Pharmaceutical and food companies all grapple with the challenges of maintaining their cold chains. Increasing regulatory compliance, customer demands, global market competition, and internal pressures to reduce costs are just some of the challenges pharmaceutical companies face today.
Andrew Meyers, Managing Director of Global Cold Chain Solutions, has been working closely with some of the major pharmaceutical companies in Australia and Europe to assist these companies to achieve an efficient and compliant cold chain.
“When we think cold chain, we should not only think about products that need to be maintained at +2 to +8ºC temperatures. It is important to take a wider view and consider products that need to be store below 25ºC. Hence the new terms that are becoming part of the Cold Chain vocabulary: ‘Ambient Temperatures’ and ‘Controlled Ambient’."
Also it is generally a requirement of most regulatory standards to conform to the labelling and storage directions stated on the product outer packaging.
At present there are no uniform global definitions or standards for these terms. New products emerging on the market contain labels suggesting that ambient could comprise any one, or all, of the following temperatures:
- +10ºC to +25ºC
- 0ºC to +30ºC
- +10 ºC to +30ºC
- Store below +25 ºC
- Store below +30 ºC
Andrew Meyers is a committee member of the newly-formed Australian Working Group on Temperature-Controlled Logistics. As a result of this lack of information and clear guidelines for Australian companies involved in manufacturing and distributing temperature-sensitive products, the group has undertaken a project to develop guidelines to assist industry. Preliminary classification of cold chain temperatures has been developed as follows: