Ensuring Shipper Performance

Vendors promote reuse of advanced thermal container systems.

 As manufacturers of pharmaceuticals and biologics focus on ensuring quality in temperature sensitive shipments, they are investigating prospects for containing the costs of distribution and packaging. In offering shipper solutions that promise predictable shipper performance, container vendors are also expanding programs in areas such as reverse logistics and leasing.

An advanced thermal modeling service launched by Cold Chain Technologies (Holliston, MA) supports speed-to-market by taking time and cost out of container testing.
AcuTemp Thermal Systems (Dayton, OH) addresses temperature compliance and waste reduction with its just-launched AcuTemp REPAQ (Reusable Enviro-friendly Program Assuring Quality) reuse service.
After returned boxes are visually inspected, and cleaned in compliance with 21 CFR 211 Subpart 94, the thermal components, tracked by customer and serial number, are retested to original specifications.
“We know that companies have been reusing their passive shipping boxes but without having the most important component and criteria checked—the box’s thermal performance,” says Todd DeVore, director of quality and product development.
AcuTemp’s thermal requalification system uses a proprietary method to test the performance of the passive system insulation. Testing ensures it meets the minimum standards for the box determined through design qualification, says DeVore.
 “This test method has been correlated with actual environmental chamber testing to ensure that a shipper deemed as passing will also pass through the originally qualified ambient profile, such as ISTA 7D or the customer-defined profile,” DeVore adds.
AcuTemp’s box-in-a-bag molded vacuum insulation using its ThermoCor technology minimizes insulation shifting and degradation when compared with standard vacuum insulated boxes, the company says.
The REPAQ program formalizes a return program the firm has had with several customers since late last year. Customers return the boxes to AcuTemp’s Dayton, Ohio campus using a prepaid shipping label and their preferred parcel shipping partner.
The company’s shippers are constructed of 100% recyclable components.
“There has been much talk about the environmentally unfriendly nature of return programs due to the fuel costs associated with returning a box. We are using ground transportation partners that already make large daily deliveries to AcuTemp (so) the only additional cost is the fuel for the weight of the shippers themselves,” DeVore says.
DeVore says that boxes with life time requalification can be requalified and used to a limitless extent. The firm is discussing with partners expanding the REPAQ services in the Eastern and Western United States, Europe, and Asia.
Minnesota Thermal Science (MTS) (Plymouth, MN) offers the Credo Encore solution for reverse logistics support. Encore includes proprietary web-based software and training assistance for clients’ reverse logistics deployment.
Shippers track units through the transport cycle by scanning the unique bar codes on the boxes. The solution supports box inventory management, with automatic triggers when inventory drops below a set level.
Empty containers can be sent back to MTS for cleaning and refurbishment.
Customers can track turns and key-in comments on box maintenance.
“You can track how many turns before the corrugate or vacuum insulation panels (VIPs) need replacing, says Karl Schlenker, vice president of business development, MTS.
Minnesota Thermal Science's Credo Cube line includes sizes from 2L to 96L.
“Reuse of passive packaging systems is a growing priority for pharmaceutical companies. They are focused on reducing their costs as well as environmental impact. Our VIP technology is designed for a 24 to 30 month useful life. The Thermal Isolation Chamber (TIC) system performs for five years before requiring refurbishment,” Schlenker says.
MTS has launched the Credo Leasing Program, partnered with the Minnesota-based Creekridge Capital leasing company. “The Credo Leasing Program is an innovative way to allow people who are cash constrained to get into an innovative technology,” Schlenker says.
Boxes and system components are guaranteed for the term of the lease. A service agreement includes quality assurance inspections and replacement or refurbishment of any component not meeting exacting standards.
Schlenker says the program will be particularly attractive for companies running clinical trials that may lack the resources to buy the containers. “Clinical trials have a limited window to deliver the product for enrolled populations. They can use our Credo containers to minimize the potential for failure and ensure the payload will arrive in spec,” he adds.
“This is a value add for companies with closed-loop distribution of sensitive pharmaceutical, blood, and biologic products. Besides allowing for a lower, monthly fixed payment, leasing provides off balance sheet financing, which converts capital expenditures to a predictable monthly expense,” Schlenker says.
MTS plans to launch in the first quarter of 2010 a pallet shipper with the same thermal components used in the Credo containers. The unit will support refrigerated, frozen, and room temperature storage for a minimum of 96 hours, Schlenker says.
“We are hoping for 120 hours. People are looking for credible high-quality alternatives for shipping pallet size loads. One of the challenges is the complexity of these packouts. Our strategy is to make it relatively simple,” he says.
Cold Chain Technologies (CCT, Holliston, MA) has launched its KoolDesigns service for providing advanced predictive thermal modeling to the pharmaceutical and biotech market. Developed in collaboration with Maya Heat Transfer Technologies LTD, the service is used in the development of new package designs as well as for evaluating existing designs with alternate ambient temperature profiles.
The modeling approach accounts for conduction, convection, phase change, and radiation. “Conduction is properly modeled routinely by applying standard finite element methods. However, properly and accurately simulating phase change and convection are much more complex problems requiring advanced analytical techniques,” CCT said in announcing the service.
KoolDesigns animation of a shipping system temperature profile over an entire summer cycle
“With KoolDesigns, CCT has demonstrated for the first time the capability of using advanced modeling to correctly simulate the full transient temperature response of convective flow-based thermal shipper designs,” says Richard Formato, principal thermal engineer at CCT.
“In the simulation of thermal shippers, a critical component to accuracy is to capture the correct duration of refrigerant phase change,” Formato says.
“For modeling of phase change materials, KoolDesigns uses an enthalpy based formulation for computing the energy balance in control volumes that are changing phase. This is a fundamentally different approach compared to finite element methods,” according to Formato.
Furthermore, the physics of convective heat exchange (between solid and fluid domains) is well characterized by using a coupled thermal/flow solver, which is based on a Finite Difference Control Volume approach. This is another unique feature of KoolDesigns.
The service facilitates speed-to-market by reducing the need for iterative physical testing of the package. Optimal shipper solutions are quickly and accurately developed by variation of insulation material, air pocket geometry, and refrigerant type, size, and placement, Formato says.
KoolDesigns modeling simulates shipper temperature distribution for a winter thermal profile
KoolDesigns also enables quick evaluation of how an existing package design (that has already been qualified against a specific ambient temperature profile) will perform against an alternative profile, such as a profile generated by an updated ambient mapping study or a profile that represents a new shipping lane.
The service can be used to predict how payload temperature will vary due to unanticipated extreme temperatures and extended shipping durations, and also assist to bracket product payload attributes. Specifically, the simulation process establishes limits within which a variety of different payload configurations can be deemed as acceptable for a given that shipper design.
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