When cold becomes the weak link and stability becomes the new standard

An international health & beauty organization ran into a problem during winter transportation within the GDP ambient range (15°C-25°C): despite the use of EPP boxes, internal temperatures during cold distribution trips in northern Europe dropped too quickly toward the lower limit.

Coolpack was asked to help think of a solution that:

• Reliable performance under winter conditions
• Easily incorporated into existing logistics
• is scalable for multiple countries and hubs 

The insidious side of ambient distribution

In pharmaceutical logistics, controlled ambient (15°C-25°C)) in winter is rarely about overheating. Instead, the real risk is unwanted cooling. Exactly that happened to a leading international retailer with thousands of stores in multiple markets.

During winter distribution trips through northern Europe, the outside temperature dropped to 0°C-7°C. As a result, the internal temperature in the EPP boxes dropped too quickly toward the lower end of the GDP bandwidth.
(GDP includes rules for safe and controlled storage and distribution of medicines, ensuring quality and traceability at all times).

That led to:

• uncertainty about product quality
• additional temperature controls
• operational disruptions
• Risk of comments or fines during inspections (fines can reach €150,000 per article violated)

In addition, there was no knowledge of how to safely and consistently warm up proprietary heat elements. Required warm-up times prior to use, maximum temperature limits and workflows were unknown: a GDP risk in itself.

The question behind the question

During the initial contact, it quickly became apparent that the company needed more than just a well-functioning PCM element. There was also a need for insight:

• maximum heating temperature (safe to 35°C)
• warm-up time of a pallet (±1000 kg PCM)
• the effect of mass on heating times
• the proper warming agents (thermal blanket, warming chamber, oven)
• optimal configuration (number of plates to be used per box)
• validation data from a certified testing facility
• temperature loggers for internal approval and customer proof load

In short:

Coolpack was asked to help think about one central question: How do you create a stable, controlled supply chain without changing logistics?

The solution: passive conditioning with Coolpack PCM +22°C

Coolpack proposed a solution that perfectly matched the existing process: a controlled, validated and scalable system that fully meets GDP requirements.

• EPP box with intermediate panel. – For clean and safe separation between PCM and product, fully GDP compliant.
• ½ gastronorm PCM trays filled with PCM +22°C – The phase transition at +22°C prevents cooling in a natural, energy -efficient manner.