Effective Cold Chain Management Through Temperature Monitoring

Steps of the Cold Chain Temperature Monitoring Process

1. R&D

The solution contained in the tube is heated to at least 94°C (201.2°F) using a thermal cycler. The heat breaks the hydrogen bonds of the original DNA sample and separates the DNA into single strands (this is termed denaturation of double-stranded DNA).

With TraceableLIVE™, you can stay connected to your critical environments and receive alerts by text, email, or push notification if out-of-range conditions are detected.

2. Manufacturing

The food and pharmaceutical industries must use temperature monitoring and data logging because of the regulations, plus they want to meet GMP and of course provide consumers with quality products. They also need to be prepared for audits by governing bodies. For example, the vaccine industry has regulations to mandate strict monitoring and data logging of temperature for vaccines throughout the entire cold chain. Even a small shift in temperature ranges can cause vaccines to become virtually ineffective. On the other side of the spectrum, industries such as electronic or IT may choose to monitor electronics to ensure the quality of the products during transport.

3. Shipping

Shifts in temperature can happen at any time, especially during transport, although there are regulations being mandated for vehicles used in the cold chain process. Regardless, monitoring during transport can alleviate the question, “Did our products stay at the appropriate temperature 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.

Cold chain monitoring during transport has advanced to more data logging and collecting as much data as possible on the temperature conditions of the product throughout the entire transport process. Temperature data loggers used in the cold chain can be customized according to the cargo/product needs, so if the temperature falls out of range, the worker in charge of the product being shipped can be alerted. They then can manage the next steps to ensure the product gets to the end user uncompromised. With cloud data storage also available, the data logger can store unlimited amounts of data for later use and that data can be exported to CSV or secured PDF.

In addition, disposable data loggers are available and very convenient. After the trip, data is downloaded, and the device does not have to be shipped back to origination. It can be simply disposed. These disposable data loggers are waterproof and can be used in damp environments with ice or cold packs. Some data loggers can be purchased precalibrated, and the user will never have to worry about recalibrating them due to one-time use, which can be a big savings.

The option to subscribe to cloud-based services to upload data is ideal for evaluating data from multiple loggers. The devices can be configured from a smartphone or tablet to start, stop, change memory mode, unit preference, alarm settings, logging intervals, enable/disable alarm. Once all parameters are set, the user simply presses start on the logging device to begin monitoring. Once the shipment is delivered, the device will transmit the data to your mobile device. These devices will give the user the data needed to ensure the cargo remained in the correct temperature range for the entire cold chain transport process.

4. Distribution

When products are stored either before or after transport, the storage temperature is as equally important as the transport temperature. Using devices such as data logging refrigerator or freezer thermometers with wireless capability and calibration can provide peace of mind and keep product temperature in check. They offer an easy and secure way to connect a smartphone, tablet, or personal computer remotely with refrigerators and freezers. Once setup is complete, users can securely monitor parameters 24/7, control alarms remotely, view data logging history, run reports in real time, and give access to other team members. No local software is required to use a cloud-based data interface. Get mobile push notifications, emails, or texts for out-of-range conditions as well.

Many products are calibrated to NIST-traceable standards and ready to use as soon as the user receives it. This means that a 17025-accredited calibration test lab has confirmed that the product meets or exceeds all stated specifications, saving you both time and money by not having to calibrate separately. NIST-traceable calibration also helps meet quality standards and regulatory compliance for ISO, FDA, cGMP, VFC, CAP, CLIA and Joint Commission requirements. See Key regulations for Cold Chain

It’s important to use these types of products for monitoring storage temperatures. The results of storing product or samples at the incorrect temperature has consequences—produce can spoil quicker, biological sample can die, or the effectiveness of a vaccine or drug can be compromised and put the end user at risk.

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 Monitoring - 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
Cloud Monitoring - Securely and wirelessly monitor in real time, receive notifications, cloud-based storage, and built-in reports

LEARN MORE ABOUT TRACEABLE MONITORING

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) Record keeping (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.

5. End user/retail

One way to mitigate risk, ensure and sustain product quality and product freshness, and meet GMP is to invest in reliable and secure temperature tracking devices. Cole-Parmer can help optimize the cold chain process by providing reliable temperature monitoring devices to help track the temperature of products at any stage in the cold chain process. The devices can mitigate risk by providing a record of temperature ranges throughout the journey to ensure that the products are safely in their temperature range. These products can not only monitor temperature ranges during a shipment or while being stored in a warehouse or facility, but the data can be downloaded and stored for analysis to determine out-of-range conditions. This can be very important to industries that need to ensure products are sustained at the quality level needed to provide end users with safe products which is the ultimate goal of cold chain management.

6. Point of Use

Clinics, research labs, blood banks, pharmacies, and supermarkets are just some of the critical destinations at the end of cold chains, and the need for accurate temperature monitoring and reporting doesn’t stop there.

The newly launched Traceable® 7600 Smart Wi-Fi Connected Data Logger is equipped with a touchscreen display, antitampering features, and your choice of swappable probes and sensors for easy calibration.