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

Condition monitors

Data loggers have long been used to monitor shipment conditions. In recent years, these devices have been supplemented by thermochromic labels, radiofrequency identification (RFID) tags, and electronic sensors that can be read through cell phones and global positioning systems.

New features on traditional data loggers include the ability to generate reports in PDF format within the unit, thus eliminating the need to install and qualify separate software. The user simply plugs the unit into the USB port on a personal computer to download the report (Libero cold chain monitor, Elpro, Marietta, OH).

A new family of devices monitors variations of 1 F for temperatures ranging from –15 to 50 F, tracks temperatures for days or as long as two years, collects temperature data at intervals ranging from 2 s to 9 h, and provides a history of how long the product experienced temperatures outside the recommended range. (Cold chain sensors, readers, software, and support, Cortegra, Fairfield, NJ).

A battery-powered RFID tag operates at ultrahigh frequency (868–960 MHz) and measures temperatures between –30 and 85 C with 0.5 accuracy between –5 and 15 C and with 1 C accuracy below –5 and above 15 C. Other features include memory that stores 4096 readings, an integrated clock, and two-year battery (RF Thermochron sensor, Maxim Integrated Products, Dallas).

Cold-chain logistics

To prevent gaps in the pharmaceutical cold chain, many logistics providers offer specialized services. One joint venture supplies a compressor-driven refrigeration unit designed for air transport. It can heat or cool to maintain user-selected temperatures between 4 and 25 C at ambient temperatures ranging from –30 to 50 C. The container can maintain a constant temperature more than four times longer than dry-ice-based systems and sustain a controlled temperature environment for as long as 100 h. The system also records payload, temperature, access, and power status. This information can be downloaded through a USB port (AcuTemp RKN cargo container, CSafe, Dayton, OH, joint venture between AmSafe, Phoenix, AZ, and AcuTemp).

An airline offering cold-chain services provides priority handling and a coordinated shipment process with multiple checkpoints throughout the journey. Other components of the program include cool-room facilities, dry-ice-based containers and thermostat-controlled containers equipped with heating and air-conditioning units to maintain an interior temperature of 2–20 C (Pharma LIFT, Cathay Pacific Airways, Hong Kong).

For truck shipments, two firms have partnered to integrate fleet management with cold-chain management. The solution includes wireless sensors as well as software and delivers the data it collects to the user's computer (Mobius TTS system from Cadec Global, Manchester, NH, with TempTracker module based on PIMM Cold Chain Management System from Procuro, San Diego, CA). The integration makes it possible for shippers or other stakeholders to monitor conditions inside tethered and untethered trailers in real time. In addition, if temperatures vary from expected levels, the system sends an alert so corrective measures can be taken.

One international shipper is strengthening its cold-chain support with Competence Centers in emerging markets and regional hubs in Panama, Istanbul, Dubai, and Singapore that are certified to comply with good manufacturing practice and good distribution practice. The shipper provides warehouse and transportation services customized for clinical trials and pan-European, less-than-truckload, temperature-controlled cold-chain road freight capabilities (Life Science strategy, DHL Global Express, Bonn, Germany).


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