Bayer Warms Up to Cold Chain Supply

Careful validation and quality assurance work, and close collaboration with vendors, was a “win-win” for all who helped develop Bayer Biological Products’ cold chain solutions.

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Bayer teamed up with Envirotainer
to achieve its current global shipping
solution. Shipments using the jointly
developed I-box have provided excellent
flatline results in the 2° to 8°C range.

By Jim Bacon, Director of Global Supply Chain
Bayer Healthcare - Biological Products Division

In the comedy Planes, Trains and Automobiles, Steve Martin and John Candy bumbled and cajoled their way across the country. The film’s enough to send shivers down the spine of anyone involved in the pharmaceutical cold chain. Pharmaceutical and biological products also move over land and sea, and through the air, but their journeys are dead serious, and these sensitive, valuable materials must be kept at optimum temperature throughout their travels.

The increased pressure to ensure cold chain integrity has made developing and controlling shipping conditions a top priority for pharmaceutical manufacturers, and many are responding with innovative guidelines and solutions. Working closely with in-house quality assurance and validation teams and vendors, Bayer Biological Products was able to develop an all-season containment design, using a “worst case” scenario to ensure that product integrity would hold up even at extreme temperatures. In this article, we’ll discuss the approach we took and what we found to be “best practices.”

Vendor partnerships critical

When designing a cold-chain solution, it’s important to focus on practicality, which equals ergonomics plus economics.  To put it bluntly, the best design is worthless if your company can’t afford to ship it.

The key to cold-chain success is selecting a vendor that has handled a wide variety of projects for different customers. Companies whose hands are tied by proprietary agreements can only provide limited benefit. Cultivating a good relationship with the vendor is essential, as the company needs to understand your specific needs and the interplay between your product, its packaging and the shipping environment. It’s also important to find a solution that you will be comfortable with, since changing strategies can be extremely costly.

Bayer worked with one design and testing vendor to devise and carry out an effective cold-chain packaging solution. The company helped us create a structured approach to design and execution, and then worked with our Quality Assurance (QA), Validation and Customer Operations staff to complete the process.

The result was the following step-wise approach.
  1. Establish a test profile based upon shipping requirements, current packaging methods and proposed shipping systems.

  2. Conduct baseline tests of current and proposed shipping systems with test profile(s) created in step one.

  3. Analyze and adjust packaging as needed. Create a test protocol for approval.

  4. Approve protocol and qualify shipping systems.

  5. Based on final report and approval, implement the system and generate the standard operation procedures (SOP) and training required.
The first step was to develop testing parameters. When anticipating shipping conditions and ambient temperature profiles in all the global markets we serve, we found it best to apply our product stability knowledge to real-life examples. For example, if we knew that a product could successfully withstand temperatures of 2°C to 25°C for 30 days, we determined what ambient temperature range the shipping container might experience on the trip and used that figure to calculate what would be needed to keep the product within its temperature limits.

Following Parenteral Drug Association (PDA) recommendations, we tested seasonal extremes by assessing summer and winter conditions for each shipping destination. Our challenge was to develop an economical, ergonomic solution that we were confident would protect the product.

Our QA, Validation and Customer Operations staff worked in concert with the vendor’s project team to figure out time, locales, local temperature extremes, distance and other logistical details that would be important in predicting what the shipment would be exposed to throughout its journey.

The vendor designed testing protocols. Once Bayer approved, the company then executed the protocol to test the design, requiring the temperature challenge to be repeated three times for acceptance. Following testing, the shipping vendor drafted an executive summary providing highlights, including the minimum and maximum temperatures achieved during the test.

Each test should have the same outcome; if not, differences should be explainable or resolved. Surprise results needn’t always be cause for concern. For instance, testing may suggest different placement of temperature monitors. Once we approved it, the final report, signed by the vendor, became our official qualification document.

We needed to ensure the solution’s practicality. One key question was what the inner and outer dimensions of the package should be. Among the questions we needed to consider:
  • How well will each solution fit on a standard pallet?

  • Is there enough room for the product to make it worth shipping?

  • How much product will fit inside each desired size option?

  • Is there enough differentiation between size options?
Find a domestic solution

To handle domestic shipments requiring temperatures of 2° to 8°C, we established a partnership with the carrier, Skelton Truck Lines, to design, test and qualify trailers for frozen and refrigerated conditions. Skelton had already introduced some innovations. It was one of the first carriers to link temperature monitors and controls inside the trailer with an in-cab alarm system that notifies drivers of sudden changes in temperature. Temperature data can be downloaded and printed upon request, and the system has a backup unit.

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