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Validation of cold chain procedures suitable for distribution of vaccines by public health programs in the USA.

To enhance quality assurance of vaccine distribution by public health programs in the US, various methods for packing vaccines were validated. Validation involved both tests in an environmental chamber and actual shipping of packages by commercial overnight delivery service. Dry ice was used with vaccines needing to be kept at temperatures lower than -14 degrees C, and water-based cold packs with other vaccines. The latter could be used in two ways. When frozen, and placed over two or three faces of well-insulated boxes, assortments of vaccines were kept cold but not frozen for 2 days or more. However, packages with -15 degrees C cold packs may reach < 0 degree C. When cold packs at refrigerator temperature cover four to six faces of well insulated boxes, vaccine freezing in winter conditions or warming in temperate conditions was slowed considerably. These approaches, which require materials costing less than approximately 1% of the cost of the vaccines they protect, provide examples of packaging suitable for overnight delivery of vaccines in the US in different seasons.

Cold Temperature↗

Crohn's disease: the cold chain hypothesis.

A recent published hypothesis proposed that Crohn's disease was provoked by infantile exposure to micro-organisms that can survive refrigerator temperature. A case-control study was accordingly devised. The mean age at first fridge was 5.6 years amongst 88 patients with Crohn's disease, 5.5 years in 88 patients with ulcerative colitis (UC) and 7.6 years in 88 controls, but a majority of individuals had always been exposed to refrigerated food. Differences were more striking in subjects aged above the median (10.3, 10.9 and 15.0 years for Crohn's disease, UC and controls, respectively). This support for the hypothesis reached statistical significance for those with Crohn's disease compared to the controls (p=0.045).

Adolescent↗

The immunisation cold chain. Why is it so hard to get right?

BACKGROUND: Although the standards for vaccine storage required for accreditation of general practices, and the Guidelines for Australian Immunisation are widely available, all research to date suggests that in Australia compliance with these standards has not been readily achieved. OBJECTIVE: The New South Wales Central West Division of General Practice (NSWCWDGP) and the Public Health Unit of the New South Wales Mid Western Area Health Service (NSW MWAHS) worked together from 1999 to 2001 to produce an intervention that would gather information about current vaccine storage, and provide practical help to storage sites which were not complying with accepted standards. DISCUSSION: Cooperation between a general practice division and the public health unit can deliver coverage of 100% of vaccinators in a large geographic region. We have demonstrated that the lack of a designated person to take on ultimate responsibility for vaccines at a site is associated with less chance of achieving safe storage. Persistent difficulty in 'getting it right' has been documented. One new measure we have suggested and trialled is the installation of affordable commercial thermostats in the domestic refrigerators that are now widely used. Another is the piloting of a general practice division administered mailout program of temperature dataloggers to document the ongoing compliance of vaccine storage sites with accepted standards.

Australia↗