The global pharmaceuticals market is forecast to grow to over $1 trillion by 2022 driven by aging demographics in developed countries and rising wealth levels in developing countries. An increasing portion of this market is expected to be biologics, such as those used in gene therapy. Given these growth trends, we expect losses to rise as well unless logistics are put in place that protect the medical products. Improving your existing supply chain to ensure it focuses on precise temperature monitoring and data logging can help you preserve the integrity of your product, save money and provide better treatments for patients.
Problem: the growing complexity of the healthcare industry
Biologics, samples from clinical trials and many classes of medications and medical products are extremely sensitive to heat, humidity and other circumstances. While these items have life-saving capabilities, they are more complicated to research, develop, transport and store. To maintain their effectiveness, different raw materials and finished goods may need to be stored at a variety of temperatures. Any disruption in this temperature or incorrect handling of the product could spoil it permanently. This could result in vaccines that are ineffective, pharmaceuticals and other temperature-sensitive products that must be thrown away or clinical trials that lose valuable data. Beyond this loss, you could also be subject to reputation risk and regulatory action. It’s clear that you need a system that can adapt to the evolving challenges in the healthcare industry.
Solution: implement or improve cold chain logistics
Whether your medical products require constant room temperature or need to be cooled, frozen or deep frozen, implementing cold chain logistics can help ensure temperature monitoring and management at every step of the process. Cold chain logistics refers to managing a supply chain for goods that must be kept at precise temperatures and/or humidity levels. While this has long been prevalent in the food industry, with refrigerated trucks and store rooms for perishable items, this type of supply chain is becoming increasingly important in the healthcare field as well.
Important components include:
- Data logging devices that capture informatics such as temperature, vibration, humidity, etc.
- Hardware for data loggers including:
- Devices placed in manufacturing plants, store rooms, transportation vehicles or with the product to provide temperature monitoring and other readings
- Advanced devices with GPS and RFID capabilities to provide real-time data updates
- Light sensors placed inside packages to verify the product hasn’t been tampered with
- Software that records and analyses all the information from the data loggers
- Packaging with built in temperature monitoring that can actively adjust the temperature of the items as needed
Cold chain regulatory requirements vary by region. In the EU, for example, all medication packaging is required to come with a unique serial number and identifier. Given the complex regulatory landscape – with guidelines coming down from the EU Guide to Good Manufacturing Practice, CDC Guidelines for Maintaining and Managing the Vaccine Cold Chain, and US Code of Federal Regulations – it’s important check with your governing body to ensure your cold chain procedures comply.
As the healthcare industry continues to evolve, technological advances will need to spread beyond the R&D phase to make sure manufacturing and distribution can keep up with the cutting-edge nature of these products. Cold chain solutions which incorporate temperature monitoring and data logging have tremendous potential for preserving the integrity of these products, reducing waste, saving money and improving health and safety.