Bayer Warms Up to Cold Chain Supply

We developed a protocol, which was executed by our Validation department, to qualify their trailers for dedicated < -20°C use. We performed these tests on-site at our facility. Once completed and approved, and prior to using the trailers, Skelton developed additional SOPs that adhered to our existing SOPs for transportation and the handling of plasma products. Finally, we completed a vendor and operational audit of Skelton’s operation.

Both Bayer and Skelton were also interested in qualifying the trailers for 2° to 8°C service, so we shared development resources. Skelton worked with our QA, Validation and Customer Operations staff to set logistics and validation parameters. The company contracted a third-party validation firm to qualify the trailers for 2° to 8°C, and developed a testing protocol with that firm. Our experts provided technical advice and approved the final test protocol. Skelton then approached other customers to share in the development costs. The end result was the qualification of their entire fleet. Skelton retains ownership of the qualification of the trailers to benefit their offered services.

Once qualification was complete, summary reports were provided to us for review and internal approval. We incorporated the reports as supporting documents within SOPs for shipment of product procedures. Skelton provides exclusive-use trailers for transport of our biological products. Now that we have a great deal of shipments and data, we are retrospectively reviewing this temperature data to ensure compliance and continuous improvement.

Find a global shipping solution

For global shipments, we collaborated with Envirotainer (Knistva, Sweden), a specialist in active temperature-controlled air transportation solutions. Working with Bayer’s QA, Validation and customer operations staff, Envirotainer established logistics parameters and assigned staff to help us design a secondary packaging system. The team also developed procedures to ensure product stability throughout the shipping process. We shared development resources and Envirotainer used our discoveries to further develop a specialized business unit: Cold Chain Management Service.

Envirotainer collaborated with us to develop trial runs that would lead to a shipping process for actual product. The shipping trial included evaluating logistics parameters, conducting collaborative meetings with the shipper, forwarder and airline, and pre-conditioning the container to +5°C. The next steps included writing container-loading procedures, determining the best locations to place temperature monitors, creating summary reports, and co-developing preliminary shipping guidelines.

In the early stages of development, we worked with Envirotainer to create engineering tests and trial runs for our targeted primary shipping lanes. We visited the San Francisco, Atlanta, and Philadelphia airports and met with freight forwarders and airlines to map out process and responsibilities. After about four months, Bayer and Envirotainer jointly developed the “I-box” solution for shipping product at 2° to 8°C in ambient conditions outside the standard Envirotainer specifications.

Creating testing protocols

Creating testing protocols means first selecting an ambient profile and the transit time needed for the longest anticipated shipping routes. Your process should mimic actual events. Walk through the entire shipping process – don’t forget to involve your shipping team in this process.

Keep in mind the geography of your shipping regions and their respective seasons. A testing protocol should include, but not be limited to the following:

• introduction and purpose
• test duration
• equipment to be used
• where and how the test will be administered
• number of repeat tests
• procedures to be followed and who will execute each procedure
• thermocouple placement
• expected outcome.

To arrive at our current 2° to 8°C solution, we used a number of TempTales, temperature measurement devices developed by Sensitech, Inc., to monitor the inside temperature of the container. In this case, we have incorporated the I-box solution, recommended by Envirotainer, to meet our requirements. The Envirotainer is designed to hold 2° to 8°C during 72 hours when ambient temperature is more than 5°C and less than 25°C higher than the temperature of the shipped product. Our ambient range was wider. Essentially, we have an insulated box inside the Envirotainer that helps to stabilize temperature fluctuations during shipment.

We found that it was extremely important to monitor the outside, or ambient, temperatures during shipment. This exercise helps us determine how well our planning has been executed, and provides additional data for future improvements.

The components of the I-box are first pre-chilled in our +5°C warehouse. The skid is then assembled inside the warehouse, complete with temperature monitors, and loaded into the Envirotainer. Shipments using the I-box solution have provided excellent flatline results in the 2° to 8°C range, even in conditions outside the Envirotainer container specifications. We currently use two sizes of Envirotainers for shipments in the 2° to 25°C range. No additional packaging material is required for these shipments.

As a cold-chain management service, Envirotainer helped us create a shipment summary report. This report allows us to strengthen our relations with service/transportation providers and recommend improvements. It also defines base guidelines for handling cold-chain products and identifying any temperature deviations and pinpoint problem areas.

Creating and implementing shipping guidelines

Once the solution was designed, we needed to create the procedure document that would show how to ship the product. This document should include comprehensive details about:

• pre-chilling of containers or ambient start (how many, when, who
• staging
• temperature monitor placement
• monitor checklist
• diagram and container sealing details.

A good procedural document should be concise yet thorough, easy to read and free of jargon. The document should identify actions required throughout the shipping process, and determine who is responsible for each one.

As we implemented the solution, we found that adhering to and qualifying the cold-chain process that had been written was often challenging, since many commercial shipping vendors are not accustomed to the levels of regulation that drug manufacturers must comply with. For international shipments, we worked exclusively with Uti, an international freight forwarder. UTi acted as a broker and logistics facilitator to make sure the shipping was handled efficiently and according to guidelines. Our excellent relationship with UTi has allowed us to ship with piece of mind, due to their attention to our needs and adherence to our process and procedures.

When developing a cold-chain shipping solution, there are many aspects to consider. Close collaboration and good working relationships are critical to any successful solution. Other important elements include the qualification of solutions, creation of testing protocols, and placement of temperature monitors. The final step is to utilize your vendors’ insight, experience and resources as completely as possible to establish and implement shipping.

With patience and resolve, and vendors you can trust, your shipping solution will turn out much better than Mr. Martin’s and Mr. Candy’s ill-fated journey.

About the Author
Jim Bacon is director of global supply chain for Bayer Healthcare — Biological Products Division. He is responsible for the allocation and movement of all the division’s products, from manufacturing sites to Bayer regional and third-party affiliates worldwide.