Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

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.

List: Digitalization Companies From PACK EXPO
Looking for CPG-focused digital transformation solutions? Download our editor-curated list from PACK EXPO featuring top companies offering warehouse management, ERP, digital twin, and MES software with supply chain visibility and analytics capabilities—all tailored specifically for CPG operations.
Download Now
List: Digitalization Companies From PACK EXPO
Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging