Temperature-sensitive drugs nedd to be transported, handled and stored within a defined temperature band in order to retain their effectiveness.
But impaired batches can only be systematically identified and withdrawn from further distribution if the cold chain is seamlessly monitored and documented. Schreiner MediPharm's e-temp-system is designed to achieve this.
The company says its second-generation system has already proven its viability in pilot tests and is now making its way into the marketplace.
Described as low-cost, it is the size of a credit card (1.5 mm thick) and can either be applied to the packaging or product as a self-adhesive label or inserted as a card. The label is programmed using e-temp software
which re meets the special requirements of the pharmaceutical industry, such as 21 CFR Part 11. Customer-specific operating parameters can be programmed, and the measurement data analysed and evaluated.
The open architecture of the software means that new RFID-based sensor technologies can be easily integrated and operated as well.
Up to 690 measured values can be stored on the label. Furthermore, with its 16 bytes of storage capacity, the second e-temp generation offers the possibility to store customer-specific data such as batch numbers on the label.
The labels are optimally suited for use in the temperature range from -20°C up to +50°C. Thanks to an integrated battery, the labels provide up to one year of service, allow a minimum of 20,000 measurements and are suitable for multiple usage. This means labels not require any recalibration throughout their entire service life, resulting in time and cost-savings.