Tracking Cold- Chain Quality
Pharma firms focus on logistics, as new shipper solutions extend cargo protection.
Minnesota Thermal Science combines its Thermal Isolation Chamber (TIC) system with vacuum insulation panels (VIPs) for temperature sensitive shipments.
As pharmaceutical companies devote more attention to cold-chain logistics, transport product and solutions providers are stepping up specialized services to support safe product delivery and limit costs.
Regulatory and best practice guidance will support quality and cost control as supply-chain partners work in concert to establish that product is appropriately handled, stored and transported, says Larry Gordon, president, Cold Chain Technologies (CCT; Holliston, MA).
“As quality-driven guidance written by industry members, PDA’s Technical Report 39 is extending direction on GMP to good distribution practices. The goal of both USP Chapter <1079> and TR 39 is to help drive the regulations and guidance from paper to practice, ultimately increasing compliance through quality systems that support receipt, storage, packaging, transport, and delivery of temperature-sensitive goods,” Gordon says.
“Everyone in the distribution process has to step up and pay more attention to meeting specific quality goals as part of their business operation,” Gordon adds.
CCT is working with some clients on supply-channel logistics. “For taking costs out of cold-chain shipping, you need to understand the whole chain from manufacturer to end-user,” says Bob Bohne, vice president and general manager, CCT. “You may want to eliminate carriers or reconfigure lanes to cut down on shipping times and better manage temperatures.”
For some customers, CCT is developing packaging that is used to profile lane temperatures based on measured field data. “When we can understand the actual shipping profiles, we might be able to take a 72-hour box down to a 48-hour box, or use less expensive materials,” says Bohne.
“Customers vary in how they select their profiles. Some fall back on ISTA profiles. We rigorously define a profile that will protect a high percentage of shipments, while minimizing the packaging costs,” he adds.
Sentry Logistic Solutions (Indianapolis) draws on its knowledge of shipping-lane characteristics and carrier alternatives in developing shipper solutions for customers. The 3PL (third-party logistics service) is fixing data monitors on shipments to collect data on ambient temperatures, says Eric Isom, manager of warehouse operations.
“We are just starting to monitor containers to develop ambient profiles. With one client shipping by ground and air we are jointly assuming the costs of monitoring every container we ship out,” Isom says. “So we can tell them what the testing profile should be. You are reducing the cost of six to nine months of package testing.”
“Over the long term, it is better to collect your own data. If you have a defined profile for a defined lane and you know how the packaging performs, you can reduce the packaging or increase the packaging to reduce your loss,” he says.
“It is a continual process. Often we find that customers fail to realize that carriers’ processes change and therefore temperatures change,” Isom adds.
Beside temperature mapping for select lanes, CCT also works with customers to “forecast packaging using multiple carrier solutions,” says Gordon. “Products are packed out with destination weather in mind. “Instead of one-size-fits-all, we are qualifiying packouts based on weather patterns for destination lanes. With this approach, packouts are more efficient and less costly, but need to be balanced with inventory package supply levels and system capabilities.”
“In all cases, we are asking what the customer’s needs are,” Gordon says. “The predominant influencing factors are the temperature range at which the product needs to be maintained, and for what duration. These requirements dictate how much leeway we have in reducing packaging costs, and the resulting freight costs.”
“If a U.S. manufacturer allows us to develop packaging to their stability data [allowing for temperature excursions], we can usually develop a package with less material and lower shipping costs. A packout for 2° to 8°C will be more elaborate and costly than one for 1° to 10°C,” he adds.
Sentry provides storage, packaging, and logistics services to large and small shippers of drug materials and products. Smaller firms often look to the 3PL for a complete transport solution.
“We have found we are getting more interest from larger pharma companies that are moving to outsourcing the back-end storage and shipment to the end-user,” Isom says. “Virtual companies and smaller bio-drug firms often have little experience or knowledge of how to maintain transport temperature for raw material and finished product. We assess the carriers, and lanes, and give them multiple carrier options based on cost, without bias.”
Sentry might advise standard overnight shipping for a product that is stable at room temperature and can handle excursions. “Or we can show a customer with product that is not able to handle excursions how they can use priority overnight, increase control of the product, and thereby reduce the risk of loss and potentially save money,” Isom says.
Newer shipper solutions promise cost-effective shipping for longer durations. Minnesota Thermal Science (MTS; Plymouth, MN) has launched new solutions for payloads requiring refrigerated and frozen shipment, in rebranding its shipper systems as the Credo line.
MTS shippers protect product over extended periods, feature high payload efficiency, and minimize package weight. PCMs are held in a Thermal Isolation Chamber (TIC) system that is typically coupled with vacuum insulation panels (VIPs).
In the line of Series 4 shippers using 4°C PCMs, the new Credo 4-2168 keeps product within 2° to 8°C, or 1° to 10°C, for seven days. VIPs feature a Mylar wrap over a silver liner to add performance and make the panels less vulnerable to puncture. VIPs used in Credo systems stand up to two years of use if they are not abused, says Karl Schlenker, vice president, sales.
“The Credo 4-2168 is the longest duration passive thermal shipper available,” Schlenker says. “We call it an international shipper because even if it is held up in customs, the payload will arrive in spec. For ground freight, you can go next-day shipping without a refrigerated truck, so the cost-savings are substantial.”
The unit features a box-in-box design, with one set of VIPs surrounding the TIC. A second set surrounds a second card box inside the TIC. The 2-l volume TIC in the 4-2168 “continuously deflects the BTUs as they penetrate,” Schlenker notes.
For frozen-temperature shipments, the Credo Series 50M avoids the need for dry ice or liquid nitrogen canisters. The TIC and VIP-configured shipper holds –50°C temperatures for up to three days, with 17 L of payload space. Temperatures of –18° or colder are held for up to a week, Schlenker says.
MTS features design consulting and prototyping services that include validating shippers to ISTA test procedures in an ISTA-certified lab. The company developed a system for LifeCell (Branchburg, NJ), a tissue-processing and -recovery company, that uses a TIC with a custom PCM for 0° to 10°C shipping. Custom insulation was used to address the customer’s concerns about potential VIP leakage.
“LifeCell came to us with its own set of test protocols. It needed assurance of performance in extreme hot and cold temperatures. It was using a corrugated box with 20 lb of wet ice in a plastic bag. Carriers were experiencing ruptured containers,” Schlenker says.
MTS manages LifeCell’s container inventory, receiving pallets of empty boxes in Plymouth for inspection, sterilization, and reuse. MTS also manages the box inventory at the company’s tissue recovery centers around the country. The LifeCell Shipper has enabled LifeCell to reduce costs by shipping the 25–40-lb tissue cargos for next-day delivery, Schlenker says.
Entropy Solutions (Minneapolis) has launched the Inflator Pack for shipping small quantities and single doses. The packaging maintains controlled room temperature (CRT) for 24 to 48 hours, as well as refrigerated temperatures (2° to 8°C) for one to two days.
“Packaging companies have struggled to devise solutions for maintaining consistent CRT, and there seems to be a broad definition as to what CRT is,” says Eric Lindquist, president.
“Presently, CRT is defined in Europe as 15° to 25°C, and 20° to 25°C here in the United States. This is getting a lot of attention now in the work being done by the USP and PDA,” Lindquist adds. (USP defines CRT as 20° to 25°C with allowable excursions of between 15° and 30°C and transient spikes of up to 40°C for short durations.)
Entropy’s system can maintain CRT in a narrow range. “We have the only sustainable technology that can hold a tight temperature window of 20° to 25°C,” Lindquist says. “In developing the Inflator Pack, we did development work with Wal-Mart to make sure that high-value drugs it ships would stay protected.” Wal-Mart has begun using the Inflator Pack for CRT and refrigerated shipments of medications to patients’ homes. The Inflator Pack features bladders of compressed recycled foam welded to the inside of a 19 × 1l or 12 × 14 × 2-in. outer envelope. Air expands the bladders when the package is punctured at designated points, creating inflated cushions for shock and vibration protection.
The system features the same dual-PCM configuration used in the company’s Greenbox, but uses soft-sided, five-chamber pillow packs rather than E-Packs. The patent-pending pillow pack design helps surround the cargo with the PCM. Wal-Mart is also piloting Entropy’s Greenbox shippers for CRT and refrigerated shipments to Alaska, Hawaii, and Puerto Rico, where the chain encountered excessively high spoilage from shipment durations and ambient temperatures.
Two PCMs with different phase points simultaneously absorb and release heat, providing a “thermostat” effect that keeps Greenbox temperatures in desired windows for five-plus days.
Lindquist says the Inflator Pack’s smaller size and lighter weight compared with standard styrofoam and gel pack systems allows shipment cost savings. The pack weighs 1.9 lb versus 4–8 lb for a traditional packout.
The pack comes with a double-seal for resealing the pack after removing the drug, and preprinted return labels for sending the used packaging back to Entropy or to the customer.
“People are finding our reclamation process extremely interesting. As with the Greenbox, the Inflator Pack (PCM) panels are reusable, and the package is recyclable,” Lindquist says.
Entropy is expanding distribution to markets in Europe, Australia, New Zealand, and Singapore with a partnership with SCA Cool Logistics, SCA Packaging Group (UK). SCA will manufacture and distribute the Greenbox and other Entropy products. “We will license certain components of our technology, which SCA will manufacture locally to our quality standards,” says Lindquist.
AcuTemp Thermal Systems (Dayton, OH) and AmSafe Inc. (Phoenix) have formed a joint venture for providing solutions for the perishable airfreight market. CSafe LLC, a separate operating company, will manufacture and market air-cargo temperature-management systems to airlines and pharma companies.
AmSafe was marketing the AcuTemp RKN to the air-cargo market, while AcuTemp was focused on the pharmaceutical and biotech market.
“CSafe brings together the key competencies of the two companies for serving the cold-chain and air-cargo markets. The new company will be a single source focusing on these two markets,” says Brian Kohr, general manager of CSafe.
With manufacturing locations in Ohio and Washington state, CSafe will license thermal technology from AcuTemp and then manufacture and sell the systems.
“CSafe will provide a center of excellence for firms looking for pallet shipper solutions for the 2° to 8°C segment,” Kohr adds.
CSafe’s flagship product, the AcuTemp RKN, is the only FAA-approved active container for use in aircrafts’ lower-deck cargo sections. The unit maintains temperatures in the 4° to 25°C range, with a plus-or-minus tolerance of two degrees.
FedEx first adopted the RKN in an exclusive use agreement. The shipper is now available for sale or lease to pharma firms, airlines, and logistics providers.
“The AcuTemp RKN is a performance solution and a risk management tool. Products can be loaded without any additional protective packaging often required with other pallet shippers, so more product can be shipped. You simply load it, lock it, and ship it,” he adds.