Schering-Plough upgrades clinical trial distribution

With a new approach using Credo shippers and Elpro data loggers, a company reduces excursion rates and costs.

After completing an assessment of shipping technologies and supply chain practices, Schering-Plough (S-P) has adopted new container and data-monitoring solutions for clinical supply distribution.

S-P is introducing Credo shippers from Minnesota Thermal Science (MTS; Plymouth, MN) to all S-P subsidiaries globally for the transport of clinical trial products. Also, the company has implemented the Libero PDF data logger from Elpro-Buchs AG (Switzerland) to enhance its cold-chain data logging capabilities.

S-P engineers reported on the company’s evaluation of the technologies at the recent IQPC 7th Cold Chain Distribution for Pharmaceuticals conference in a presentation titled “A New Paradigm in Clinical Supplies Distribution.”

S-P clinical shipments for human drugs, animal health, and consumer healthcare products involve 5000 clinical sites worldwide. According to S-P engineers, meeting the target to support the patient is paramount—and the main difference between in–time product delivery during clinical trials versus making a finished product available through commercial distribution.

“The key to successfully maintaining temperatures of the material during transport is to incorporate robust monitoring and containment technology and to devise a plan to mitigate the risk associated with material movement during each hand off in the shipment,” presenters said.

Early efforts that involved using EPS containers and chemical indicators configured to product storage temperatures were not cost-effective. Shipments experienced temperature excursions of 40%.

When evaluating containers, S-P considered a list of factors including user friendliness in shipper preparation and receipt, time required for conditioning, the number of PCMs used, and ease of pack out. Containers were judged on space needs, the weight of the insulating technology, and their durability and opportunity for reuse. All systems had to be pre-tested to multiple thermal and transit conditions.

“Credo 4C and room temperature shippers undergo four thermal tests and an ISTA drop test for certification,” said Karl Schlenker, vice president of business development, MTS.

“Units are tested to ISTA summer and winter profiles, and at constant 40°C and minus 20°C for 60 hours or longer.”

S-P concluded that the solution should use a single PCM system and VIPS and support reuse.

The Credo GH17 container for 4°C shipments was tested in a pilot with several S-P distribution depots.

“Credo provided a robust system in the 17-liter 4°C application with no need for customization,” presenters said.

The S-P engineers said an advantage of the system is that the added size and weight of a buffered gel pack system is avoided. The payload is completely surrounded by PCM, which reduces interior temperature fluctuations for better payload protection. The payload can be in direct contact with the PCM panels without the use of tertiary containers encasing the product, thus increasing product load volume. A single PCM means one conditioning environment and a locked-in temperature phase.

VIPS provide higher insulation per unit weight at higher volumetric capacity. The ability to clean and reuse the Credo system’s thermal isolation chamber (TIC) panels was demonstrated in a reverse logistics pilot. The pilot showed that far fewer containers had to be used and inventoried with an 84% average shipper return rate.

S-P found advantages in reduction in costs and excursions—the smaller weight and size of the containers, the use of standard delivery and increased payload all reduced costs. A universal packout addresses packaging time and errors. Labor savings accrue from less training time, simple pack out, and less time to condition.

S-P chose the Libero data logger to support the programming of product stability data. In addition, the units can be configured with event parameters and alarms based on cumulative alarm time and temperatures across multiple time/temperature ranges.

Using product stability data, false positives were reduced to nearly zero. “With integration of stability data into the device, you can disposition quickly during an alarm event and know if replacement product is required,” presenters said.

“If the alarm occurs, you replace the product and do not have to wait for the logger return for reading.”

The Libero plugs into a USB interface of a PC for automatically generating PDF files of the raw shipment data, allowing elimination of equipment at destination points.

Excursion rates were reduced from 12% to under 2% during testing of alternative shippers using Libero loggers with programmed stability data.

According to the presenters, the Credo units reduced, or in some cases eliminated, lost product due to temperature excursions. The units can be put in a cold environment for extended periods without driving the temperature below the lower storage limit of 2°

“The excursions they experienced were due to excessive periods when product was held in customs, or due to user error (in packout or storage),” says Schlenker. “They found if they requested refrigeration for boxes held in storage for extended periods, they never lost any material. The PCM was reconditioned, which extended it performance.”