Fisher BioServices Adopts Credo Container for Flu Vaccines
By David Vaczek
As a provider of logistics, laboratory, and repository services for clinical trials, Thermo Fisher Scientific’s Fisher BioServices (Rockville, MD) ships temperature-sensitive drugs, patient specimens, collection and shipping kits, and bulk supplies to sites around the world. The contract services business stores more than 120 million samples including blood, urine, tissue, environmental, and active pharmaceutical ingredients.
When transporting samples and kitting supplies, Fisher BioServices must ensure that payloads arrive at clinical sites, laboratories, and repository depots in an efficacious manner, says Bruce Simpson, senior director, commercial services division operations, Fisher BioServices.
Fisher BioServices recently adopted containers from Minnesota Thermal Science (MTS; Plymouth, MN) for temperature- sensitive domestic shipments supporting a clinical trial. Simpson says Fisher plans to expand its use of MTS cold-chain shippers for payload protection over international routes.
Fisher BioServices initiated a relationship with MTS when it was looking for a better cold-chain solution to gain a competitive advantage in the marketplace. Fisher extensively evaluated MTS’s shipping containers. Validated under various ambient conditions and profiles, the shippers’ performance stood out when compared with packouts using commercially available boxes and insulation, Simpson says.
Fisher was using cardboard containers with expanded polystyrene and gel packs, or dry ice for –60° to 80° F, and dry cryogenic shippers with liquid nitrogen.
“Our engineers found that MTS’s boxes were far superior to the conventional packouts they were testing. If the thermal isolation chambers [TIC] containing phase-change material [PCM] are appropriately tempered, and the package is packed out as designed, the performance is exceptional,” he says. Testing showed that the shippers maintained the appropriate internal temperature range for seven days or more.
For Fisher’s first commercial application, MTS engineers calculated the mass of material required in the box to hold the required temperature, after Fisher provided shipping duration, payload, and temperature requirements.
Fisher began using the MTS Credo 4-1772 4° container for shipping flu vaccines to U.S. locations, as part of an international clinical trial.
Simpson says the containers offer several advantages over traditional shippers. The packout is much simpler. Traditional solutions require staging two or three different types of gel packs, and packing them out with foam insert configurations. “With the MTS, you pop in the TIC and the packaging material [such as bubble wrap],” he notes. “The solution will be as effective as employees are in following the directions. If you don’t pack it out the way it was validated, you will have no assurance of efficacy.”
Minimum time and temperatures are required in TIC conditioning.
“Typically the TIC has to be tempered for 24 hours to reach temperature. For a 4° shipment, you put the unit in a –20° freezer for a minimum of 24 hours. Then bring it out to ambient for a half-hour rest period.”
The shippers have proven to be durable, withstanding repeated use in the flu vaccine clinical trial shipments to Pennsylvania, California, and Washington.
“We have used the same shipper five times. We get them back empty, peel off the outer labels, and outer corrugate if it’s damaged, refrigerate the PCM for 24 hours, and use it again,” he says. Simpson says another advantage is the containers are more sustainable than systems using gel packs, dry ice, and foam.
A limitation of the MTS container is that it isn’t cost-effective unless clients return them, Simpson says. Fisher pays for the return shipping, but that adds to the client’s contracted cost.
“Operationally, my biggest concern is getting all the components returned,” he says. “We explain to the client what we are doing and why. If they don’t want to send the container back, we will use a traditional pack out. However, we believe that for many clients shipping hundreds of thousands of dollars worth of product, the added expense will not be an issue.”
Fisher BioServices plans to adopt MTS solutions for payloads requiring cold and frozen temperatures, as it expands use of the containers on global routes. The containers’ long-duration performance will allow more choices in shipping alternatives and carriers, and will address concerns over lack of performance in Third World countries.
“If we are shipping from Johannesburg to Ghana, there is one flight a day,” Simpson says. “If you miss it, you wait for the next one. In Ghana, you have to clear customs, then travel 400 miles by truck on bad roads. If there is no system set up for replenishment of the gel packs, dry ice, or liquid nitrogen, you might lose the valuable sample or product.”
For ensuring products’ safe transport, Fisher cross-docks when possible at Fisher depots where containers can be recharged with the appropriate medium. Fisher also relies on logistics providers for reconditioning services, including World Courier and Priority Solutions International. Priority Solutions was acquired in 2007 by ThermoFisher Scientific and integrated into the Biopharma Services Division. “[But] these services come with fees associated with recharging in route,” he says. “With the MTS, we may be able to avoid these charges. More countries have refrigeration or freezer capacity, if not the ability to make dry ice or liquid nitrogen. Using the MTS containers, we see the potential to use different transport lanes and carriers than we have in the past.”
“Fisher BioServices’ experience demonstrates the MTS shipper is a superior cold chain temperature shipping solution that guarantees the samples will get there in an efficacious manner, and with less or no failure points when they are prepared and assembled appropriately,” Simpson says.