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The International Safe Transit Association’s Pharma Committee published a guideline on the passive thermal packaging qualification process.
The International Safe Transit Association (ISTA) Pharma Committee is looking for feedback from the life-science’s industry on a technical paper that offers a guideline for the passive thermal packaging operational qualification process. The guideline, which is the result of a collaborative effort between life-science companies and suppliers, defines minimum requirements and aims to drive standardization for packaging providers and life-science companies.
ISTA says that the guideline will simplify comparison, ensure that solutions meet testing and quality expectations, enable further innovation by making expectations clear, and streamline the review process. Although other guidelines exist, according to the March 26, 2020 press release, the committee aims “to provide users with a how-to guide to achieve success on important industry topics while allowing users to work within their own internal procedures. We believe the level of detail beyond the suggested industry best practice is the decision of the primary stakeholders of the temperature-sensitive product and based on each organization's risk acceptance.”
ISTA’s deadline for comments is April 30, 2020.