Cold Chain Monitoring

Transport

An important consideration for product quality and integrity is monitoring temperature while product is being transported—all to answer the question “Did my product stay at the appropriate temperature while it was being transported?”

The movement of product through the cold chain can involve various types of transportation, various sizes and quantities of packages, and distances spanning across the city or the continent—all of which makes it challenging to answer this question with confidence. It is crucial to measure, monitor and log temperature during transport, not only to ensure confidence but also for regulatory compliance. Regulation requires the cold chain is maintained and not compromised, and back-up records are available as proof. In the case of the pharmaceutical industry, this is outlined in 21 CFR 203.36 and 21 CFR 211.150. In the food industry, this is outlined in the Food Safety Modernization Act (FSMA) Section 111: Sanitary Transportation of Human and Animal Food.

Key requirements from FSMA Section 111 identifying the importance of temperature monitoring and recording:

Vehicles and transportation equipment: Design and maintenance of vehicles and transportation equipment must ensure the food it transports is kept safe. For example, vehicles must be suitable and adequately cleanable for their intended use and capable of maintaining temperatures necessary for the safe transport of food.

Transportation operations: Measures need to be taken during transportation to ensure food safety. This includes adequate temperature controls, maintaining temperatures, and preventing contamination of ready-to-eat food from touching raw food, protecting of food from contamination by non-food items in the same load or previous load, and protection of food from cross-contact such as the unintentional incorporation of a food allergen.

Records: Maintenance of records of written procedures, agreements and training are required of carriers. The required retention time for these records depends upon the type of record and when the covered activity occurred, but does not exceed 12 months.

Advances in portable, single-use, wireless connectivity and cloud-based temperature monitoring and logging devices have made it easier to follow product as it is being transported—not only to ensure the product has been maintained at the proper temperature, but also to offer documentation of the compliant transportation conditions. Cole-Parmer offers a broad range of Digi-Sense® and Traceable® temperature measurement and data logging devices that provide accuracy, reliability, real-time monitoring, and regulatory compliance—all designed with your confidence in mind.