manual can be printed on an A5 format page in the form of pictures like a cartoon, with no text. " explains Vincent Bailleul, Packaging engineer at Sofrigam at the origin of the project.
"The Nomad bag: temperature-controlled packaging solution for heat sensitive medication"
→ These products are on sale at www.coldshop.com
Since 2009 Sofrigam has been investing in communicating to health professionals and patients: we are meeting hospitals, dispensing chemists and patient associations. We inform and train them on cold chain requirements and make them aware of the consequences of the failure to respect cold chain constraints.
Sofrigam is also a member of the AFF-SFSTP* "last mile" sub-committee, the works of which are to propose concrete tools and solutions suited to health professionals who deliver or administer pharmaceutical products to patients (dispensing chemists or hospital pharmacists, healthcare staff, pharmaceutical laboratories). The objective? To guarantee the respect of the cold chain for medication from a quality point of view, right up to the patient.
* (Association Française du Froid – Société Française des Sciences et Techniques Pharmaceutiques)