New technologies

Innovation is leading to better insulation products, the ability to maintain a specific temperature range for longer time periods, and in-transit monitoring that doesn't require the package to be opened, thereby lessening the risk of counterfeiting and diversion. Pharmaceutical packagers rely on a host of tools to maintain products at the proper temperature. Options include phase-change materials (PCMs), insulating materials, environmental data loggers, software for monitoring and tracking shipment conditions, three-dimensional modeling software to optimize package design, integration of temperature protection/monitoring by logistics providers, and temperature-controlled bulk containers to protect larger shipments.

Phase-change materials. Shippers combining vacuum-insulated panels with refrigerants based on PCMs have captured market share from traditional expanded polystyrene (EPS) and polyurethane (PUR) structures and gel packs or dry ice (2). The PCMs liquefy or solidify (freeze) at specific temperatures and recharge as ambient temperatures fluctuate. PCMs are typically preconditioned in a freezer or refrigerator before use, protect longer than gel packs, and eliminate the replenishment requirements and off-gassing hazards associated with dry ice. In addition, a single PCM unit typically replaces multiple gel packs, thereby reducing the size and weight of the transport container.

Data loggers record conditions the shipment experiences and can quickly indicate if a problem occurred. In some cases, units can deliver a proactive alert so that action can be taken to protect the shipment before the product becomes unusable.

Ease-of-use is maximized by features such as an onboard USB connection. "When plugged in, the logger provides PDF data files," explains Rich Ellinger, vice-president, life sciences at PakSense, the maker of a label-like data logger (BIOmed XpressPDF Temperature Monitoring Label). "No additional infrastructure is needed," says Ellinger.

Radio-frequency Identification. With wireless technology, a container does not even have to be opened to access temperature data. Keeping the shipper closed not only helps maintain the environment around the payload, but also means, "there's no need to change supply-chain practices to collect information," explains Kevin Payne, senior director of marketing at Intelleflex, a provider of radio-frequency identification (RFID) tags and related software for temperature monitoring.

Data can be read or written to a Class 3 battery-assisted passive RFID tag at distances up to 300 feet. This stronger penetration power allows readability through ice and insulation, for example (TMT-8500 temperature monitoring tag, Intelleflex). The credit-card-size tag, which measures approximately 0.25-inch thick, will gain functionality in 2013 with the addition of humidity and light-monitoring features. "Light monitoring is important because recipients can tell if the box has been opened during its travels," explains Payne.

Interest in RFID-based monitors is increasing, according to Tom Dolan, director of sales at RURO, a supplier of turnkey RFID systems. Because hundreds or even thousands of RFID tags can be scanned at the same time, the technology offers potential for high-speed automated data collection not possible with traditional barcodes. In addition, Dolan says, RFID "costs have come down, and there are more vendors in the market." Furthermore, performance improvements allow RFID tags to work reliably despite metal interference and other challenging conditions like cryo environments.

A reusable, credit-card-size tag relies on ultra-high-frequency (UHF) RFID, a five-year battery, and a tactile button to monitor temperatures from -30 to 55 °C within +/- 0.2 °C . An onboard microprocessor enables a variety of calculations, including remaining shelf life, mean kinetic temperature, and multiparameter alarms. Custom product configurations are written to each tag and easily updated in the field. Pressing the button turns the unit on, checks for compliance with preset parameters, or records the temperature at that moment. When the button is pressed, if the light-emitting diode (LED) on the tag blinks red, a temperature excursion has occurred. If the LED blinks green, programmed parameters have been met. Tags are read with a handheld or stationary reader and deliver data instantly to a CFR 21 Part 11-compliant, web-based data system. A single click identifies exceptions that may need immediate attention, and all data are archived for review and analysis. The tag, which can log thousands of time/temperature points while affixed to a package, case, or pallet, can be read and restarted at any time to record new segments, owners, or temperature parameters (UHF RFID tag and web-based monitoring system, TempTRIP).

Data access. To be actionable, temperature data must be accessible. A cloud-based data-sharing application provides access to anyone (with clearance) anywhere so timely decisions can be made about a shipment. For example, if an excursion occurs, an alert can provide instructions to move the package into the proper environment (ZEST Data Services, Intelleflex).

A provider of intelligent, reusable transport packaging relies on this data-sharing application to provide real-time alerts about potentially damaging deviations from required environmental parameters (Supply Chain Technology Solutions, Rehrig Pacific). According to Kaley Parkinson, technology sales manager at Rehrig Pacific, this high level of visibility economically addresses the industry's need for better in-transit monitoring. In fact, he predicts that future systems will integrate "with a broader range of existing systems that will streamline and simplify the transfer of information across various platforms for all...users."

Cold-chain services. Cold-chain management has become an important business for logistics providers. In fact, many airlines, parcel delivery services, and common carriers run dedicated cold-chain operations that offer high levels of environmental control and shipment visibility.

Clinical-trial specialists also are firmly focused on cold-chain services. One global supplier has expanded its cold-chain storage and distribution capacity in Pennsylvania, the UK, and Germany to maintain frozen and refrigerated products at the proper temperature (Clinical Supply Services, Catalent Pharma Solutions). "The steadily increasing number of biological products in development, particularly in prefilled syringes, is fueling the need for refrigerated storage and distribution," explains Frank Lis, vice-president and general manager of clinical supply services for Catalent Pharma Solutions.

Almac, another clinical-supplies specialist, has added refrigerated labeling facilities in the UK, thereby minimizing product exposure to temperatures outside the 2–8 °C range. The capability is mirrored at the company's US headquarters in Pennsylvania. The Northern Ireland-based firm also offers a smaller, lighter cold-chain shipper along with a temperature monitoring system (refrigerated storage/labeling areas, temperature-controlled shippers, Shipping Temperature Electronic Monitoring System, Supply Chain Management team, Almac Group). Sharon Courtney, head of distribution at Almac, reports, "In the first six months since implementation, the shippers achieved an impressive, less than 0.33% excursion rate across the board."