An automated, paperless system closes a cold-chain gap by monitoring refrigerator temperature in pharmacies and dispensing
areas operated by the South Eastern Health and Social Care Trust in Northern Ireland. Wireless sensors regularly check the
temperature of refrigerators where vaccines, erythropoietin, and chemotherapy drugs are stored. Deviations from preset temperature
parameters trigger audiovisual alarms onsite, as well as text messages and emails to key staff members. With the system, the
Trust will be able to develop an archive of historical temperature data and corrective actions to form an audit trail (Wireless
to Web, Kelsius, Belfast). To provide full traceability, the Trust also uses portable data loggers to monitor temperature-sensitive
products during transit to primary-care locations (Portable data loggers, Kelsius).
Another diagnostic toolkit monitors refrigerators and freezers to provide early warnings if temperatures deviate from norms
and also serves as a predictive-maintenance tool. Monitoring labels are activated and positioned at various points inside
the refrigerator or freezer and collect data at intervals even during a power outage. Data are downloaded through a wireless
reader for review and transfer to a personal computer, where they can be stored permanently and analyzed (Ultra TK diagnostic
tool kit, PakSense, Boise, ID).
Conditions in refrigerated truck trailers can be checked through a system that automates remote monitoring of their internal
temperatures as well as the status of the refrigeration units and fuel levels. Based on a mounted passive RFID tag, the system
transmits data in real time, eliminates repeated manual checks, and can be configured to provide alarms if temperature or
fuel levels drift outside predefined thresholds (Yard Hound Reefer yard-management software, PINC Solutions, Berkeley, CA).
On the horizon
The pharmaceutical cold chain remains largely self-regulated. "Everyone puts together their own protocol," says Etienne P.
Snollaerts, chief executive officer of Coldpack.
Many packaging engineers take a conservative stance and overengineer their protective packaging, he notes. For example, many
protocols specify a 2–8 °C temperature range. This narrow window can be challenging to meet and can increase costs if it requires
additional refrigerant or insulation. Although it's generally imperative to prevent freezing, many products suffer no loss
of quality at temperatures slightly above 8 °C, thus making a temperature range wider than 2–8 °C feasible in some cases.
"In fact," says Snollaerts, "up to 16 °C is acceptable for vaccines, according to WHO."
The adoption of less stringent protocols may be supported by work underway on standards. In the United States, a division
of the Parenteral Drug Association is working with ISTA to develop test profiles for the cold chain. Parameters include minimum
load, maximum load, and orientation. If successful, "a 96-h box would meet a standard set of guidelines," explains Lindquist.
He predicts the groups will publish a finalized document before the end of 2010 and that it eventually will serve as the basis
for mandates by the US Food and Drug Administration or the US Pharmacopeia.
He also expects a rising level of regulatory interest in enforcing controlled room-temperature conditions. Maintaining products
at controlled room temperature has been difficult because of a lack of sufficient protective packaging. This situation is
changing as new conductive systems are marketed.
Another change likely to affect cold-chain packaging is the phase-out of disposable packaging. It's already occurring in Europe,
Japan, and China, and Lindquist predicts that similar requirements eventually will be adopted in the US.
"Convincing the pharmaceutical industry to change takes time, but we're sure it's coming," says Snollaerts.
Hallie Forcinio is Pharmaceutical Technology's Packaging Forum editor, 4708 Morningside Drive, Cleveland, OH 44109, tel. 216.351.5824, fax 216.351.5684, email@example.com