Colder Drugs Will Prevail - Pharmaceutical Technology

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Colder Drugs Will Prevail
An expanding number of products and services plug gaps in the cold chain. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 33, Issue 8

"The solution also provides us with a smaller and lighter-weight box, providing advantages in shipping and warehousing," says Alison Becker, director of customer relations and information management for Solstice. The box is also 100% recyclable.


Custom Instapak TempGuard cold-chain packaging can accommodate the exact size and shape of the product and provide pockets for the refrigerant.(IMAGE IS COURTESY OF SEALED AIR)
Although virtually all pharmaceutical manufacturers perform cold-chain testing in house, several suppliers such as Coldpack (San Diego, CA) and AcuTemp operate laboratories certified by the International Safe Transit Association (ISTA). The certified laboratories provide performance data to help narrow choices or confirm in-house test results using ISTA Test Procedure 7D. The thermal-performance test measures the relative ability of a package to protect a product in conditions that simulate the shock and stress encountered during handling and transportation, including both the range and time of exposure to ambient temperatures. If test results look good, the next step is typically real-world testing. Since real-world testing often involves summer and winter trials, the process can easily take a year or more.


The modular Credo Cube surrounds the payload on six sides with panels of phase-change material. (IMAGE IS COURTESY OF MINNESOTA THERMAL SCIENCE)
A package design that protects vaccines in the last mile to point of use has won approval from the World Health Organization (WHO). Cemafroid, the French WHO laboratory, certified the design as compliant with the International Organization for Standardization's 9001:2000 standards for manufacturing isothermal packaging. The insulated packaging combines a thermal barrier with air-cushion protection that has been shown to be four times better than traditional foam insulating panels (AntiFreeze Vaccine Backpack with inflatable AirLiner insulating air cushion, Coldpack). The packaging ships and stores flat, thus saving on freight costs and warehouse storage. An illustration on the package shows how to assemble the unit, and a chart and thermometer help calculate how many ice packs are needed to protect against ambient conditions.


Advice for improving cold-chain protection
The inflatable, insulating air cushion can transform any container into a cooler. The winner of a Gold Achievement Award and Special Citation for Social Responsibility from the Flexible Packaging Association, the air cushion consists of layers of reflective barrier film sealed in a proprietary design. It's available in 22 stock sizes and used by suppliers of vaccines and skin grafts.

Another inflatable package is designed especially for single-dose shipments that must be maintained at 2–8 C (i.e., refrigerated temperature) for 24 h or at 20–25 C (i.e., controlled room temperature) for 48 h (Greenbox Inflator Pack with E23 phase-change materials, Entropy Solutions). The inflatable package is reusable and recyclable and ships for less than half the cost of a traditional single-dose shipper.

"Approximately 15 to 20% of our medications must be kept at room temperature. If they get warmer or cooler, they lose their efficacy," says James Soucey, director of clinical services for Wal-Mart Specialty Pharmacy, an early adopter of the Greenbox Inflator Pack. "Keeping a medication at controlled room temperature during shipment has been mandated by federal and state regulatory commissions for years, but it just wasn't possible given the options on the market," he continues. "Wal-Mart did the very best it could, but now we have an increased level of confidence," he concludes.

For many frozen shipments, dry ice has been the refrigerant of choice. However, it may alter the pH of some drugs, and many carriers consider it a hazardous material because it can cause burns and requires special handling during packing and unpacking. Dry ice also emits carbon dioxide.

A phase-change material was introduced several years ago as a replacement for dry ice in less stringent applications. The US Department of Agriculture lists the material in its Biopreferred purchasing program, and it is now available for frozen products currently shipped with dry ice. The phase-change material can be reused more than 20,000 times, produces no emissions, is 100% renewable and biodegradable, and is 20% lighter than dry ice (PureTemp -40 phase-change material, Entropy Solutions). Amgen (Thousand Oaks, CA) uses it in conjunction with a pallet-size container (Greenbox Pallet Shipper, Entropy Solutions). "We were looking for a solution that addressed the adverse effects of dry ice, while providing a more cost-effective, environmentally friendly option," explains Donnie Wilson, senior manager for engineering at Amgen.

Launched in spring 2009, the pallet shipper features an injection-molded outer container with a built-in 48 40-inch pallet. A modular design makes it easy to replace the phase-change material so the container can maintain a different temperature range.

Another new passive thermal container surrounds the payload on six sides with phase-change material that features precision-formed beveled edges for a tight thermal seal. The modular design is available in five sizes (i.e., 6 6, 9 9, 12 12, 15 15, and 18 18 in.) and supports four temperature levels (i.e., –50, –20, 4, and 22 C) for a minimum of 72 h. The modular design means that sizes can be coupled to create a 9 18-in. container, for example (Credo Cube, MTS).

Significantly lighter than traditional insulated shippers, the container cut tare weight almost in half at one beta test site and doubled payload capacity. "As a result, the new shipper weighs less when fully loaded than the previous shipper weighed empty," reports Schlenker. Lighter weight means lower shipping costs. The container's cube is smaller, too, so more of them fit on a truck or storage shelf.

The container yields additional savings because packout is simpler, and containers and components can be used repeatedly and then recycled. In a two-year trial, 1500 shippers completed 10,000 trips with no losses resulting from temperature excursions and kept at least 8500 one-way shippers out of the landfill.

Frozen products previously shipped with dry ice benefit even more. Eliminating the dry ice not only results in a smaller, lighter package, but also eliminates handling concerns and the charge that carriers add to the freight bill for dry-ice shipments.

Phase-change material and gel packs are conditioned before use, a step that requires time and energy for chilling or freezing. Protective packaging that eliminates conditioning provides cooling by evaporating water under vacuum. Once switched on, it takes less than 5 min to operate at full efficiency. To indicate that the unit is working, a label printed with thermachromic ink turns blue as the temperature cools. The cooling system is designed for one-time use, but the insulated shipper it fits into can make multiple trips (NanoCool protective packaging, NanoCool, Albuquerque, NM).

Although most developments in cold-chain packaging focus on conductive systems, new high-performance convection systems are worth considering. One relies on polyurethane-foam insulation to keep shipments cold longer than would be possible with polystyrene foam. This higher insulation factor reduces the amount of dry ice or gel packs needed to protect the payload and may allow shippers to switch from overnight delivery to more economical two- or three-day service. High durability means the foam insulation can be reused (Instapak TempGuard Cold Chain Packaging, Sealed Air, Danbury, CT).


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