The necessity of robust temperature packaging is critical as more biotechnology products are being brought to market globally. This paper will outline the steps necessary to develop temperature sensitive packaging. Development of temperature sensitive packaging is a complex process, especially for new products. The steps to develop robust packaging start and end with good design control. There are many regulating bodies that can give guidance on this topic, but the majority of the work remains with the company. Well defining the design requirements dramatically shortens the design time of any packaging. Acceptance of any developed packaging must include process verification that all product release criteria are still met at the end of the product shelf life. Once the package has been tested, and meets all of the design requirements, validation testing can begin. Validation consists of testing the package in its final configuration, against worst case scenarios. A successful temperature sensitive package would hold the required temperature range for greater than the duration of the shelf life. All validation testing must incorporate high and low temperature challenges to simulate the year round shipping that the product will face. Following these steps will aid in development of a robust package that will protect your product during transit to the final destination.
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