Revealed: razor-thin margins of protecting heat sensitive medicines
JULY 08, 2014
Press Release | Sofrigam S.A
Monchy-le-Preux , France: – Maintaining the cold chain for heat sensitive medication is a high stakes business. Any break in the temperature controlled chain, even for a minute or two, can have disastrous consequences for the patient and expose manufacturers and suppliers to major financial losses. A minor temperature excursion of a few degrees outside the limits permitted by marketing authorization can render a vaccine or medicine ineffective – even toxic.
Few organisations are more aware of these uncomfortable truths than France’s Ater Métrologie laboratory. From its base in the village of Monchy-le-Preux, south of Arras in Pas-de-Calais, the laboratory conducts thousands of tests a year to establish the margins between success and failure in temperature-controlled packaging and cooling systems.
Laboratory director David Stienne explains that these margins can be razor-thin, recounting results on a recent test to find out how long unprotected products can maintain permitted temperature if cooling fails during storage or transport.
“We 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,” Stienne explained.
After fitting temperature sensors on the outer box and close to the product itself, researchers placed the whole package in a professional cooling cabinet and chilled it to +3°C for five hours. Then the package was taken out of the cabinet and exposed to room temperature of around 21°C while technicians monitored readings from the sensors. The results were shocking.
“The packaging exceeded the required +8°C temperature after only three minutes of exposure,” said Stienne.
“It took only one minute more for the ‘vaccine’ inside to exceed permitted temperature, also,” he added.
“So we were able to show that the temperature rise was very fast even after a prolonged cooling period. The implications are clear: that heat-sensitive pharmaceutical products must have effective and highly portable insulation packaging. Otherwise, there is a window of only a few minutes from being removed from the cool chain during which the product can be safely administered,” said Stienne.
Widening the window
Working in partnership with Ater Métrologie, French-based cold chain logistics expert Sofrigam constantly seeks to widen that window by developing packaging and temperature stabilization technologies that can accompany heat sensitive products ever further along the chain and down the ‘last mile ‘ to the end-user.
Sofrigam’s objectives are to help pharmaceutical laboratories, producers, health professionals and patients in mitigating the risks and guaranteeing the safety, quality and effectiveness of heat products.
The range of technologies and packaging solutions that are now available can be seen in one of the most important heat-sensitive products of all, insulin.
The Insulin dilemma
The imperative to maintain insulin at between +2°C and +8°C is a life-or-death issue for more than 350 million diabetics worldwide. For decades, one of the most important questions in medicine was how to maintain this vital cold chain from insulin production laboratory all the way into the patient’s home.
“Since the mid-1980s, companies like ours have been working very hard to pioneer new insulated packaging solutions and adapt them to insulin transport, extending all the way to dispensing chemists and even end-users to avoid any breaks in the cold chain,” said Sofrigam Marketing Director, Laetitia Perche.
“The stakes are high, as it only needs two minutes at room temperature for a heat sensitive treatment to exceed safe temperature without it necessarily being detectable on the product. Insulated or refrigerated packaging solutions are essential to conserve the treatment properties of insulin. Health professionals must therefore take care to protect heat sensitive medication at all levels of the cold chain, especially when delivering the medication to the patient,” she added.
One of Sofrigam’s most recent innovations is the Nomad cooling packaging line, purpose-designed for the transport of heat sensitive pharmaceutical products such as insulin by healthcare workers and patients. The Nomad line includes a refrigerated soft pouch to transport vaccines from dispensary to the patients’ home, preserving insulin and other heat-sensitive products for up to two hours at below +8°C, even without any cooling media.
Sofrigam has also developed new types of case to transport small batches of heat-sensitive medicines over “last mile” links in the cold chain, including Plasibox®, a rigid plastic icebox that is practical, easy to use, and robust and Textibox®, a rigid textile icebox that combines the thermal performances of an icebox with the ease of handling of a flexible insulated bag.
These insulated packaging solutions can be used with or without added cold sources such as cooling gel packs.
“The Nomad packaging range allows patients to transport their insulin in a pouch or in a vaccine cooler bag, from the dispensing chemist to their home, or when they are travelling,” Perche explained.
“Insulin can be kept for up to two hours using the Slim pouch, and up to 16 hours using the Thermotrousse cooling bag. Adding gel packs inside the packaging may be required, especially if the insulin has already been prepared in an injector pen, or in very hot weather.”
“Freezing insulin should, however, be avoided,” Perche cautioned. “To achieve this, the patient can keep the gel pack in the refrigerator before use. Flat gel packs can be placed inside heat insulated pouches if they are not in direct contact with the product.”
French company, Sofrigam S.A. designs and manufactures cool chain shipping solutions and insulated boxes for the pharmaceutical and biotechnology 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 solutions. The company is headquartered in Ile-de-France with a production site at Arras.
Sofrigam offer solutions for the cold chain consignment problems experienced by the pharmaceutical industry. It offers a range of standard and made-to-measure cooling 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.
Laetitia Perche, Marketing Director, Sofrigam SA
Tel: +33 (0) 1 46 69 85 43
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