A Potential Revolution For Passive Shipper Selection

The selection process of passive shippers intended to maintain a specified range of temperatures from the point of origin to the destination has become increasingly complex with the introduction of stronger regulatory requirement s and continued advances in technology.

Once an engineer has identified the requirements of the cold chain, the next step is to choose a specific piece of equipment that has the capability to meet these requirements. For any specific lane in your cold chain, there are many technologies as well as vendor possibilities with similar technologies. In order to make a decision, the engineer will initially use heuristics to eliminate many of the potential candidates — for example, material of construction, cost or ease of use. Only then will exhaustive testing begin. But which thermal profile should be chosen? And will it be too challenging for your lane? Or worse yet, what if it is not challenging enough?

In a recent Pharmaceutical Commerce1 article, a handful of bright engineers, including my partner, Paul Harber, introduced a concept used in other engineering disciplines, one that could revolutionize the selection of passive shippers best designed for your specific lanes. Once the list has been narrowed in this way, the engineer seeks a performance curve for the equipment. If you have a reasonable amount of ambient temperature lane data (or even access to historic data in your route), you can very quickly review performance of multiple technologies and vendors. The secret? A performance curve for your choices in both technology and vendors.

The ambient lane temperature profile represents the thermal challenge that the container must meet. The performance curve quickly identifies the expected duration that the container can operate for a given ambient temperature profile. When a performance curve is constructed, it could be used in exactly the same way as performance curves are currently used for other engineered systems. In order to decide if a container is suitable, the customer requests the performance curve from the vendor. A performance curve that defines shipper capability allows the customer to quickly and easily determine if the container can satisfy the thermal requirements for the ambient temperature profiles in specific lanes.

A properly integrated cold chain ensures regulatory compliance, product quality, and patient safety by providing a multi-layered approach that combines best practices of process validation, systems qualification and risk assessment with the most applicable monitoring, controls, and packaging technology aligned with the latest cGMP quality management systems guidance. Adopting the use of performance curves similarly used by other industries is another step forward towards fully integrating your cold chain management systems.

The complexity of the logistics network results from financially-driven choices in manufacturing. Most modern manufacturing networks are global, single-sourced, and located in tax-advantaged locations with little local consumption. The transport of final drug product to the initial storage location is typically required. The manufacturer has very little direct control after manufacture and initial storage of finished drug product because most channels of distribution contain wholesalers, distributors, or other intermediaries. Selecting the correct thermal packaging that balances costs and risks is one of the most difficult tasks in the healthcare supply chain because of the sensitive nature of the product and the complexity of a modern logistics network.

Cold chain logistics is becoming a riskier business. Some of the factors range from longer supply chains and more sensitive products to limited infrastructure and extreme weather conditions. When using performance curves in risk mitigation plans, we must look at factors such as, do companies have the protection methods in place for getting clinical trials shipments to emerging markets, rather than trying to have the right packaging and transportation solutions for all types of products and regions.

Modality Solutions and the authors of the Pharmaceutical Commerce performance of passive shipping containers’ article are preparing a workshop for the IQPC Cold Chain Global Forum in September 2016. The workshop will examine the current approaches of the selection of passive shippers and how they can fail. Using the concept of performance curves for shippers and comparing it to specific lane data for use in transport lane qualification is one use of this approach to defining performance of thermal shippers for the pharmaceutical cold chain. The development of thermal qualification profiles from lane data and the selection of a passive shipper suitable for use in a specific lane using new techniques for transport lane qualification can be revolutionized by the development and use of performance curves.

The workshop will cover:

a) What are the seven guiding principles for choosing a method for identifying OQ test temperature profiles?

b) What is a container performance curve, and how is it created?

c) What should an optimal performance curve look like?

d) How can you use performance curves to design passive containers?

e) Can you use performance curves for designing seasonal packouts?

f) Can performance curves be used for evaluating container performance?

g) How can you use performance curves for managing shipment delays?

h) What are the limitations of the performance curve approach?

1McGarvey et.al. January / February 2016: A new way to look at the performance of passive cold-chain shipping containers. Pharmaceutical Commerce, Supply Chain Logistics, pp. 21-22.

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