Press Release – Sofrigam S.A
UN3373 Raises Stakes for Biological Substance Shipping
Contact Supplier: Sofrigam S.A
Supplier Press Release: UN3373 Raises Stakes for Biological Substance Shipping
Address: 212 avenue Paul Doumer, 92508 Rueil Malmaison, Cedex, France
Tel: +33 (1) 46 69 85 00
Fax: +33 (1) 47 25 98 44
DECEMBER 23, 2013
UN3373 Raises Stakes for Biological Substance Shipping
Rueil-Malmaison Cedex, France: – The development of UN3373 shipping regulations for Category B biological research materials has raised a new level of complexity for the many pharmaceutical laboratories, healthcare establishments, diagnostic laboratories and research centres that all transport thousands of human and animal samples each year.
French cold chain shipping specialist Sofrigam S.A. has developed an easy-to-use shipper’s guide to UN3373 and offers a series of solutions that make compliance easier than ever before for shipping by road, rail or air.
Transport of biological samples by air must comply with International Air Transport Association (IATA) regulations while transport by road is covered by the European agreement on international road transport of hazardous goods (ADR). In either case, shipping of infectious samples must comply with the UNO-developed guidelines included in UN2814 and UN2900, while non-infections Category B materials are covered by UN3373.
To comply with UN3373, packaging must be composed of three layers:
• A preliminary sealed packaging (recipient) that contains the actual material being transported.
• A secondary packaging, strong and sealed, that makes it possible to protect one or more primary recipients surrounded by sufficient absorbent material to absorb all the liquid in the event of a leak.
• An outer packaging used to protect its contents and guarantee the cold chain where necessary.
Each primary consignment must not exceed 1 litre for liquids, or 1 kg for solids. The maximum quantity of category B biological matter transported in a parcel is four litres or four kg. The parcel must be correctly marked, labelled and accompanied by the transport documents.
A pre-qualified insulated shipping packaging is essential for heat sensitive samples. Heat sensitive samples must be transported strictly compliant with the cold chain, to preserve their effectiveness. Depending on their stability, they are transported at between +2 and +8°C (or even +2 and +4°C) or below -18°C.
Laboratories, depositories and CROs use heat insulated packaging. During home care, qualified heat insulated bags are used to transport the product. On the return, the samples (blood, skin, etc.) are transported in UN3373 heat insulated packaging, from the place the sample was taken (hospital or laboratory) to the analysis laboratories.
Sofrigam has recently developed a line of UN3373 temperature-controlled packaging for the safe transport of clinical trials.
Chief among these, its Clinibox® packaging line guarantees the safe, temperature controlled transport of clinical trials (clinical samples, diagnosis samples or category B biological materials). It both guarantees compliance with applicable regulations covering the transport of hazardous goods (IATA and ADR) and compliance with the cold chain. The cold chain packaging is tested and qualified by Sofrigam’s partner, the Ater Métrologie laboratory – using the ISTA 7E profile for thermal performances, and a minimum height of 1.2 m for the drop impact test.
These UN3373 transport kits are composed of VIAL 650 pouches and a heat insulated box. The VIAL 650 pouch (secondary packaging) is certified 95 kPa by an IATA approved laboratory. It is divided into several separate compartments that contain a sufficient quantity of absorbent material and in which the tubes are placed directly. It thus complies with the tube separation requirement and the requirement for protection from leaks. As for the heat-insulated box (external packaging), it is manufactured using rigid polyurethane panels and cooled using cooling gel packs.
Clinibox® variants accommodate consignments varying from less than five tubes to as many as 25 vials at temperatures below -18°C for up to 72 hours with gel cooling and up to 96 hours, using dry ice.
Sofrigam says it can also produce UN3373-compliant temperature-controlled packaging to individual dimensions, depending on detailed customer requirements.
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 specialising in the design and manufacture of insulated and refrigerated packaging.
Sofrigam offers 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 customised services designed to achieve a secure, cost effective and ecological cold chain logistics.
Sofrigam has become one of Europe’s leading cold chain specialists. The company shares its expertise via seminars, publications and R&D collaborations. It also offers customised products and services designed to achieve cold logistics that are secure, cost-effective and comprehensively meet specific requirements.
Sofrigam is headquartered in Ile-de-Franc with a production site at Arras in Northern France.
For more information about UN3373 raises stakes for biological substance shipping, please contact Sofrigam directly.