Protecting the Cold Chain - Pharmaceutical Technology

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Protecting the Cold Chain
Makers of temperature-sensitive products constantly seek to ensure proper conditions during shipping and storage.

Pharmaceutical Technology

A data logger with an integral USB port and PDF report generator presents data collected during the journey as a PDF file, thus eliminating the need for installing and qualifying specific software. Once the unit is plugged in, the report may be viewed, printed, e-mailed, or stored on a network. An "X" or check mark in the corner of the screen instantly shows whether a product is acceptable or unacceptable. The USB port also is used to configure the unit. The system monitors multiple trips during a 400-day period, captures 16,000 temperature data points between –35 and 70 C, and supports compliance with 21 CFR Part 11 requirements ("Libero PDF" data logger, Elpro Services Inc., Marietta, OH).

Monitoring in real time is possible with a system that combines a disposable, credit-card-size pallet tag, hardware, and software. During the trip, the tag monitors shipment temperature and wirelessly transmits data to a server that supplies reports and alerts by e-mail or mobile phone ("Smart-Trace Online" monitor, Ceebron Pty. Limited, North Ryde, New South Wales, Australia).

A monitoring system using a battery-assisted passive RFID tag integrates a temperature sensor with data-logging capability, encryption technology, and electronic product code (EPC) data to enable product authentication and provide product information and environmental data ("Lightweight Multistream Encryption" EPC tag with integrated temperature sensor, SecureRF, Westport, CT).

Another data logger that relies on RFID uses a thin, lightweight, passive 13.56-MHz tag that measures 2 in.2 and logs as many as 64,000 readings per trip. Available in disposable and reusable versions, the tag can be programmed to read in increments from 0.1 to 1 C. A handheld scanner programs units and retrieves data ("Logic Temperature Tracker" with "CertiScan" wireless scanner, Intelligent Devices subsidiary of Information Mediary Corp., Ottawa, ON, Canada).

A credit-card-size temperature monitor that consists of a 13.56-MHz RFID chip, a temperature sensor, and a printed battery and antenna records temperature data at intervals ranging from 6 s to 12 h. A reader connected to a laptop provides two-way data transmission and can be used to set the tag's temperature parameters between –20 and 50 C. Data can be downloaded from the card without opening the package. Software developed to meet the requirements of 21 CFR Part 11 stores data in a password-protected database to generate charts and reports. Information also can be exported for use in Excel spreadsheets ("e-temp-label," Schreiner MediPharm, Oberschleissheim, Germany).

An active Wi-Fi tag incorporates a temperature monitor and motion sensor. The former triggers a remote alert if the temperature exceeds a preset threshold. The latter tracks product movement. Three colored light-emitting diodes can be incorporated in the tag to provide a visual display of product status ("AeroScout T2" tag, Aero-Scout, Inc., San Mateo, CA).

Wi-Fi tags also can be integrated with logistics software, specially equipped trailers, global-positioning systems, and central servers to track product paths in real time using a web browser ("AeroScout T2" tag, AeroScout, truck-based "Microlise Tracking Unit" and "Microlise Transport Management Centre" software, Microlise, Eastwood, UK; third party logistics provider, DHL, Bonn, Germany).


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