Cold chain

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Cold chain is a set of rules and procedures that ensure the systematic coordination of activities for ensuring temperature-control of goods while in storage and transit. 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. [1] [2] Cold chain management earned its name as a "chain" because it involves linking a set of storage locations and special transport equipment, required for ensuring that temperature conditions for goods are met, while they are in storage or in transit from production to consumption, akin to the interconnected links of a physical chain.

Contents

An unbroken cold chain is an 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, such as foods and medicines. [3] In other words, the term denotes a low temperature-controlled supply chain network used to ensure and extend the shelf life of products, e.g. fresh agricultural produce, [4] seafood, frozen food, photographic film, chemicals, and pharmaceutical products. [5] Such products, during transport and end-use when in transient storage, are sometimes called cool cargo. [6] Unlike other goods or merchandise, cold chain goods are perishable and always en-route towards end use or destination, even when held temporarily in cold stores and hence commonly referred to as "cargo" during its entire logistics cycle. Adequate cold storage, in particular, can be crucial to prevent quantitative and qualitative food losses. [7]

History

Mobile refrigeration with ice from the ice trade began with reefer ships and refrigerator cars (iceboxes on wheels) in the mid-19th century. [8] The term cold chain was first used in 1908. The first effective cold store in the UK opened in 1882 at St Katharine Docks. [9] It could hold 59,000 carcasses, and by 1911 cold storage capacity in London had reached 2.84 million carcasses. [9] By 1930 about a thousand refrigerated meat containers were in use which could be switched from road to railway. [9]

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 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, [10] for which they obtained a patent on 12 July 1940, [11] 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, [12] [10] [11] [13]

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 and its associated vaccinations, have caused vastly increased need. [14]

Uses

Cold chain being maintained using ice box while transporting polio vaccine VillageReach vaccine cold chain.jpg
Cold chain being maintained using ice box while transporting polio vaccine

Cold chains are common in the food and pharmaceutical industries and also in some chemical shipments. One common temperature range for a cold chain in pharmaceutical industries is 2 to 8 °C (36 to 46 °F), but the specific temperature (and time at temperature) tolerances depend on the actual product being shipped.[ citation needed ]

Produce

Unique to fresh produce cargoes, the cold chain requires to additionally maintain product specific environment parameters [4] which include air quality levels (carbon dioxide, oxygen, humidity and others).[ citation needed ]

Vaccines

The cold chain is used in the supply of vaccines to distant clinics in hot climates served by poorly developed transport networks. Vaccines can lose their efficacy if cold chain management fails. [15] Disruption of a cold chain due to war may produce consequences similar to the smallpox outbreaks in the Philippines during the Spanish–American War, during which the distributed vaccines were inert due to lack of temperature control in transport. [16]

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. [17]

In 2020, during the COVID-19 pandemic, vaccines being developed may need ultracold storage and transportation temperatures as cold as −70 °C (−94 °F), requiring what has been referred to as a "colder chain" infrastructure. [18] 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. [17]

Validation

Slurry ice used to ship sensitive food products Sunwell fish packing pumpable slurry ice.JPG
Slurry ice used to ship sensitive food products
Truck with cooling system FE left view.jpg
Truck with cooling system

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. [18] [3]

A cold chain can be managed by a quality management system. Temperature data loggers and RFID tags help monitor the temperature history of the truck, reefer container, warehouse, etc. and the temperature history of the product being shipped. [19] They also can help determine the remaining shelf life. [20] Also, temperature sensors may need to be National Institute of Standards and Technology (NIST) traceable depending on the body monitoring the cold chain. [21]

Role of warehousing in integrated cold chain management

It is important to understand cold chain management as an integrated system of individual components that come together a seamless system for transportation of goods that can maintain the required temperature range during the period the shipment is in the system. Warehouses at both ends of the transport as well as those in transit are important for maintaining the integrity of the chain. The reason why source and destination warehouses need equal importance is because preparing the cold chain packaging for transport is a very important dimension and is as important as conditioning the product itself for transport. [22]

Regulatory guideless emphasise of strong managerial oversight for the quality systems that ensure integrity of the chain. [23] As per WHO guidelines for good distribution practices, any comprehensive system of quality assurance must be founded on a reliable system of controlling the quality, safety and efficacy of a finished product delivered to a market. It is imperative that all manufacturing operations are carried out in conformity with the accepted norms of GMP. The distribution channel and supply chain need to follow quality assurance as well in order that patients are getting quality medicines. WHO has issued international standards assisting Member States and those involved in the supply chain. [24] [25]

See also

Sources

Definition of Free Cultural Works logo notext.svg  This article incorporates text from a free content work. Licensed under CC BY-SA 3.0( license statement/permission ). Text taken from The State of Food and Agriculture 2019. Moving forward on food loss and waste reduction, In brief , 24, FAO, FAO.

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<span class="mw-page-title-main">Refrigeration</span> Process of moving heat from one location to another in controlled conditions

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. Refrigeration is an artificial, or human-made, cooling method.

<span class="mw-page-title-main">Food storage</span> Type of storage that allows food to be eaten after time

Food storage is a way of decreasing the variability of the food supply in the face of natural, inevitable variability. It allows food to be eaten for some time after harvest rather than solely immediately. It is both a traditional domestic skill and, in the form of food logistics, an important industrial and commercial activity. Food preservation, storage, and transport, including timely delivery to consumers, are important to food security, especially for the majority of people throughout the world who rely on others to produce their food.

<span class="mw-page-title-main">Frozen food</span> Food stored at temperatures below the freezing point of water, for extending its shelf life

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 grains and produce in unheated buildings during the winter season. Freezing food slows decomposition by turning residual moisture into ice, inhibiting the growth of most bacterial species. In the food commodity industry, there are two processes: mechanical and cryogenic. The freezing kinetics is important to preserve the food quality and texture. Quicker freezing generates smaller ice crystals and maintains cellular structure. Cryogenic freezing is the quickest freezing technology available due to the ultra low liquid nitrogen temperature −196 °C (−320 °F).

<span class="mw-page-title-main">Warehouse</span> Building for storing goods and giving services

A warehouse is a building for storing goods. Warehouses are used by manufacturers, importers, exporters, wholesalers, transport businesses, customs, etc. They are usually large plain buildings in industrial parks on the outskirts of cities, towns, or villages.

<span class="mw-page-title-main">Shelf life</span> Length of time that a commodity may be stored before it degrades

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, or no longer on a supermarket shelf. It applies to cosmetics, foods and beverages, medical devices, medicines, explosives, pharmaceutical drugs, chemicals, tyres, batteries, and many other perishable items. In some regions, an advisory best before, mandatory use by or freshness date is required on packaged perishable foods. The concept of expiration date is related but legally distinct in some jurisdictions.

<span class="mw-page-title-main">Freeze drying</span> Low temperature dehydration process

Freeze drying, also known as lyophilization or cryodesiccation, is a low temperature dehydration process that involves freezing the product and lowering pressure, thereby removing the ice by sublimation. This is in contrast to dehydration by most conventional methods that evaporate water using heat.

<span class="mw-page-title-main">Refrigerator car</span> Railroad car designed to carry perishable freight at specific temperatures

A refrigerator car is a refrigerated boxcar (U.S.), 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. Reefers can be ice-cooled, come equipped with any one of a variety of mechanical refrigeration systems, or utilize carbon dioxide as a cooling agent. Milk cars may or may not include a cooling system, but are equipped with high-speed trucks and other modifications that allow them to travel with passenger trains.

<span class="mw-page-title-main">Refrigerated container</span>

A refrigerated container or reefer is an intermodal container used in intermodal freight transport that is capable of refrigeration for the transportation of temperature-sensitive, perishable cargo such as fruits, vegetables, meat, and other similar items.

<span class="mw-page-title-main">Shelf-stable food</span> Foods that can be stored at room temperature

Shelf-stable food is food of a type that can be safely stored at room temperature in a sealed container. This includes foods that would normally be stored refrigerated, but which have been processed so that they can be safely stored at room or ambient temperature for a usefully long shelf life.

<span class="mw-page-title-main">Fish processing</span> Process from catching to selling fish

The term fish processing refers to the processes associated with fish and fish products between the time fish are caught or harvested, and the time the final product is delivered to the customer. Although the term refers specifically to fish, in practice it is extended to cover any aquatic organisms harvested for commercial purposes, whether caught in wild fisheries or harvested from aquaculture or fish farming.

The International Association of Refrigerated Warehouses (IARW) is an inter-warehouse organization. Founded in 1891, IARW was created when a group of conventional (non-refrigerated) warehouse owners began sharing knowledge about storing perishable food. As perishable food storage is complex, this organization soon became known industry-wide for their expertise about temperature controlled storage facilities.

Insulated shipping containers are a type of packaging used to ship temperature sensitive products such as foods, pharmaceuticals, organs, blood, biologic materials, vaccines and chemicals. They are used as part of a cold chain to help maintain product freshness and efficacy. The term can also refer to insulated intermodal containers or insulated swap bodies.

Aseptic processing is a processing technique wherein commercially thermally sterilized liquid products are packaged into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration. Aseptic processing has almost completely replaced in-container sterilization of liquid foods, including milk, fruit juices and concentrates, cream, yogurt, salad dressing, liquid egg, and ice cream mix. There has been an increasing popularity for foods that contain small discrete particles, such as cottage cheese, baby foods, tomato products, fruit and vegetables, soups, and rice desserts.

<span class="mw-page-title-main">Drug packaging</span> Packaging for pharmaceutical preparations

Drug packaging is process of packing pharmaceutical preparations for distribution, and the physical packaging in which they are stored. It involves all of the operations from production through drug distribution channels to the end consumer.

<span class="mw-page-title-main">International Institute of Refrigeration</span> Company

The International Institute of Refrigeration (IIR), is an independent intergovernmental science and technology-based organization which promotes knowledge of refrigeration and associated technologies and applications on a global scale that improve quality of life in a cost-effective and environmentally sustainable manner, including:

Urban freight distribution is the system and process by which goods are collected, transported, and distributed within urban environments. The urban freight system can include seaports, airports, manufacturing facilities, and warehouse/distribution centers that are connected by a network of railroads, rail yards, pipelines, highways, and roadways that enable goods to get to their destinations.

A temperature data logger, also called temperature monitor, is a portable measurement instrument that is capable of autonomously recording temperature over a defined period of time. The digital data can be retrieved, viewed and evaluated after it has been recorded. A data logger is commonly used to monitor shipments in a cold chain and to gather temperature data from diverse field conditions.

The distribution of medications has special drug safety and security considerations. Some drugs require cold chain management in their distribution.

<span class="mw-page-title-main">Deployment of COVID-19 vaccines</span> Distribution and administration of COVID-19 vaccinations

As of 3 January 2024, 13.53 billion COVID-19 vaccine doses have been administered worldwide, with 70.6 percent of the global population having received at least one dose. While 4.19 million vaccines were then being administered daily, only 22.3 percent of people in low-income countries had received at least a first vaccine by September 2022, according to official reports from national health agencies, which are collated by Our World in Data.

<span class="mw-page-title-main">Vaccine storage</span>

Vaccine storage relates to the proper vaccine storage and handling practices from their manufacture to the administration in people. The general standard is the 2–8 °C cold chain for vaccine storage and transportation. This is used for all current US Food and Drug Administration (FDA)-licensed human vaccines and in low and middle-income countries. Exceptions include some vaccines for smallpox, chickenpox, shingles and one of the measles, mumps, and rubella II vaccines, which are transported between −25 °C and −15 °C. Some vaccines, such as the COVID-19 vaccine, require a cooler temperature between −80 °C and −60 °C for storage.

References

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Further reading