A temperature-controlled supply chain is essential for the distribution of increasing number of vaccines, biologicals, bio-pharmaceuticals including novel oncology or rheumatology therapeutics. Being complex protein structures these products suffer significant damage when exposed to temperature excursions. Although the pharmaceutical, biotechnology industry has made great progress in manufacturing highest quality product, there is less control over the many factors that may subsequently affect product quality after these TCP products are released and shipped by the manufacturer. Routine handling or unintentional mishandling of these temperature sensitive products may cause degradation that remains unnoticed but can potentially compromise the clinical safety and efficacy of the product.
To maintain the product quality and efficacy of vaccines and biological from manufacturing to the point of use, it is essential to monitor exposure to excessive heat and freezing conditions. Temperature monitoring of storage points, shipments does not provide integrated heat exposure from beginning to end of supply chain.
Hence a solution which registers cumulative heat exposure through shelf life at vial, box level offers effective tool to decide the use of safe and quality product.
Lisaline offers range of temperature indicators from Temptime Corporation , a Zebra Technologies company.
HEATmarker, a miniaturized, self-adhesive label gradually changes color as heat exposure accumulates. This gradual color change indicates when the cumulative heat exposure has exceeded a pre-set limit. This helps ensure that temperature-sensitive products are used before the indicator reaches its end point, and are discarded once endpoint has been reached. HEATmarker VVM has been used to monitor the temperature exposure of vaccines since 1996, as recommended by the WHO and UNICEF . Available with more than 20 temperature profile They are chosen by the manufacturer based on the stability of the product being monitored.
Monitoring of freezing event is recommended for vaccines , biologicals, biopharmaceuticals that are sensitive to freezing , FREEZEmarker, is a single-use freeze indicator that provides an easy-to-read, irreversible visual signal when a freeze event at or below the response temperature occurs. FREEZEmarker indicators affixed on single or multiple vial box level are used to indicate the freezing event during storage and trasnportation