NIST Certification: How Therma° promotes FDA compliance

In 2010, the CDC released a report on foodborne illness. The CDC concluded that 1 in 6 Americans get sick every year from microbes and chemicals in food caused by a lack of oversight in food production, manufacturing, pharmacy,  and transport. These findings spurred the passing of the Food Safety and Manufacturing Act (FSMA) in 2011, which mandated the use of certified electronic temperature monitoring in food manufacturing. In order to become “certified” temperature monitoring systems must be evaluated for quality. Therma simplifies this process and makes it easy to comply with federal regulations by offering NIST Certification for all its products.

Read on to find out more about food manufacturing gov regulatory standards and how Therma° can help your facility comply with the FSMA.

Revised FDA food safety standards

The FSMA gave the FDA (Food and drug administration)broad authority to oversee and enforce regulations on food supply chains for the first time. One mechanism of the FDA regulation to accomplish this goal required electronic temperature monitoring devices. These storage area devices help manufacturers comply with the following requirements:

• Product Safety Assurance: The FDA mandates that food producers take a science-based standard operating procedure (sop) to quality, including analyzing storage conditions for potential contamination sources.
• Increased Inspection Frequency: This gov rule requires the FDA to inspect facilities at least every three years. 
• Preventive Controls: Every food processing facility (including healthcare) is responsible for creating a plan to mitigate contamination. Controls include monitoring facility temperature and humidity conditions and keeping certifiable records to prove that temperature abuse didn’t occur.  While also ensuring storage area inventory remains at an adequate temperature range. 

Violating these sops comes with penalties that range in severity. 21 CFR is reserved for rules of the Food and Drug Administration.  Some of the lesser consequences include warning letters and court injunctions. Continued violations or refusal to comply with the requested actions will lead to shutdowns, fines, seizures, and even prison time.

In addition to the FSMA, the Good Manufacturing Practice (GMP) regulations have quality management laws, requiring that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood take proactive steps to ensure the product is safe.

Temperature monitoring, NIST calibration, and FDA compliance 

The FDA regulation requires the use of electronic temperature monitoring devices as part of its regulations. Additionally, the FDA  mandates operators produce six months of temperature logs during an inspection. They require this to prove that temperature abuse has not occurred in the handling of products. Records are essential because temperature abuse is one of the five primary factors in contamination outbreaks.

Current ordinances require twice-daily inspections of cold storage areas. Remote monitoring systems, like Therma°, offer a new way to comply with regulations through continuous temperature and humidity recording and temperature change alerts.  

Remote temperature monitoring options

When a manufacturer selects a remote temperature monitoring system, there are various features to consider, such as software integrations, range, cost, and reliability. Types of solutions are grouped roughly into the following categories: 

• Wired Solutions: Wired sensors are embedded into environments and use physical connections to transmit information via Ethernet. Wired solutions are expensive to install, difficult to change or update, and a poor fit for refrigeration equipment that requires a tightly sealed environment.
• Bluetooth and WiFi: These sensors are wireless and rely on Bluetooth and WiFi to transmit data. These devices are often cheaper but are unreliable in steel environments. Freezers and other steel equipment items can create signal difficulties.  
• LoRaWAN Sensors: LoRaWAN, or Long Range Radio, transmits data using 4G instead of Bluetooth and WiFi. LoRaWAN sensors, such as Therma°, communicate data effectively in steel environments and do not require a good WiFi signal to function, allowing for temperature control alerts at any moment.

For more information about how the types of sensors in the market or the importance of software, check out our article on how restaurants evaluate temperature monitoring systems.

NIST calibration certified

While remote temperature monitoring is more reliable than manual temperature checks, the FDA requires scientific proof of its efficacy, meaning verifiable proof that sensor calibration has been performed correctly. In the latest food code, the FDA stipulates that “food temperature measuring devices shall be calibrated per manufacturer’s specifications as necessary to ensure their accuracy.” To accomplish this, the FDA works with the National Institute of Standards and Technology (NIST) to establish criteria for food manufacturers to follow.

NIST is a government agency that regulates measurement and technology validation standards. They determine the efficacy of Sensors by subjecting them to a variety of tests to measure their effectiveness. To become certified, sensor calibration must be proven effective within a +/- 1.8° F degree margin of error.

Therma° provides NIST calibration and certification

To serve the food manufacturing industry, Therma° provides NIST calibration and certification of our sensors on request. We utilize an independent, 3rd party vendor verified by the Department of Commerce. Additionally, Therma’s data is backed up digitally with our easy-to-use record-keeping dashboard and mobile app. Therma° makes temperature-controlling easy to do. When inspectors ask to see your records, Therma’s app allows you to provide them instantly.

Therma° is making cold chain storage sustainable and allowing distributors to receive real-time alerts as a temperature monitoring device. 

To gain the benefits of Therma’s NIST certified and calibrated sensors click below to buy direct.