Cold chain temperature management

Cold chain logistics are more demanding than general temperature-controlled or ‘cool chain’ shipping and storage. In pharmaceutical and biotech logistics, cold chain temperature management requires maintenance of drugs, samples, vaccines, etc. at temperatures between +2°C and +8°C (+35.62°F to +48.4°F) from the time manufactured until final administration or use. In practice, cold chain temperatures can go as low as -80°C (-112°F).

The term ‘chain’ is used because it is a series of temperature-controlled links, defined by the World Health Organization (WHO) as ‘a network of refrigerators, cold stores, freezers and cold boxes organised and maintained so that (goods) are kept at the right temperature to remain potent during… transportation, storage and distribution from factory to the point of use.’

Thus the chain must remain unbroken. The products are ‘temperature sensitive and will spoil or lose compliance with regulatory standards if subjected to temperature excursions, either too warm or too cold. This means that not only must the goods remain within the cold chain temperature range but must be confirmed and audited as having done so. This is where IntroTech can assist, with a range of solutions that check, test and monitor a temperature controlled supply chain.

Cold chain management strategies

There are three principal strategies available to maintain a pharmaceutical or biotech cold chain within specified limit.

Monitor temperature with indicators

Where the product is vulnerable to exposure to temperatures outside of an acceptable temperature range, it needs to be monitored for the whole of its life within the chain to ensure that permitted temperatures were maintained throughout.

IntroTech supplies a range of economical indicators that can be attached to each protected product. These indicators make cold chain monitoring easy since they provide immediately visible confirmation that consignments have remained within compliance limits, along with tangible evidence acceptable for the audit trail demanded by some regulatory bodies.

Register temperature with data loggers

Data loggers use a different approach to cold chain management, monitoring the overall storage or shipping experience, rather than single excursions. In theory, a single logger could protect a whole consignment where goods remain together. The logger provides a door-to-door record of the whole temperature history of the journey over days or even months. IntroTech offers sophisticated yet inexpensive data loggers that automatically save and collect data and plug into a USB port, for a complete data download to generate an instant but comprehensive report.

Use wireless temperature management

Wireless temperature management follows the strategy of monitoring the storage or shipping environment, rather than the goods.

IntroTech’s wireless temperature management solution allows users to monitor an entire manufacturing or storage facility with 24/7 automatic and remote monitoring and recording pf ambient temperatures and other environmental conditions, together with a history of events such as door openings and adjustments. Wireless temperature monitoring can also be pro-active – alerting managers by e-mail, SMS or warning call when conditions exceed pre-determined limits.

Total Cold Chain Temperature Management

None of these strategies is exclusive. Elements of all three can be combined to construct a total temperature-controlled management regime, inspired by particular needs and context or existing best practice elsewhere. In either case, IntroTech can advise clients, drawing on its impressive experience as a Cold Chain Specialist to provide consulting and management know-how.

IntroTech experts can show how each element can be deployed to best advantage and how they can work in combination to provide total cold-chain protection so that product integrity remains intact and manufacturers remain in compliance with even the most rigorous GMP, GDP and other standards regimes, including end-to-end audit trail.

Resources

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Supplier Information
Supplier: IntroTech B.V
Address: Imbosweg 30, 7371 DD Loenen, Netherlands
Tel: +31 55 505 8383
Fax: +31 55 505 8333
Website: www.introtech.eu