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A cold chain is a
supply chain A supply chain is a complex logistics system that consists of facilities that convert raw materials into finished products and distribute them to end consumers or end customers, while supply chain management deals with the flow of goods in distri ...
that uses
refrigeration Refrigeration is any of various types of cooling of a space, substance, or system to lower and/or maintain its temperature below the ambient one (while the removed heat is ejected to a place of higher temperature).IIR International Dictionary of ...
to maintain perishable goods, such as pharmaceuticals, produce or other goods that are temperature-sensitive. Common goods, sometimes called cool cargo, distributed in cold chains include fresh agricultural
produce In American English, produce generally refers to wikt:fresh, fresh List of culinary fruits, fruits and Vegetable, vegetables intended to be Eating, eaten by humans, although other food products such as Dairy product, dairy products or Nut (foo ...
, seafood,
frozen food Freezing food Food preservation, preserves it from the time it is prepared to the time it is eaten. Since early times, farmers, fishermen, and trappers have preserved grains and produce in unheated buildings during the winter season. Freezing foo ...
,
photographic film Photographic film is a strip or sheet of transparent film base coated on one side with a gelatin photographic emulsion, emulsion containing microscopically small light-sensitive silver halide crystals. The sizes and other characteristics of the ...
, chemicals, and pharmaceutical products. The objective of a cold chain is to preserve the integrity and quality of goods such as pharmaceutical products or perishable good from production to consumption. A well functioning, or unbroken, cold chain requires uninterrupted sequence of refrigerated production, storage and distribution activities, along with associated equipment and logistics, which maintain a desired low-temperature interval to keep the safety and quality of perishable or sensitive products. Unlike other goods or merchandise, cold chain goods are
perishable Decomposition is the process by which dead organic substances are broken down into simpler organic or inorganic matter such as carbon dioxide, water, simple sugars and mineral salts. The process is a part of the nutrient cycle and is esse ...
and always en-route towards end use or destination. Adequate cold storage, in particular, can be crucial to prevent food loss and waste.


History

Mobile
refrigeration Refrigeration is any of various types of cooling of a space, substance, or system to lower and/or maintain its temperature below the ambient one (while the removed heat is ejected to a place of higher temperature).IIR International Dictionary of ...
with
ice Ice is water that is frozen into a solid state, typically forming at or below temperatures of 0 ° C, 32 ° F, or 273.15 K. It occurs naturally on Earth, on other planets, in Oort cloud objects, and as interstellar ice. As a naturally oc ...
from the ice trade began with
reefer ship A reefer ship is a refrigerated cargo ship typically used to transport perishable cargo, which require air conditioning, temperature-controlled handling, such as fruits, meat, vegetables, dairy products, and similar items. Description ''Types ...
s and refrigerator cars ( iceboxes on wheels) in the mid-19th century. The term ''cold chain'' was first used in 1908. The first effective cold store in the UK opened in 1882 at
St Katharine Docks St Katharine Docks is a former dock in the St Katherine and Wapping ward of the London Borough of Tower Hamlets. It lies in the East End of London, East End on the north bank of the River Thames, immediately downstream of the Tower of London an ...
. It could hold 59,000 carcasses, and by 1911 cold storage capacity in London had reached 2.84 million carcasses. By 1930 about a thousand refrigerated meat containers were in use which could be switched from road to railway. Mobile mechanical refrigeration was invented by Frederick McKinley Jones, who co-founded Thermo King with entrepreneur Joseph A. "Joe" Numero. In 1938 Numero sold his Cinema Supplies Inc. movie sound equipment business to
RCA RCA Corporation was a major American electronics company, which was founded in 1919 as the Radio Corporation of America. It was initially a patent pool, patent trust owned by General Electric (GE), Westinghouse Electric Corporation, Westinghou ...
to form the new entity, U.S. Thermo Control Company (later the Thermo King Corporation), in partnership with Jones, his engineer. Jones designed a portable air-cooling unit for trucks carrying perishable food, for which they obtained a patent on 12 July 1940, subsequent to a challenge to invent a refrigerated truck over a 1937 golf game by associates of Numero's, Werner Transportation Co. president Harry Werner, and United States Air Conditioning Co. president Al Fineberg, This technology has been frequently in use since the 1950s, when it was most often used for preserving animal-based cells or tissue. As medical breakthroughs, such as in cancer treatment, have taken place, the demand for cold chain systems has grown. The
COVID-19 pandemic The COVID-19 pandemic (also known as the coronavirus pandemic and COVID pandemic), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), began with an disease outbreak, outbreak of COVID-19 in Wuhan, China, in December ...
and its associated
vaccinations Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating ...
, have caused vastly increased need.


Uses

Cold chains are common in the food and
pharmaceutical Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...
industries and also in some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is , but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped.


Produce

Unique to fresh produce cargoes, the cold chain requires to additionally maintain product specific environment parameters which include air quality levels (carbon dioxide, oxygen, humidity and others).


Vaccines

The cold chain is used in the supply of
vaccines A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an ag ...
to distant clinics in hot climates served by poorly developed transport networks. Vaccines can lose their efficacy if cold chain management fails. Disruption of a cold chain due to war may produce consequences similar to the
smallpox Smallpox was an infectious disease caused by Variola virus (often called Smallpox virus), which belongs to the genus '' Orthopoxvirus''. The last naturally occurring case was diagnosed in October 1977, and the World Health Organization (W ...
outbreaks in the Philippines during the
Spanish–American War The Spanish–American War (April 21 – August 13, 1898) was fought between Restoration (Spain), Spain and the United States in 1898. It began with the sinking of the USS Maine (1889), USS ''Maine'' in Havana Harbor in Cuba, and resulted in the ...
, during which the distributed vaccines were inert due to lack of temperature control in transport. For vaccines, there are different types of cold chains. There is an ultralow, or deep freeze, cold chain for vaccines that require -70 degrees C, such as the Ebola and Pfizer–BioNTech COVID-19 vaccines, and some animal vaccines, such as those for chickens. Next the frozen chain requires -20 degrees C. Varicella and zoster vaccinations require this level. Then the refrigerated chain, which requires temperatures between two and eight degrees C. Most flu vaccinations only require refrigeration. In 2020, during the
COVID-19 pandemic The COVID-19 pandemic (also known as the coronavirus pandemic and COVID pandemic), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), began with an disease outbreak, outbreak of COVID-19 in Wuhan, China, in December ...
, vaccines being developed may need ultracold storage and transportation temperatures as cold as , requiring what has been referred to as a "colder chain" infrastructure. This creates some issues of distribution for the Pfizer vaccine. It is estimated that only 25 to 30 countries in the world have the infrastructure for the required ultracold cold chain.


Validation

The cold chain distribution process is an extension of the good manufacturing practice (GMP) environment that all drugs and biological products are required to follow, and are 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. A cold chain can be managed by a
quality management system A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction ( ISO 9001:2015). ...
. Temperature data loggers and
RFID Radio-frequency identification (RFID) uses electromagnetic fields to automatically identify and track tags attached to objects. An RFID system consists of a tiny radio transponder called a tag, a radio receiver, and a transmitter. When tri ...
tags help monitor the temperature history of the truck, reefer container, warehouse, etc. and the temperature history of the product being shipped. They also can help determine the remaining
shelf life Shelf life is the length of time that a commodity may be stored without becoming unfit for use, consumption, or sale. In other words, it might refer to whether a commodity should no longer be on a pantry shelf (unfit for use), or no longer on a s ...
. Also, temperature sensors may need to be
National Institute of Standards and Technology The National Institute of Standards and Technology (NIST) is an agency of the United States Department of Commerce whose mission is to promote American innovation and industrial competitiveness. NIST's activities are organized into Outline of p ...
(NIST) traceable depending on the body monitoring the cold chain.


See also

* Bacterial growth * Pharmaceutical distribution *
Dry ice Dry ice is the solid form of carbon dioxide. It is commonly used for temporary refrigeration as CO2 does not have a liquid state at normal atmospheric pressure and Sublimation (phase transition), sublimes directly from the solid state to the gas ...
* Phase-change material * Frank Vale, cold storage pioneer *
HACCP Hazard analysis and critical control points, or HACCP (), is a systematic preventive approach to food safety from biological hazard, biological, chemical hazard, chemical, and physical hazards in production processes that can cause the finished ...
* Insulated shipping container *
Packaging Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of designing, evaluating, and producing packages. Packaging can be described as a coo ...
*
Shelf life Shelf life is the length of time that a commodity may be stored without becoming unfit for use, consumption, or sale. In other words, it might refer to whether a commodity should no longer be on a pantry shelf (unfit for use), or no longer on a s ...
*
Temperature control Temperature control is a process in which change of temperature of a space (and objects collectively there within), or of a substance, is measured or otherwise detected, and the passage of heat energy into or out of the space or substance is ad ...
* Temperature data logger * Time temperature indicator * Thermal decomposition *
Thermal insulation Thermal insulation is the reduction of heat transfer (i.e., the transfer of thermal energy between objects of differing temperature) between objects in thermal contact or in range of radiative influence. Thermal insulation can be achieved with s ...
*
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 (such as temperature, hu ...
* Transportation management system *
United States Pharmacopeia The ''United States Pharmacopeia'' (''USP'') is a pharmacopeia (compendium of drug information) for the United States published annually by the over 200-year old United States Pharmacopeial Convention (usually also called the USP), a nonprofi ...
* Vaccine storage *
Validation (drug manufacture) The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very i ...
*
Verification and validation Verification and validation (also abbreviated as V&V) are independent procedures that are used together for checking that a product, service, or system meets requirements and specification (technical standard), specifications and that it fulf ...
* ULT freezer


Sources


References


Further reading

* * Brian Lassen, "Is livestock production prepared for an electrically paralysed world?" J. Sci. Food Agric. 2013;93(1):2–4, Explains the vulnerability of the cold chain from electricity dependence. * ''Manual on the Management, Maintenance and Use of Blood Cold Chain Equipment'',
World Health Organization The World Health Organization (WHO) is a list of specialized agencies of the United Nations, specialized agency of the United Nations which coordinates responses to international public health issues and emergencies. It is headquartered in Gen ...
, 2005, * 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, * 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.
dead link 19 November 2008--> * * Nordic Cold Chain Solutions, Manufacturer of temperature-controlled packaging
nordiccoldchain.com
-> {{DEFAULTSORT:Cold Chain Supply chain management Logistics Food safety Temperature control Cooling technology Drug distribution Packaging Ice in transportation Pharmaceutical industry