Sofrigam’s Igloo pouch closes ‘last mile’ cold chain gap to patient

Rueil-Malmaison, France:- Temperature-controlled logistics and pharmaceutical cold chain packaging specialist Sofrigam S.A., has developed Igloo as an innovative solution to a gap in the cold chain that ensures the safety of temperature sensitive medicines.

Ensuring end-to-end integrity in the cold chain has become increasingly important over the past eight years, during which the number of heat-sensitive pharmaceutical products has increased by nearly 50%. Currently around half of all medicines are temperature sensitive, including vaccines, hormones, insulin and bio-derived medicines for multiple sclerosis, chronic inflammatory diseases, etc.

Last mile gap

However this increase in temperature sensitive medicines has highlighted a gap in the ‘last mile’ of the cool chain. While manufacturers and wholesalers have developed reliable and efficient temperature controlled logistics systems to ensure temperature-controlled storage and delivery from manufacture to pharmacists, there have been deficiencies in ensuring medicines are similarly protected between pharmacist and patient.

This requires personal storage pouches that are both fully insulated and can also maintain approved temperature outside a refrigerator for at last an hour during transport and travel.

“However, the insulated pouches which have existed on the market up until now do not comply with the French National Council of Pharmacists (FNCP) or pharmacy constraints,” say Sofrigam, which has devoted two years research and development to finding a solution.

Shortcomings

The French-based company developed its innovative Igloo cooling kit in direct response to a request from the FNCP for a solution to serious shortcomings in the last mile delivery chain.

“In particular, many of the pouches being used by pharmacies and patients had no eutectic gel packs inside to provide a cold source, inadequate insulation that limited cold storage to a few minutes, no real re-use potential and no regulatory approval or constraints. We have taken these problems on board when developing the Igloo pouch as a secure personal temperature-controlled transport and storage system,” said Sofrigam.

Igloo innovations

The first key component in the Igloo cooling kit is a pouch incorporating effective thermal insulation. The pouch is big enough to accommodate the vast majority of heat sensitive medicines on the market while remaining sufficiently compact to be easily transported by the patient inside a handbag, briefcase, etc.

The second component is an ultra-compact ‘cold source’, a eutectic gel cooling element that fits inside the Igloo pouch alongside the medicines.

Together, the two elements can reduce temperature inside the pouch to the temperature range of +2°C to +8°C that is needed to ensure cold chain compliance and maintain that temperature for at least one hour independent of refrigeration.

Certicold approved

This performance has allowed Igloo to gain Certicold Pharma approval.

An additional benefit is that Igloo is fully reusable, with the gel pack being capable of being refrozen in a refrigerator more than 50 times before needing replacement.

“This is a practical, light and easy to transport, fully reusable cooling pouch that keeps medicines safe for at last one hour – a considerable technical achievement for a product of this size,” says Sofrigam.

“Above all, it is a product that meets a major need: cold chain compliant personal transport of heat-sensitive medicines without affecting their quality or rendering them harmful,” the company adds.

Extensive development

The insulated cooling pouch with cold source is the fruit of two years of research, including extensive collaborations with laboratories, wholesale distributors, hospitals and pharmacies. It was necessary to carry out nearly 600 tests to develop the final Igloo solution and ensure full cold chain compliance.

While the current Igloo pouch is large enough to accommodate some 80% of heat-sensitive medicines on the market, Sofrigam is now working on development of a bigger version for more voluminous products.

Breakthrough product

The Igloo cooling kit represents a long-awaited innovation in the market for heat-sensitive medicines, allowing pharmaceutical companies to guarantee therapeutic quality of their medicines through to patient administration. The Igloo pouch is large enough to accommodate the vast majority of heat sensitive medicines.

Protecting cold chain medicines

Safeguarding the pharmaceutical cold chain for heat-sensitive medicines, such as vaccines, hormones and insulin, guarantees the integrity of medical treatments until they are administered. Once the medicine has been issued to the patient, it must constantly be stored at a temperature of between +2 °C and +8 °C in order to maintain its effectiveness.

About Igloo

Igloo is Sofrigam’s patented insulated packaging solution for storing heat-sensitive medicines in transit from the pharmacy to the patient’s home. It bears the Certicold Pharma* label as a guarantee of quality and efficacy in protecting medicines at specific temperatures of between +2 °C and +8 °C.

Sofrigam developed the Igloo cold pouch solution during 2015 in collaboration with healthcare professionals in response to a request from the French National Council of Pharmacists to provide an appropriate form of packaging with minimum built-in cooling capacity of 20 minutes. Igloo also satisfies the requirements of individual pharmacists for a cold transport and storage solution that is quick and easy to prepare and affordable to sell on or offer as added value for their customers.

The Igloo cooling solution comprises a complete kit of insulated pouch and eutectic gel to provide a cold source. Together, they can maintain internal temperature at between +2 °C and +8 °C for up to one hour.

The Igloo procedure is straightforward: the pharmacist supplies the medicine in the Igloo pouch (stored at +5 °C), which maintains it at the correct temperature for up to one hour (based on the conditions defined on the label) without external refrigeration.

The patient then simply places the pouch in the domestic refrigerator, which maintains correct temperature indefinitely.

Finally, the patient takes the Igloo medicine pouch to the doctor’s appointment or other outing, without any additional preparation and with no risk of the medicine freezing.

About Sofrigam

French-based Sofrigam S.A. designs and manufactures cool chain pharmaceutical shipping solutions and insulated boxes for the life sciences industries as well as for distribution and logistics companies.

The company was founded in 1979 by an industrial pharmacist and initially developed eutectic painkillers before specializing in the design and manufacture of insulated and refrigerated packaging, including pre-qualified insulated shipping and temperature management solutions. The company is headquartered in Ile-de-France with a production site at Arras.

Sofrigam offer solutions for the cold chain logistic problems experienced by the pharmaceutical industry. It offers a range of standard and made-to-measure thermal packaging products as well as customized services designed to achieve secure, cost effective and ecological cold chain logistics.

Sofrigam has become one of Europe’s leading cold chain specialists, sharing its expertise via seminars, publications and R&D collaborations. It also offers customized products and services designed to achieve cold logistics that are secure, cost-effective and comprehensively compliant.

Sofrigam partners with Ater Métrologie, a French-based ISTA and ISO 9001 certified laboratory that specializes in testing, validating and pre-qualifying temperature-controlled packaging and cooling systems. The laboratory carries out some 2,000 tests each year.