Cold chain
Encyclopedia
A cold chain is a temperature
Temperature
Temperature is a physical property of matter that quantitatively expresses the common notions of hot and cold. Objects of low temperature are cold, while various degrees of higher temperatures are referred to as warm or hot...

-controlled supply chain
Supply chain
A supply chain is a system of organizations, people, technology, activities, information and resources involved in moving a product or service from supplier to customer. Supply chain activities transform natural resources, raw materials and components into a finished product that is delivered to...

. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life
Shelf life
Shelf life is the length of time that food, drink, medicine, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption...

 of products such as fresh agricultural produce
Produce
Produce is a generalized term for a group of farm-produced goods and, not limited to fruits and vegetables . More specifically, the term "produce" often implies that the products are fresh and generally in the same state as where they were harvested. In supermarkets the term is also used to refer...

, seafood
Seafood
Seafood is any form of marine life regarded as food by humans. Seafoods include fish, molluscs , crustaceans , echinoderms . Edible sea plants, such as some seaweeds and microalgae, are also seafood, and are widely eaten around the world, especially in Asia...

, frozen food
Frozen food
Freezing food preserves it from the time it is prepared to the time it is eaten. Since early times, farmers, fishermen, and trappers have preserved their game and produce in unheated buildings during the winter season. Freezing food slows down decomposition by turning water to ice, making it...

, photographic film, chemicals and pharmaceutical drugs.

Uses

Cold chains are common in the food
Food
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals...

 and pharmaceutical industries and also some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C. but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped.

This is important in the supply of vaccines to distant clinics in hot climates served by poorly developed transport networks. Disruption of a cold chain due to war may produce consequences similar to the Smallpox
Smallpox
Smallpox was an infectious disease unique to humans, caused by either of two virus variants, Variola major and Variola minor. The disease is also known by the Latin names Variola or Variola vera, which is a derivative of the Latin varius, meaning "spotted", or varus, meaning "pimple"...

 outbreaks in the Philippines during the Spanish-American war.

Traditionally all historical stability data developed for vaccines was based on the temperature range of 2-8 °C. With recent development of biological products by former vaccine developers, biologics
Biologics
A biologic is a medicinal product such as a vaccine, blood or blood component, allergenic, somatic cell, gene therapy, tissue, recombinant therapeutic protein, or living cells that are used as therapeutics to treat diseases...

 has fallen into the same category of storage at 2-8 °C due to the nature of the products and the lack of testing these products at wider storage conditions.

The cold chain distribution process is an extension of the good manufacturing practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

 (GMP) environment that all drugs and biological products are required to adhere to, enforced by the various health regulatory bodies. As such, the distribution process must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug substance. The GMP environment requires that all processes that might impact the safety, efficacy or quality of the drug substance must be validated, including storage and distribution of the drug substance.

Validation

A cold chain can be managed by a quality management system
Quality management system
A quality management system can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management.-Elements of a Quality Management System:# Organizational structure# Responsibilities# Methods...

. It should be analyzed, measured, controlled, documented, and validate
Validation (drug manufacture)
Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...

d.

The food industry uses the process of Hazard Analysis and Critical Control Point, HACCP, as a useful tool. Its usage continues into other fields. PDA (Parenteral Drug Association) Technical Report # 39 gives a rough summary of how the cold chain can be validated.

The overall approach to validation
Validation (drug manufacture)
Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...

 of a distribution process is by building more and more qualifications on top of each other to get to a validated state. This is done by executing a Component Qualification on the packaging components. Next, an Operational Qualification that demonstrates the process performs at the operational extremes. The final piece is the Performance Qualification that demonstrates that what happens in the real world is within the limits of what was demonstrated in the Operational Qualification limits.

The PDA's Technical Report states that a Component Qualification is required to demonstrate that a component can be manufactured to the design criteria of that individual component. This was put into the document because the industry did not understand the principles of Validation; all Validation processes were specific to equipment and not auxiliary processes such as shipping/distribution.

Performing thermal testing can also help with validating the cold chain. Certified test labs use environmental chambers to simulate ambient profiles that a package may encounter in the distribution cycle. Thermocouple probes and separate temperature dataloggers measure temperatures within the product load to determine the response of the package to the test conditions. Replicate
Replication (statistics)
In engineering, science, and statistics, replication is the repetition of an experimental condition so that the variability associated with the phenomenon can be estimated. ASTM, in standard E1847, defines replication as "the repetition of the set of all the treatment combinations to be compared in...

 testing based on a qualification protocols is used to create a final qualification report that can be used to defend the configuration when audited by regulators. It is normally best to have an individual that understands the principles of Validation, when defending such processes to a Federal Regulatory body of any nation.

Cold chains need to be evaluated and controlled:
  • Carriers and logistics providers can assist shippers. These providers have the technical ability to link with airlines for real time status, generate web-based export documentation and provide electronic tracking.
  • The use of refrigerator truck
    Refrigerator truck
    A refrigerator truck is a van or truck designed to carry perishable freight at specific temperatures. Like refrigerator cars, refrigerated trucks differ from simple insulated and ventilated vans , neither of which are fitted with cooling apparatus...

    s, refrigerator car
    Refrigerator car
    A refrigerator car is a refrigerated boxcar , a piece of railroad rolling stock designed to carry perishable freight at specific temperatures. Refrigerator cars differ from simple insulated boxcars and ventilated boxcars , neither of which are fitted with cooling apparatus...

    s, reefer ships
    Reefer (ship)
    A refrigerator ship is a type of ship typically used to transport perishable commodities which require temperature-controlled transportation, mostly fruits, meat, fish, vegetables, dairy products and other foodstuffs....

    , reefer containers
    Reefer (container)
    A refrigerated container or reefer is an intermodal container used in intermodal freight transport that is refrigerated for the transportation of temperature sensitive cargo....

    , and refrigerated warehouses is common.
  • Shipment in insulated shipping container
    Insulated shipping container
    Insulated shipping containers are a type of packaging used to ship temperature sensitive products such as foods, pharmaceuticals, and chemicals. They are used as part of a cold chain to help maintain product freshness and efficacy...

    s or other specialised packaging.
  • Temperature data logger
    Data logger
    A data logger is an electronic device that records data over time or in relation to location either with a built in instrument or sensor or via external instruments and sensors. Increasingly, but not entirely, they are based on a digital processor...

    s and RFID tags help monitor the temperature history of the truck, warehouse, etc. and the temperature history of the product being shipped. They also can help determine the remaining shelf life
    Shelf life
    Shelf life is the length of time that food, drink, medicine, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption...

    .
  • Documentation is critical. Each step of the custody chain needs to follow established protocols and to maintain proper records. Customs delays occur due to inaccurate or incomplete customs paperwork, so basic guidelines for creating a commercial invoice should be followed to ensure the proper verbiage, number of copies, and other details.


During the distribution process one should monitor that process until one builds a sufficient data set that clearly demonstrates the process is in compliance and in a state of control. Each time the process does not conform to the process, the event should be properly documented, investigated and corrected so that the temperature excursion do not occur on future shipments. Thus the process is continually evolving and correcting for anomalies that occur in the process. Eventually the process can evolve into periodic monitoring once sufficient data demonstrates that the process is in a state of control. Any anomaly that occurs once a process is in a state of control will result in the process being invalidated and not in control and result in product withdraw from the market to ensure patient safety.

It is necessary to develop an internal documentation system as well as multi-party communication standards and protocols to transfer or create a central repository or hub to track information across the supply chain. These systems would monitor equipment status, product temperature history, and custody chain, etc. These help ensure that a food, pharmaceutical, or vaccine is safe and effective when reaching its intended consumer.

See also

  • Bacterial growth
    Bacterial growth
    250px|right|thumb|Growth is shown as L = log where numbers is the number of colony forming units per ml, versus T Bacterial growth is the division of one bacterium into two daughter cells in a process called binary fission. Providing no mutational event occurs the resulting daughter cells are...

  • Cool Chain Quality Indicator
    Cool Chain Quality Indicator
    The Cool Chain Quality Indicator – established by the Cool Chain Association and Germanischer Lloyd – is an industry standard which measures reliability, quality and skills in temperature-critical logistics like food, flowers and plants, some chemicals, pharmaceuticals and human blood...

     (CCQI)
  • HACCP
  • Insulated shipping container
    Insulated shipping container
    Insulated shipping containers are a type of packaging used to ship temperature sensitive products such as foods, pharmaceuticals, and chemicals. They are used as part of a cold chain to help maintain product freshness and efficacy...

  • Logistics
    Logistics
    Logistics is the management of the flow of goods between the point of origin and the point of destination in order to meet the requirements of customers or corporations. Logistics involves the integration of information, transportation, inventory, warehousing, material handling, and packaging, and...

  • Packaging
  • Shelf life
    Shelf life
    Shelf life is the length of time that food, drink, medicine, chemicals, and many other perishable items are given before they are considered unsuitable for sale, use, or consumption...

  • Specification
  • Temperature control
    Temperature control
    Temperature control is a process in which change of temperature of a space is measured or otherwise detected, and the passage of heat energy into or out of the space is adjusted to achieve a desired average temperature....

  • Time temperature indicator
    Time temperature indicator
    A time temperature indicator is a device or smart label that shows the accumulated time-temperature history of a product. Time temperature indicators are commonly used on food, pharmaceutical, and medical products to indicate exposure to excessive temperature .-Technology:There are a large number...

  • Thermal decomposition
    Thermal decomposition
    Thermal decomposition, or thermolysis, is a chemical decomposition caused by heat. The decomposition temperature of a substance is the temperature at which the substance chemically decomposes....

  • Thermal insulation
    Thermal insulation
    Thermal insulation is the reduction of the effects of the various processes of heat transfer between objects in thermal contact or in range of radiative influence. Heat transfer is the transfer of thermal energy between objects of differing temperature...

  • Tolerance (engineering)
    Tolerance (engineering)
    Engineering tolerance is the permissible limit or limits of variation in# a physical dimension,# a measured value or physical property of a material, manufactured object, system, or service,# other measured values ....

  • Transportation management system
    Transportation management system
    A transportation management system is a subset of supply chain management concerning transportation operations and may be part of an enterprise resource planning system....

  • United States Pharmacopeia
    United States Pharmacopeia
    The United States Pharmacopeia is the official pharmacopeia of the United States, published dually with the National Formulary as the USP-NF. The United States Pharmacopeial Convention is the nonprofit organization that owns the trademark and copyright to the USP-NF and publishes it every year...

  • Validation (drug manufacture)
    Validation (drug manufacture)
    Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...

  • Verification and validation
    Verification and Validation
    In software project management, software testing, and software engineering, verification and validation is the process of checking that a software system meets specifications and that it fulfills its intended purpose...


Further reading

  • Protecting Perishable Foods During Transport by Truck, USDA Handbook 669, 1995, http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3021003
  • "Manual on the Management, Maintenance and Use of Blood Cold Chain Equipment", World Health Organization
    World Health Organization
    The World Health Organization is a specialized agency of the United Nations that acts as a coordinating authority on international public health. Established on 7 April 1948, with headquarters in Geneva, Switzerland, the agency inherited the mandate and resources of its predecessor, the Health...

    , 2005, ISBN 9241546735
  • Pawanexh Kohli, "Fruits and Vegetables Post-Harvest Care: The Basics", Explains why the cold chain is required for fruits and vegetables.
  • Clive, D., "Cold and Chilled Storage Technology", 1997, ISBN 0751403911
  • EN 12830:1999 Temperature recorders for the transport, storage and distribution of chilled, frozen and deep-frozen/quick-frozen food and ice cream
  • Ray Cowland, Developing ISTA Cold Chain Environmental Standards, 2007.
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