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Cold Chain Monitoring
Depending on the sector, the product, or the cold chain structure, storage considerations can range from large drive-in spaces to small refrigerators in a clinic.
With the pharmaceutical and life sciences, cold chains require storage of medicines, vaccines, and other products in temperature-controlled packaging and must be maintained within strict temperature boundaries. For example most vaccines need to be stored between 2 to 8°C (36 to 46°F) and temperature outside this range will compromise the vaccine (see The Importance of Proper Vaccine Storage and Handling). Similarly, temperature control is a critical food safety element, as it helps reduce spoilage and prevent foodborne diseases. Fresh produce must be kept at 0 to 16°C or colder, while frozen and deep-frozen foods must generally be kept at 0 to -25°C (32 to -13°F) or colder.
The ability to measure, monitor, and data log temperature becomes a critical aspect of temperature management and a requirement for regulatory compliance.
All storage situations will offer nuances and temperature monitoring needs will vary but they generally fall into three categories:
Measure and monitor basic temperature parameters
Data Logger Monitoring
Automatically measure, monitor, and record parameters over a defined time period, allowing for the download and analysis of collected data
Securely and wirelessly monitor in real time, receive notifications, cloud-based storage, and built-in reports
As the need increases for real-time temperature monitoring, more data management capacity, and the ability to react quickly to regulatory inquiry; cloud-based temperature monitoring is positioned well to meet the demands of the cold chain.
In Part, FDA regulatory code 21 CFR 205.50 refers to both the importance of storage and record keeping in the pharmaceutical industry:
(c) Storage (2) Appropriate manual, electromechanical, or electronic temperature and humidity recording equipment, devices, and/or logs shall be utilized to document proper storage of prescription drugs.
(f) Recordkeeping (3) Records described in this section that are kept at the inspection site or that can be immediately retrieved by computer or other electronic means shall be readily available for authorized inspection during the retention period.
Like the pharmaceutical industry, the food industry is regulated through the Federal Drug Administration (FDA) and the Food Safety Modernization Act (FSMA). Two provisions for consideration in the Food Industry are HARPC (Hazard Analysis and Risk Based Prevention Controls) and the need for monitoring and record keeping.
HARPC requires the food industry to:
- Identify food safety and adulteration hazards associated with foods and processes
- Implement controls to minimize the hazards
- Verify the controls are working
- Design and implement corrective actions to address any deviations outside set control parameters
As the practical and regulatory demands of storage within the cold chain continue to evolve, it is important to ensure your temperature monitoring and data logging capabilities also evolve, particularly as technology moves to wireless connectivity and cloud-based data storage. With temperature being a central component to managing spoilage and preventing foodborne diseases, monitoring and record keeping is critical. Cole-Parmer’s wide range of temperature measurement and data logging devices has been designed to monitor and manage the storage of your valuable product.
Many regulatory bodies will only accept cold chain temperature readings from NIST-traceable products with current certification.
Our cloud-based subscription service meets 21 CFR Part 11 and EU Annex 11.
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