Cold Chain Monitoring

Verify
data from your transportation or distribution company
Prove
you are in compliance with regulations
Be ready
for GMP audits and to react before loss of inventory

Whether your cold chain is short or long, each hand-off opens the door for risk. It's often not enough to assume your product integrity is safe. Without reliable, consistent temperature monitoring and data logging, especially during storage and transport, you will not know if your product gets to the customer uncompromised.


Storage

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.

Cold Chain Storage

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:

basic temperature monitoring Basic Monitoring
Measure and monitor basic temperature parameters

data logging temperature monitoring Data Logger Monitoring
Automatically measure, monitor, and record parameters over a defined time period, allowing for the download and analysis of collected data

data logger Cloud Monitoring
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.


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?”

maintaining cold chain during transport 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.


TraceableLIVE
REMOTE MONITORING WITH TRACEABLELIVE

Everyone on your team can receive email, text, and push notifications on the environments you monitor.


NIST-Traceable Products— why They matter!

Many regulatory bodies will only accept cold chain temperature readings from NIST-traceable products with current certification.

Traceable Products
Traceable LIVE

Get alerts before losing inventory

Our cloud-based subscription service meets 21 CFR Part 11 and EU Annex 11.

Regulation is increasing
FDA, CFIA, WHO logo

Temperature/humidity regulations in the pharmaceutical and food industries are on the rise worldwide.

Pharmaceutical industry:

  • FDA (21CFR part 11, DSCSA)
  • EMA (GDP)
  • VFC
  • Annex 11
  • CRC (c.870)

Food & Beverage Industry:

  • FDA (21CFR 117, FSMA, cGMPs, HACCP)
  • EMA (GDP)

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