Temperature Regulations for every industry

From medical to industrial and everything in between.

Temperature guidelines and regulations are always changing, American Thermal Instruments is committed to providing you with up-to-date information on critical temperature regulations for every industry.

HACCP Compliance


According to the FDA’s website, the Hazard Analysis Critical Control Point, or HACCP, “is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.”

Introduced in the 1960’s, HACCP is now a standard preventative approach that all US manufacturers and producers must follow to avoid pathogens and costly foodborne illnesses. For a company looking to ensure they are compliant, there are several steps you must take to ensure your HAACP bases are covered.

HACCP is an effective and rational means of assuring food safety from harvest to consumption, but something that sounds simple is full of complex steps to ensure proper compliance with the act.

Before embarking on a compliance journey, ensure management is involved and onboard. For a successful HACCP program to be properly implemented, management must be committed to a HACCP approach. A commitment by management will indicate an awareness of the benefits and costs of HACCP and include education and training of employees. Benefits, in addition to enhanced assurance of food safety, are better use of resources and timely response to problems.


Note: The following steps and explanations can be found in the FDA’s Guidelines for Application of HACCP Principles

Step 1: Assemble the HACCP team
Step 2: Describe the food and its distribution
Step 3: Describe the intended use and consumers of the food
Step 4: Develop a flow diagram which describes the process
Step 5: Verify the flow diagram
Step 6: Conduct a hazard analysis (Principle 1)
Step 7: Determine critical control points (CCPs) (Principle 2)
Step 8:
Establish critical limits (Principle 3)
Step 9:
Establish monitoring procedures (Principle 4)
Step 10:
Establish corrective actions (Principle 5)
Step 11:
Establish verification procedures (Principle 6)
Step 12:
Establish record-keeping and documentation procedures (Principle 7)

Full Instructions for each step can be found on the FDA’s HACCP site.

Why is the HACCP Important?

The NRDC estimates that up to 40% of the food produced in the US is eventually thrown out, costing an estimated $218 Billion each year. Most retailers believe the primary cause of fresh food waste is poor in-store handling. In fact, most of the factors leading to food waste happen upstream in the supply chain before product reaches the store. Meaning, if food companies spend more time evaluating their supply chain and ensuring proper storage and transportation, they could save the consumer and the environment the waste that comes from spoiled food.

Studies indicate that improper or inadequate temperature management – starting at harvest – is the primary contributor to early spoilage and food waste.



  1. Food freshness – expiration dates vary when temperatures vary – causing spoiled food and unhappy consumers
  2. Consumer safety – when shipped or stored at the wrong temperatures, you have to worry about quality of taste but also consumer
    safety – Bacteria grow most rapidly in the range of temperatures between 40 ° and 140 °F, doubling in number in as little as 20 minutes.
    This range of temperatures is often called the “Danger Zone” in the food industry.

Investing in a temperature monitoring system will not only assure your shipments are fresh and safe, but it will also keep your company
HACCP compliant.




About 48 million people in the U.S. (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention.

FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each of these points to prevent contamination.


The rule establishes requirements for shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food to use sanitary practices to ensure the safety of that food. The requirements do not apply to transportation by ship or air because of limitations in the law. Exceptions to the rules include food that is shipped through the U.S. but will not be distributed or consumed in the U.S.

This rule is one of seven foundational rules proposed since January 2013 to create a modern, risk-based framework for food safety. The goal of this rule is to prevent practices during transportation that create food safety risks, such as failure to properly refrigerate food, inadequate cleaning of vehicles between loads, and failure to properly protect food.

Key Requirements of the final rule establish specific requirements for:

  • Vehicles and transportation equipment: Vehicles and transportation equipment must be designed and maintained in a way that will not compromise food safety. They must be designed for easy cleaning and able to maintain necessary temperatures for safe food transportation.
  • Transportation operations: Measure must be taken end-to-end in food transportation for safety assurance such as appropriate temperature control, contamination prevention from ready-to-eat foods touching raw foods, accidental incorporation of food allergens, and contamination from non-food items transported in the same load or previously in the same container.
  • Training: Carriers must be trained in sanitary transportation practices and be able to provide documentation of completed training. They must also provide food safety training to all operations personnel responsible for sanitary conditions during transport.
  • Records: Carriers are required to maintain records of written procedures, agreements and training.



Under the FSMA, covered facilities, FDA section 415 requires domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with FDA, and are required to have and implement a written food safety plan that includes:

  • Hazard analysis
  • Preventive controls
  • Process controls   
  • Food allergen controls
  • Sanitation controls  
  • Oversight and management of preventive controls
  • Monitoring:
  • Corrections and Corrective actions
  • Verification
  • Recall plan
  • Supply chain program

The supply chain program requires that manufacturers implement a risk-based analysis of potential hazards that may require a preventive control and that the control will be applied in the facility’s supply chain. Their responsibility includes every part of the supply chain that they control and also that raw materials or other ingredients “requiring a supply-chain-applied control are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use.”

The idea of prevention is not new. The FDA has established prevention-oriented standards and rules for seafood, juice, and eggs, as has the U.S. Department of Agriculture for meat and poultry. Many in the food industry have pioneered best practices for prevention, but what’s new is the recognition that despite the strengths of the American food system, a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry. Additionally, “the inclusion of supply chain control and environmental control requirements for RTE [ready-to-eat] foods is a necessary focus in today’s food safety environment.”

As part of the Food Safety Modernization Act (FSMA), the Sanitary Transportation of Human and Animal Food rule requires shippers, loaders, carriers, and receivers involved in the transportation of human or animal food to use practices to ensure food safety and is the first-ever regulation around the transportation of food. Under the rule, “if a covered person or company at any point in the transportation chain becomes aware of a possible failure of temperature control or any other condition that may render a food unsafe, that food must not be sold or distributed until a determination of safety is made.” Ultimately, the rule recognizes that meeting the requirements of transporting food safely can be done in a wide variety of ways and allows the parties involved to determine the manner that best meets their particular needs.

CFR Title 21 Part 11

PART 11?

In order to understand a part of the The Code of Federal Regulations Title 21, commonly shortened to FDA 21 CFR, we first should explain what
the regulations are in general. The FDA 21 CFR is reserved for the rules of the Food and Drug Administration. From the FDA’s website, “Each title
(or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year and is usually available here several months later.”

Title 21 CFR Part 11

FDA 21 CFR Part 11 compliance is essential for those FDA regulated companies that wish to use electronic quality records and electronic signatures in place of their paper-based and ink-based counterparts to comply with FDA regulations faster and more efficiently. Failure to comply with Part 11 can result in FDA citations and fines.

Many companies want to make the FDA 21 CFR Part 11 compliance shift not just to comply with the FDA but to save on administrative time that otherwise would have been used to control documentation and quality management processes manually.

Issued by the FDA (Food & Drug Administration) in 1997, the 21 CFR Part 11 rule clearly allows the widest possible use of electronic technology.  This is divided into two main sections – Electronic Records and Electronic Signatures.

These are a natural extension to the traditional use of paper records. Paper records provide data security and can carry handwritten signatures to indicate that certain data is correct and log events, which took place. Attempted corruption of either the data or signatures is readily detectable.

In basic terms, the requirement of Electronic Records is to provide secure data which can provide a high level of confidence as would be the case with paper records. Electronic signatures require that both operators and supervisors can electronically identify themselves in such a way as to be equivalent to handwritten signatures.

The advancement in electronic systems offers significant benefits for data retrieval and storage of data. The FDA developed the 21 CFR Part 11 rule to describe what they require to be comfortable that the electronic records and signatures are secure.

How To Become FDA 21 CFR Compliant

Compliance begins with evaluating your computer systems and paper records. There are several good resources that can help with ensuring your company is compliant like this checklist here.

American Thermal Instruments chemical and electronic solutions partnered with our app and cloud services give our customers the ability to easily be FDA 21 CFR compliant with their temperature data.

CFR Title 21 Part 205


There are two core groups that provide regulations to pharmaceutical companies, the Food and Drug Administration (FDA) of the United States and the World Health Organization (WHO). This chapter is going to focus on the FDA’s Code of Federal Regulations 21 Part 25 and WHO’s temperature regulations.


As temperature sensitive pharmaceutical products continue to rise, it is predicted that the related cold chain industry will grow 65% by 2020. This growth creates a number of obstacles for logistic companies with the largest being how to effectively and safely move this product from manufacturing to market. There are a number of regulations around the pharmaceutical market ranging from drug sample storage and handling to maintaining and managing the vaccine cold chain.

The FDA CFR 21 Part 205 regulation touches on the minimum requirements for storage and handling of prescription drugs and the maintenance of prescription drug distribution records. The regulation describes the way prescriptions drugs are to be stored, warehoused and handled. Beyond the standard size of the facility and the proper operations, they must have storage areas design to provide adequate lighting, ventilation, temperature, humidity and more. Within security and storage it states that all prescription drugs shall be stored at appropriate temperatures and under conditions in accordance with requirements. If no requirements are set for certain prescription drugs, the drug may be kept at “controlled” room temperature to keep the strength and quality. To document proper storage has been kept, manual or electronic temperature and humidity devices should be utilized. When shipping these prescription drugs, each outgoing shipment must be carefully inspected for identity and damage from storage or improper conditions. If any conditions create doubt on the drug’s safety, identity or quality, the drug shall be destroyed or returned to the supplier for investigation.

In general, manufacturers, authorized distributors of record and their representatives shall store and handle all drug samples under conditions that will maintain stability, integrity and effectiveness. It must be verified by electronic record that everything has been done to ensure a safe and secure delivery and storage method all the way to the last mile.

WHO Regulations

WHO (World Health Organization) has standardized International packaging and shipping guidelines for vaccines. WHO specifies low and high temperature ranges that are acceptable for international transport over 48 hours. Vaccine manufacturers must ensure their packaging complies and is fully validated based on the WHO standards. They provide specifications for 3 classes of packaging – A, B and C. Class A identifies that the vaccine must be packed to ensure the warmest temperature in the package does not rise above 8°C for with an ambient temperature of 43°C for a period of 48 hours or more. Class B must be packed to ensure the warmest temperature does not rise above 30°C with an ambient temperature of 43°C for at least 48 hours. Lastly, Class C designates that the package must be kept at 30°C or lower at an ambient temperature of 43°C and does not fall below 2°C in external temperatures of -5°C for at least 48 hours. With such strict guidelines on packaging, temperature monitoring devices ensure the packaging worked in the true shipping environment.

WHO regulations state that temperature monitoring devices should be included in all vaccine shipments. These act as a quick reference for possible temperature exposure and damage and help procurement determine what extent the temperature limits have exceeded.

The quick reference allows the recipient to make a quick decision before actually accepting the shipment. The purchasing group and manufacturer have a true need to know this detailed information so they can identify why it happened and put corrective actions in place to ensure it does not happen again.

When using an electronic temperature device, WHO has minimum standards that should be met. These include but aren’t limited to – the ability to start and stop a device, an initial delay in start, history functionality to provide data, an LCD screen to provide visual display and alarm capabilities. Each electronic device must be attached to a card explaining how to use the device, how to stop and read the device and what to do with the shipment dependent on the what the device displays.

WHO has strict guidelines around route and arrival dates to also ensure the vaccines stay safe and effective. Vaccines should travel by direct route whenever possible. However, if they can’t ship direct, they must go through an airport with cold storage facilities and a temperate climate. The time to reach the final destination must be 48 hours or less, unless otherwise agreed to by UNICEF or other agencies. In addition, accurate cold-chain procedures must be followed, meaning all vaccines must be kept in temperature-controlled environment throughout the shipment process.

All of these details and more can be found within the Vaccine Arrival Report (VAR). This document provides inadequacies in the shipment process and any problems related to the condition of the vaccines at delivery.

While the shipping of pharmaceutical drug products can be challenging, WHO has put a number of standards in place to try to mitigate the risk of providing ineffective or unsafe vaccines throughout the cold chain.