TAP For CRT - Challenges Due To Product Temperature Criteria

By Ken Maltas and Iftekhar Ahmed

There has been significant discussion over the past few years around TAP (temperature-assured packaging) for CRT (controlled-room temperature). Manufacturers and regulators have not yet decided how they want to handle this type of product, although some countries, such as Saudi Arabia, have already mandated that CRT products be shipped in proper TAP. As with refrigerated products, the regulations vary from strict label claim to acceptance of excursions with stability data. A couple of major questions have to be asked before the individual manufacturer or the industry can decide how to design the TAP. The first question is what temperature is going to be used. CRT has been defined as narrowly as 20° to 25°C through USP (United States Pharmacopeia), 15° to 30°C in some cases, and as broad as 5° to 25°C. To make the temperature decision, the manufacturer must look at its labeling and stability data to see what the company can support as well as regulations around the world. After this decision, the manufacturer must then decide what product needs to be packaged and controlled at what temperature. This decision is crucial to the cost of the package and potentially the profit margin on these products.

Used with permission from Life Science Leader magazine.