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Managing the Risks of Temperature Excursions

Baxter’s voluntary recall serves as a reminder of the importance of managing life science product temperatures through the supply chain.

Managing the risks of temperature excursions is of vital importance for many life sciences products.
Managing the risks of temperature excursions is of vital importance for many life sciences products.

The subject of temperature excursions comes up naturally at most “cold chain” industry events. That was certainly the case at the Global Forum 15th Annual Temperature Controlled Life Science Supply Chains where several presenters discussed managing excursions.

One example was Chris J. Anderson’s Sept. 28 breakfast briefing, “USP<1079> and the Evolution of Good Distribution Processes: Enhancing Quality Assured Processes to Maintain Product Quality and Supply Chain Integrity through Advanced Risk Mitigation Techniques.”

Anderson, Director, Quality Systems, Cardinal Health, and USP Packaging and Distribution Expert Committee Member, USP <1079> Sub-Committee Co-Chair, U.S. Pharmacopeia, noted that the guidance is evolving to make it more effective without overcomplicating or alarming supply chain logistics firms, 3PLs, etc.

“There needs to be better education on all these processes so we can better maintain the efficacy of temperature-sensitive medications, especially when we consider biologics and combination products,” Anderson said. “We need to stop freezing vaccines and baking biologic products.” He pointed to the following concerning examples:

• Influenza vaccines frozen during distribution, causing many to blame pharmacists even though they likely had no idea anything was wrong with the medications.

• Inadequate refrigeration equipment that provides no temperature readings—or perhaps inaccurate readings—much less an alarm to indicate that product temperatures are moving beyond their appropriate range.

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