What is Cold Chain? A Guide to Getting Started
Add bookmarkWhat is Cold Chain? A Guide to Getting Started
For any company involved in the transportation of products that are sensitive to atmospheric conditions such as temperature, cold chain logistics is a key concern.
But what exactly do we mean when we say cold chain and what are the regulations and standards that operators must be aware of to ensure compliance in this area?
What is Cold Chain?
The term cold chain refers to a temperature-controlled supply chain that is designed to ensure that the products being transported are kept within a set temperature range to protect their integrity.
Cold chain distribution is particularly important in industries involved in the production or delivery of goods with a limited shelf life, such as pharmaceutical drugs, fresh and frozen foods and chemicals.
The issue is perhaps more critical for pharmaceuticals than any other market, owing to the sector's direct link to health and wellbeing. It is imperative for drugs to reach their final destination in an unspoiled state and any negligence on the part of manufacturers or distributors could have serious consequences.
Increasing Scrutiny
In an article published on the Pharmaceutical Processing website, Jim Tennermann, life science segment manager at Vaisala, a Finnish manufacturer of environmental and industrial measurement products, underlined some key reasons for firms to place a strong focus on cold chain issues.
One is increasing scrutiny from regulators, who will expect operators to be able to prove they can maintain a temperature-controlled supply chain.
The industry has recently seen greater regulatory emphasis on drugs that must be stored at controlled room temperature, which is generally defined as between 20 and 25 degrees C but can extend to between 15 and 30 degrees C.
Mr Tennermann also highlighted the ever-increasing number of biopharmaceutical products coming onto the market. Biopharmaceuticals are medical drugs derived from living systems and organisms that tend to be more sensitive to environmental conditions.
It has been estimated that biologics will account for half of the entire drug market by 2015.
Standards and Regulations
It is crucial for pharmaceutical cold chain operators and distributors to be aware of the latest rules and standards governing the market, but this can sometimes be a daunting task, owing to the complexity of the regulatory landscape.
Different organisations offer varying good distribution practice information in different countries, meaning there could be inconsistencies for companies transporting drugs internationally.
Guidelines are available from the EU, the World Health Organization, the Parenteral Drug Association, the International Air Transport Association and other groups.
Writing for ColdChainInfo.com, Jeff Wodrich, director of biopharma solutions at Pelican Products, suggested that the United States Pharmacopeia could be a good place to start for anyone trying to get to grips with regulations. This organisation is the official standards setting authority for healthcare products made, sold and distributed in the US and many of its directives are recognised around the world.
Companies with drug distribution networks within the EU could start by familiarising themselves with standards enforced by the European Directorate for the Quality of Medicines and Healthcare.
Tips to Get Started
In his article for Pharmaceutical Processing, Mr Tennermann admitted that the rules and demands associated with cold chain logistics can seem bewildering and offered some tips for getting started in the market.
He encouraged operators to gain a solid understanding of their current supply chain and to clarify where their process lies within the wider system. It can help to build relationships with other stakeholders in the supply chain and collaborate to reach a shared goal.
It is also important to remember geographical factors and to consider how aspects of your business may need to change if your scope is likely to expand into different areas.
Tennermann also noted the potential value of using dedicated solution providers, which are likely to have more experience in executing cold chain logistics and dealing with common problems.
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