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| home > pmps > spring 2004 > how new materials and technologies are putting validated shipping within reach of everyone |
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 PUBLICATIONS |
Pharmaceutical Manufacturing and Packing Sourcer
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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. |
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