Cold chain

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.

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

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

 

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]

Essential Practices

Here are some key prescriptive aspects and good practices to consider when establishing such a system for warehouse custodians and operators.

1. Infrastructure: Both the sending and receiving warehouses need to be equipped with the necessary refrigeration and temperature monitoring systems to maintain the desired temperature range.

2. SOPs: Detailed standard operating procedures need to be developed and followed at every step of the process, from product preparation, packaging, storage, transportation, to receipt. These procedures ensure that everyone involved understands their roles and responsibilities.

3. Temperature Monitoring: Implement a robust temperature monitoring system that provides real-time data on the temperature conditions during transportation and warehousing.

4. Product Knowledge: Understanding the specific temperature requirements and sensitivity of the products being transported is important for the warehouse. This includes knowing the acceptable limits for "time out of refrigeration" and being aware of any freeze-thaw considerations for the product.

5. Packaging: Proper cold chain packaging is crucial. It should be designed to insulate the product and maintain the desired temperature considering potential exposure to external temperature variations. Important component for packaging is also freezers that are required to freeze the PCM (Phase Change Material) necessary for the packing.

6. Quality Assurance: Regular quality checks and audits are essential to ensure that the cold chain system is working as intended. This includes verifying the effectiveness of the temperature control measures, reviewing SOP adherence.

7. Training: Proper training of all personnel involved in the cold chain process, including warehouse staff, drivers, and those responsible for receiving the products is crucial. They should be aware of how to handle any deviations or emergencies.

8. Documentation: Maintenance of accurate and thorough records of the entire cold chain process, including temperature logs. This documentation is essential for traceability and compliance purposes.

9. Emergency Response Plan: Development of a contingency plan to address unexpected events such as excursions, equipment failures, or transportation delays. Having a clear plan in place ensures that appropriate actions can be taken to minimize the impact on product quality.

10. Power Back Up – Power Back Up for the monitoring and alarm systems is as important as providing power back for the product storage itself. Great focus is required for building contingency measures in case of power failure.

By addressing these key aspects and continuously monitoring and refining the cold chain management system, one can create a reliable and effective end-to-end solution. Focus on innovation and technological solutions includes the leveraging predictive analytics for better decision-making and integrating blockchain for traceability.

See also

• Bacterial growth
• Pharmaceutical distribution
• Dry ice
• Phase-change material
• Frank Vale, cold storage pioneer
• HACCP
• Insulated shipping container
• Packaging
• Shelf life
• Temperature control
• Temperature data logger
• Time temperature indicator
• Thermal decomposition
• Thermal insulation
• Tolerance (engineering)
• Transportation management system
• United States Pharmacopeia
• Vaccine storage
• Validation (drug manufacture)
• Verification and validation
• ULT freezer

Sources

  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.

References

1. "Cold Chain - PAHO/WHO | Pan American Health Organization".
2. https://www.who.int/docs/default-source/searo/india/publications/immunization-handbook-107-198-part2.pdf
3. "The Vaccine Cold Chain" (PDF). www.who.int. WHO. Retrieved 19 December 2020.
4. Kohli, Pawanexh. "Fruits and Vegetables Post-Harvest Care: The Basics" (PDF). CrossTree techno-visors. Retrieved 6 April 2009.^{[dead link]}
5. Gyesley, S. W. (1991). "Total Systems Approach to Predict Shelf Life of Packaged Foods". ASTM STP 1113-EB. {{cite journal}}: Cite journal requires |journal= (help)
6. Lou Smyrlis (19 September 2013). "CN's Claude Mongeau preaches 'eco-system of collaboration' at Port Days" 21 September 2013 at the Wayback Machine, Canadian Transportation Logistics, Retrieved 20 September 2013
7. The State of Food and Agriculture 2019. Moving forward on food loss and waste reduction, In brief. Rome: FAO. 2019. p. 12.
8. "FRIDGE SPACE - Bibliothèque et Archives Canada".
9. Otter, Chris (2020). Diet for a large planet. USA: University of Chicago Press. p. 45. ISBN 978-0-226-69710-9.
10. "Frederick McKinley Jones". Minnesota Science and Technology Hall of Fame. Minnesota High Tech Association / Science Museum of Minnesota. Retrieved 11 February 2010.
11. Smith, Jessie Carney (2012). Black Firsts: 4,000 Ground-Breaking and Pioneering Historical Events. Visible Ink Press. p. 613. ISBN 978-1-57859-424-5.
12. Eight Black American Inventors by Robert C. Hayden Addison-Wesley, 1972; pp. 46- 50.
13. "Air Conditioning and Refrigeration History - part 4 - Greatest Engineering Achievements of the Twentieth Century". www.greatachievements.org. from the original on 3 December 2016. Retrieved 24 April 2018.
14. Kelly, Kate (15 December 2020). "Critical to Vaccines, Cold Storage Is Wall Street's Shiny New Thing". The New York Times. Retrieved 20 December 2020.
15. Pambudi, Nugroho Agung; Sarifudin, Alfan; Gandidi, Indra Mamad; Romadhon, Rahmat (2022). "Vaccine cold chain management and cold storage technology to address the challenges of vaccination programs". Energy Reports. 8: 955–972. doi:10.1016/j.egyr.2021.12.039. ISSN 2352-4847. S2CID 245490703.
16. "Office of Medical History". history.amedd.army.mil. from the original on 16 February 2017. Retrieved 24 April 2018.
17. Fischetti, Mark (19 November 2020). . www.scientificamerican.com. Scientific American. Archived from the original on 19 December 2020. Retrieved 20 December 2020.
18. Derek Lowe (31 August 2020). "Cold Chain (And Colder Chain) Distribution". Science Translational Medicine. Retrieved 5 September 2020.
19. Riva, Marco; Piergiovanni, Schiraldi, Luciano; Schiraldi, Alberto (January 2001). "Performances of time-temperature indicators in the study of temperature exposure of packaged fresh foods". Packaging Technology and Science. 14 (1): 1–39. doi:10.1002/pts.521. S2CID 108566613.
20. Meyers, T (June 2007). "RFID Shelf-life Monitoring Helps Resolve Disputes". RFID Journal. from the original on 30 June 2009.
21. "Cold Chain Temperature Monitoring – Absolute Automation Blog". absoluteautomation.com. 27 May 2016. from the original on 24 April 2018. Retrieved 24 April 2018.
22. Yurtseven, C., Ekren, B. Y., & Toy, A. O. (2022). An Overview of Warehouse Operations for Cold Chain. In Industrial Engineering in the Internet-of-Things World: Selected Papers from the Virtual Global Joint Conference on Industrial Engineering and Its Application Areas, GJCIE 2020, August 14–15, 2020 (pp. 161-175). Springer International Publishing. https://link.springer.com/chapter/10.1007/978-3-030-76724-2_13
23. Bishara, R. H. (2006). Cold chain management–an essential component of the global pharmaceutical supply chain. American Pharmaceutical Review, 9(1), 105-109. https://intelsius.com/wp-content/uploads/2011/10/Pharma-Cold-Chain-Bishara_APR.pdf
24. Who, W. H. O. (2010). Good Distribution Practices for Pharmaceutical Products. Technical Report Series. World Health Organization, Annex, 5. https://www.cls.co.at/media/files/who_gdp_tr957_annex5_cls_co_at.pdf
25. "TRS 1025 - Annex 7: Good storage and distribution practices for medical products".

Further reading

• Brecht, Jeffrey K.; Sargent, Steven A.; Brecht, Patrick E.; Saenz, Jorge; Rodowick, Leonard (2019). Protecting Perishable Foods During Transport by Truck and Rail. Supersedes USDA Handbook 669 of 1995. Document HS1328 of the Horticultural Sciences Department, Institute of Food and Agricultural Sciences, University of Florida. Retrieved 9 May 2023.
• 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, 2005, ISBN 92-4-154673-5
• 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 0-7514-0391-1
• 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.
• Rees, Jonathan (2013). "Chapter 1: Inventing the cold chain". Refrigeration Nation: A History of Ice, Appliances, and Enterprise in America. Studies in Industry and Society. Johns Hopkins University Press. pp. 11–30. ISBN 9781421411064.
• Nordic Cold Chain Solutions, Manufacturer of temperature-controlled packaging, nordiccoldchain.com-->