Temperature and Moisture Control
Tom Pringle, technical director of ISC Labs, SCAThermoSafe (Phoenix), says that FDA is paying close attention to insulated shipping systems and transportation packaging for protecting pharmaceuticals and medical devices from temperature-related damage. "FDA field inspectors increasingly want backup data explaining how ambient temperature profiles were developed for use in simulated shipping studies for thermal packaging qualification," Pringle says.
Several firms, like ISC Labs, Cold Chain Laboratories, DDL Inc., and others, can help packagers amass this data, either through field or laboratory testing. And recent product developments may help you achieve temperature protection.
Packaging. Advantek (Minnetonka, MN) offers Vaculok Vacuum Insulation Panels (VIPs) that offer R-values up to 30. VIP components include a core material, a metal foil or metallized barrier film, desiccants, and getters. The core is evacuated to a level of <0.05 torr. and sealed in the barrier film. Desiccants or getters are sealed within the panel to adsorb any remaining moisture or gas molecules.
Tuscarora/SCAThermaSafe's Division (Wheeling, IL) offers molded, expanded polystyrene (EPS) foam for efficient, cost-effective temperature maintenance. Marketed under the name Thermosafe, these thick-walled containers maintain temperatures through an insulating K factor of 0.19. The firm says independent tests show that the rate of dry-ice sublimation from these units was approximately 3 lb per 24 hours. The firm offers stock styles and sizes and designs containers for specific needs. Also, its Deep Chill Shipper combines VIPs and EPS, holding contents below 10 degrees C for more than 96 hours without dry ice.
Cold Chain Laboratories' (Holliston, MA) insulated shipping containers, called Cold Chain Solutions, are now available in popular off-the-shelf sizes. Company president Larry Gordon reports that the containers, made of either expanded or molded polystyrene or molded polyurethane, are available in three temperature controls of 2°-8°, 2°-15°, and 2°-25°C. The firm recently moved to expand its testing chambers to nine to help users qualify packaging.
Control. Tech Pak Solutions Inc. (Peabody, MA) just introduced the Guardian PCM4C phase-change material for keeping products at temperatures between 2° and 8°C. Designed to phase at 4°C, the PCM4C is designed to act as both a heat shield and a heat sink.
Monitoring. Pringle says that many packagers are using externally mounted battery-powered trip monitors to collect ambient temperature data. "Many reliable monitors are available for collecting ambient temperatures, along with other data like shock and vibration," he says.
Veriteq (Richmond, BC, Canada) recently introduced its Very Low Temperature Logger (VL-1000-VLT) for shipping products at temperatures as low as -86°C. It features a soldered battery connection and a five-year battery life. The firm's software helps users comply with 21 CFR Part 11, allowing them to print reports and graphs.
Moisture Control. Another hazard threatening packages during transportation is moisture, says David Payne, senior product development specialist for Multisorb Technologies Inc. (Buffalo, NY). Condensation collecting in a freight container can "alter packages made of paper, affecting appearance and strength," says Payne. For example, when exposed to 80% humidity, a corrugated container can lose 50% of its strength, becoming vulnerable to physical hazards. To combat moisture,
Multisorb introduced TranSorb, a mineral-based desiccant packaged in a Tyvek/film structure for use in freight containers. It adsorbs and retains moisture gradually for up to 45 days at most temperatures, which Payne says is slightly longer than some competing products can. TranSorb stabilizes the adsorbed moisture and keeps it from leaking.