Cold chain

Health and safety requirements continue to become stricter in the maintenance of the cold chain and the latest regulations should be adhered to. 

The cold chain principle of food handling and distribution is that the product will be maintained at suitable conditions all the way to the point of sale. This requires transport and various kinds of storage. 

In many catering applications, cooked meals are produced in one point and have to be transported to another place where they are eaten. Some examples are transport of cheese, salads, frozen deserts, confectionery, or fish. PCMs containers could also be used to avoid breaking the cold chain during transportation of precooked meals, foie-gras, smoked salmon, milk derivates, ice-cream, and many others. 

Storage up to 20 days at a maximum temperature of 5°C, few fluctuations of temperature, continuous cold chain, humidity 50-85%, clean packing material, good air circulation. 

NFV does not need refrigeration and can be used as a PI alternative in places without a cold chain. 

There are insufficient data to detect differences among currently available RTV-boosted Pis (ATV/r, FPV/r, IDV/r, LPV/r and SQV/r) and the choice should be based on individual programme priorities (see text). In the absence of a cold chain, NFV can be employed as the PI component but it is considered less potent than an RTV-boosted PI. 

On the basis of current research it may be possible to speculate about future directions for vaccine development. For example, controlled-release drug systems are well recognized and have appeared in clinical practice. It seems reasonable to ask if the same technology could be applied to vaccines. What would be ideal is a vaccine that only required a single dose which incorporated that booster dose so often necessary for complete effectiveness. If this in turn was combined with heat stability to overcome the problem of maintaining an effective cold chain for distribution in tropical countries we would be well on the way to providing an ideal product. 

Ensures adequate vaccine/prophylactic medications and supplies are taken to the clinic site. Maintains all supplies in a temporary warehouse on site and maintains vaccine cold-chain. Issues supplies/vaccines to supply distributors as required. Sees that all unused supplies and vaccines are transported back to point of origin and properly stored. 

A product or reagent that must be kept cold during transit and storage most often between 4° and 8°C. See Elliott, M.A. and Halbert, G.W., Maintaining the cold chain shipping environment for phase I clinical trial distribution, Int. J. Pharm. 299, 49-54, 2005 Streatfield, S.J., Mucosal immunization using recombinant plant-based oral vaccines. Methods 38, 150-157, 2005. 

Therapeutic peptides and proteins are far more stable in the solid state compared to the liquid state. Delicate proteins often significantly degrade within hours when held at room temperature in the liquid state. All FDA approved therapeutic proteins for human use are injectable products, except Exubera the first inhaleable insulin. A recent survey has shown that 12 of the 30 commercial products are available only as dry powder and 28 of the 30 require refrigeration (49). Not having to refrigerate a pharmaceutical product greatly increases convenience and significantly reduces transportation and distribution costs, this is particularly true for vaccines, where an alternative to break the so called distribution cold chain is badly needed in third world countries. 

Establish efficient systems for the procurement, storage and distribution of drugs and vaccines including a reliable cold chain for the latter. 

Special care should be exercised when using dry ice in cold chains. In addition to addressing safety concerns, it is necessary to ensure that the material or product does not come in contact with the dry ice, as this may adversely affect the quality of the product, e.g. as a result of freezing. 

A patented variation of the classical lyophilization technology is applied as VitriLife (3) wherein the product is lyophilized using a mixture of sugars this formulation can be prepared in much shorter time and is different from classic lyophilization in that no sublimation is involved and the product undergoes fast drying the resultant product can be kept at room temperature, obviating the need for the cold chain for these products. The method has been applied to cholera vaccine and other vaccines and is still under development. 

The materials were shipped in a polystyrene box and were kept cool by means of cooling devices. A cold-chain monitor was included in the parcel for recording of the temperature during transport. Check this monitor directly after receipt of the parcel. Compartments B, C and D must not show any discolouration (blue colour), if so, please contact the shipper directly. Compartment A may be coloured blue. Coloration of this compartment means that the temperature during shipment was greater than 10°C but less than 34°C for a short period of time. This should, however, have no effect on the results obtained with the materials. More information on the cold chain monitor is presented in annex C of the report. 

Bogh-Sorensen, L. 2000. Maintaining safety in the cold chain. In Managing Frozen Foods, ed. 

All thermoliable products must be distributed under temperature-controlled conditions to maintain the cold chain. 

Another specific problem of protein therapeutics is their relative instability, which calls for strict regimens in storage and handling. In principle, protein drugs need a cold chain that is maintained from the manufacturing plant until administration to the patient. The CHMP has indicated that biosimilar producers need to show that they control the distribution of their products. 

The development of the biosensors has been enhanced by encapsulated biosystems used to control environmental pollution, food cold chain (abnormal temperature change). 

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