Maintaining the Cold Chain - Pharmaceutical Technology

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Maintaining the Cold Chain


Pharmaceutical Technology


New to the US market is a flexible insulated packaging specialist headquartered in Italy. Already in use by several vaccine makers, the multilayer metallized film–foam–opaque film bags can be customized with full-color printing in as many as 10 colors. Bags are available in two stock sizes (20 X 25 cm and 30 X 35 cm) as well as custom dimensions and can incorporate airtight reclosable zippers, an integral refrigerant and die-cut or molded handles (CrioMED Plus insulated pharmacy bag, Imball Center S.r.l.-Termika.us, Roswell, GA, http://www.termika.us/).

A controlled-temperature system consisting of a cooling device, shipping carton, and vacuum-insulated panels maintains products at 2–8 C. Relying on evaporative cooling technology to pull heat away from the product, the self-contained package incorporates a push-button–activated cooling device in the lid, thereby eliminating the need for refrigerants and reducing the size of the package by as much as 70% compared with traditional insulated shippers using EPS foam and gel packs. With weight savings also likely, the system tends to lower shipping costs (NanoCool system, NanoCool LLC, Charleston, SC, http://www.nanocool.com/).

Some controlled-temperature shipping systems are specifically designed for certain modes of transportation. A system that protects temperature-sensitive air shipments won a Cold Chain Management Excellence Award in October 2005 from the International Quality & Productivity Center (New York, NY, http://www.iqpc.com/). The reusable containers, which are available in three sizes from a Sweden-based company, feature active temperature control (Envirotainer, Envirotainer Inc., Irving, TX, http://www.envirotainer.com/).

Some suppliers of cold chain management products also provide testing, design, and certification services. Temperature studies can be done with dry ice, gel packs, or shipment simulation (temperature testing, Therapak, Irwindale, CA, http://www.therapak.com/; package qualification and testing, Cold Chain Technologies' Cold Chain Laboratories; cold-chain management validation and qualification services, Envirotainer Inc.; and custom design services, Cold Ice, Inc.).

Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684,

References

1. Parenteral Drug Association, "Technical Report No. 39: Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment," J. Pharma. Sci. Technol. 59 (S-3), (2005).

2. Health Canada, "Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUIDE-0069)," (Health Canada, Ottowa, ON, Canada, 2005), http:// http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069_temp_control_dproducts_storage_transportation_ltr-doc_e.html, accessed Feb. 15, 2006.

3. H. Forcinio, "Packaging Helps Protect Temperature-Sensitive Products," Pharm. Technol. 28 (30), 36–42 (2004).

4. H. Forcinio, "Cold Chain Concerns," Pharm. Technol. 29 (4), 44–50 (2005).


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