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European Pharmaceutical Contractor
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Continuing globalisation of operations in the pharmaceutical industry has greatly accelerated the need for new types of validated temperature-controlled packaging (TCP) that can offer a variety of different options. Due to a vast increase in the global traffic of infectious substances, diagnostic specimens, vaccines and blood products, there has been a growing need for TCP operating at parameters from -500C to +370C. These products are being employed over increasingly longer distances, through more variable temperate zones and through an expanding number of jurisdictions in ever-extending warm and cold chains.
Both warm and cold chains offer a system of ensuring product quality and safety up until it reaches the end user. The 'chain' refers to each stage in the storage and shipping of the product, which is joined to the other links by documentation and recording. As the chains involved in temperature-controlled shipping have increased, so have the demands made on TCP. Ever-increasing regulation is also playing a major part in this process. It is axiomatic that the efficacy of many temperature-sensitive medicinal products may be compromised if they are permitted to remain outside of their specified temperature band, and it is for this reason that regulatory bodies keep an ever tightening grip on the procedures and processes of good manufacturing and good distribution practice. The needs of both pharmaceutical professionals and the demands of regulators are therefore jointly driving the designers and manufacturers of TCP. The difficulty of this task is illustrated by the fact that the EU alone has no less than 15 different regulatory bodies.
To compound this point, a third element to consider is the ongoing need to reduce cold and warm chain costs without compromising the quality of the final delivered product. This can be approached in a number of different ways. The options include developing materials that increase the payload of a shipper, using materials that can allow it a longer shipping time, thus reducing transport costs, or by producing a multi-trip return-to-base (RTB) unit that in effect transforms transit packaging from an operational cost into a capital investment.
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