Are you new to cold chain? Or maybe you are looking for a refresher on the subject? Today, we want to cover the basics and define cold chain. Grab some coffee, take a seat and let’s begin:
- Cold Chain is a term used to characterize temperature-controlled storage, distribution and transportation. The term can be misleading since it does not refer to “cold” temperatures in particular.
- Products that are sensitive to temperature variations, whether they be perishables such as fruits and vegetables or more sophisticated drugs and medical devices, are included in the term “cold chain.”
- Cold chain is often more narrowly used in reference to temperature and time-sensitive high value healthcare products.
- A cold chain is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range.
- A cold chain can be managed by a quality management system. It should be analyzed, measured, controlled, documented and validated.
- Cold Chain management uses its own terminology. Visit the LifeConEx Cold Chain University for access to their cold chain glossary.
- Several temperature ranges are specified in the relevant literature, the most common being controlled-room temperature or CRT (often defined from 15°C to 25°C), but also cool (from 8°C to 15°C), cold or refrigerated (from 2°C to 8°C), frozen (around -10°C) and cryogenic (around -150°C).
- The cold chain distribution process is an extension of the good manufacturing practice (GMP) environment that all drugs and biological products are required to adhere to, enforced by the various health regulatory bodies.
- The distribution process must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug substance.
- As applied to cold chain, 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.
How do you or your organisation define cold chain? Share your definition with the community by posting a comment below.
Vivian Berni, Senior Advisor, Optimisation
I am a science and technology explorer who is connecting the dots within the life sciences and health care sectors. Logistics and supply chain management are just some of the many variables that I consider daily. Within LifeConEx/DHL, I’m keeping tabs on industry trends while looking for ways to optimise my customers’ business. Prior to this, I was a driver of innovation who was responsible for project implementations affecting customer journey, branding and ideation. Email thoughts, tips and questions to firstname.lastname@example.org or follow me on Twitter @vivianberni.