Maintaining Product Integrity using dry-ice in a unique pack-out at -60°C

Situation

Tower were asked by a leading global biotechnology company to create and produce a cold chain solution in order to meet the unique temperature compliance need of its biological oncology product. The supply chain was highly complex with the client requiring the expertise of several CMOs across different continents with the assurance of control of their supply chain from API to finished product.

The client required Tower to design a unique and bespoke temperature controlled solution, as the incumbent product and process was insufficient and failed the supply chain. The API required storage below -60°C however the existing primary packaging failed due to the uncontrolled exposure to dry-ice.

Manufacturers of primary packaging assume that their packaging is treated and used in the same way regardless of temperature demand when often packaging may not fundamentally be appropriate and often the manufacturer lack the correct information from clients. This is why the product design team at Tower work to control and protect both the handling of primary packaging and critically the product being shipped.

The criteria posed were as follows

• Product had to maintain the product temperature between -80°C and -60°C for 120 hours
• The solution had to physically restrain the product regardless of the amount and quality of dry-ice
• With an average ambient temperature of 30°C
• Robust primary packaging to withstand both extreme temperatures and the rigors of a multifaceted global supply chain

Outcome

The KT400D Tower Flexi Fit Ultra container was conceived by Tower through an extensive R&D process working closely with its client. The solution employs a unique pack-out using dry ice technology with a robust and tough outer benefiting from a built-in data-logger. This class-leading solution is 100% reusable.

Conclusion

The client reported that no temperature excursions have been reported across their supply chain. The KT400D Tower Flexi Fit Ultra has since been used across multiple clients and across a wide range of ambient conditions and fits a unique demand for Tower’s biotechnology clients.