The Cold-Chain
Transportation and shipment of temperature-sensitive items in a controlled manner is critical in a wide range of applications. There are considerable challenges that result in damaged products which lack effectiveness and as well large economic losses.
- Improper handling of temperature-sensitive medical products such as, vaccines, biological samples, bio-organisms, chemicals, pharmaceuticals, cells, tissues and organs for transplantation can result in deterioration or loss, which can have a significant negative impact on human health as well as economic loss.
- Temperature-controlled packaging (TCP) is utilized in the shipment of temperature-controlled products. Most of the current TCP systems in use today only have the ability to lower a temperature through cooling or raising a temperature through heating, relative to a reference or set temperature.
- Many biological products require precise temperature control often within a few degrees, yet current systems lack the ability to control the temperature adequately during transportation with demanding conditions related to ambient temperatures. For example, the surrounding temperature of a product can increase to over 30 Celsius during transportation on an airport tarmac during summer and drop significantly in below freezing conditions within the same transport process. Products have been damaged and lost by both excessive high ambient temperatures as well as freezing.
Current Technology
Current temperature sensitive bio-pharmaceutical transport containers do not implement cutting edge technology.
- Passive TCP systems provide cooling from simple ice or gel packs which require up to 24 hours of conditioning to protect against freezing content. Devices provide more protection from heat damage, yet freezing can be equally damaging for biological products including vaccines, biopharmaceuticals, cells and organs for transplant
- Active TCP systems that can provide temperature adjustment (such as thermoelectric heat pumps or electrical ‘Peltier devices’ for cooling or heating purposes), are limited due to their size and the need for large power sources. Battery packs necessary to power these units for expected durations, have safety issues which limit commercial aircraft transportation
- Current devices lack active temperature controls which can immediately respond to changes in ambient conditions to maintain a precise set point temperature, as well as real-time temperature logging, alerts and any ability to remotely respond to temperature degradation through remote control
- Temperature damage is mitigated reactively with possible product discard rather than proactively by actively monitoring and regulating the temperature to avoid vaccine damage