Cold Chain Monitoring in Pharma Logistics

cold chain monitoring pharma logistics, Überwachung der Kühlkette Pharmalogistik

Cold Chain Monitoring in Pharma Logistics

Interesting post? Share it on:

By 2020, the global cold chain monitoring and tracking market is expected to reach $ 426 billion. Back in 2015 it was only $ 148 billion. The most lucrative segment is the healthcare sector. The Cold Chain Sourcebook by Pharmaceutical Commerce projects that by 2021, pharma cold-chain logistics will be worth $ 16.6 billion. Cold chain monitoring and tracking refers to controlling devices equipped with sensors that ensure the transportation of temperature-sensitive medication at a given temperature-range.

Why is cold chain monitoring and tracking a growing business?

There are three major drivers behind the growing demand for cold chain monitoring and tracking in pharmaceutical cold chain logistics. The first being the transition towards bio-engineered, temperature-sensitive products. The second being tightening regulations for pharma shipments and the last being the growing internationalization of the pharmaceutical supply chain.

  • The turn towards biologically-based products:

The number of bioengineered drugs is steadily increasingBy 2020, 27 of the 50 top selling drugs will be temperature-sensitive biologics, requiring cold chain storage and handling between 2-8 °C. Bioengineered drugs are on the rise due to their high specificity and complexity that matches the natural biological processes in the human body and therefore lowers the risk of adverse effects.

Biologically-based medication is produced in lengthy and cost-intensive biotechnological processes in living, genetically modified organisms or cells. That makes these drugs cost-intensive in their production and expensive for buyers. Bioengineered drugs range between several hundred to several thousand dollars for a set of syringes or pens.

The gained bioengineered protein drugs are highly sensitive towards temperature excursions. If the temperature exceeds or falls below a certain temperature range, the medication´s delicate tertiary structure is being destroyed and the drug gets ineffective. This is why biologically-based drugs demand for special cold chain packaging in logistics procedures, such as insulated packaging, refrigerants and temperature monitoring devices.

  • Tightening regulations for pharma shipments:

In the past few years, regulatory requirements on the pharmaceutical supply chain have become ever stricter to mitigate risks during cold chain transportation, to ensure patient safety and to assign clear responsibilities for handling the cold chain. Key international regulatory guidance concerning cold chain management are: The EU Guide to Good Manufacturing Practice (Annex 13), the Guidelines on Good Distribution Practice (GDP) of Medicinal Products, CDC Guidelines for Maintaining and Managing the Vaccine Cold Chain, WHO Guidelines on the international packaging and shipping of vaccines, the US Code of Federal Regulations, US and European Pharmacopoeia. The amended GDP guideline of 2013, chapter 9.2 on transportation for instance stipulates that:

The required storage conditions for medicinal products should

be maintained during transportation within the defined limits as

described by the manufacturers or on the outer packaging. (…)

 It is the responsibility of the wholesale distributor to ensure that

vehicles and equipment used to distribute, store or handle

medicinal products are suitable for their use and appropriately

equipped to prevent exposure of the products to conditions that

could affect their quality and packaging integrity

To ensure the required conditions, tracking and monitoring systems have to be in place that constantly measure the product´s condition.

  • Growing internationalization of the pharmaceutical market:

The pharmaceutical supply chain demands for a global approach as manufacturers and distributors work in different regions of the world. They need to transport medication from the US to Russia, from Europe to China. Thus, they are faced with differences in environmental conditions, like temperature variations, that present a potential risk for temperature-sensitive medication. Tracking the drug´s temperature during transportation is hence an essential part of today’s globalized pharma supply chain.

It seems unlikely that the growth in the cold chain monitoring and tracking market is a short-lived one. This transition requires cost-efficient, reliable tracking devices that match the customer´s needs in a flexible manner.

 

Interesting post? Share it on:
Contact

Mon-Fri 9:00AM–5:00PM

+49 (0) 6151 - 80 59 039

info@tec4med.com

Otto-Hesse-Str. 19, 64293 Darmstadt