The demands for pharmaceutical cold-chain capacity and compliance are on the rise. The global pharmaceutical industry is growing by 3-6 percent year over year, while temperature-controlled pharma product sales are growing at double the overall industry rate. Meanwhile, only a quarter of biopharma leaders say their companies use temperature and location tracking data to monitor their products in transit.
The problem of temperature excursions is widespread. Pharmaceutical manufacturers lose $15 billion per year in product costs due to cold-chain failures, and that doesn’t include resupply and investigation costs. A 2019 Pelican BioThermal pharma industry survey found that 44.6 percent of respondents said their companies had “multiple temperature excursions” each year, with 41 percent of those excursions taking products four or more degrees outside their proper range.
Product waste drives up prices and can create shortages. Products that reach the market after undetected temperature excursions may be “not only ineffective, but harmful and possibly even life-threatening,” according to a report in the journal Pharmacy and Therapeutics.
More comprehensive temperature control and data collection in transit can help protect products and patients. It’s just a matter of implementing those improvements. Only a quarter of respondents in Pelican’s survey said their companies use these types of tracking now.
Protecting pharma products in transit
Equipment malfunctions, waits in exposed locations, delays, and human error can all cause temperature excursions for products that need refrigeration, freezing or protection from freezing. Wireless sensors can detect and report these excursions. And today’s wireless industrial internet of things (IIoT) sensors are small and cost-effective enough to deploy in product packaging, shipping containers, and vehicles at every stage of transit.
Because wireless sensors can continuously feed data to the cloud, logistics managers can track shipment temperatures from any location. This eliminates the need to wait for local servers to update databases with input from wired systems. Real-time monitoring systems can also generate alerts when packages or equipment are out of temperature compliance. The alerts allow logistics managers to flag and remove compromised product before it reaches patients.
When temperature sensors are combined with location trackers, the alerts can pinpoint problem links in the cold chain. That allows for rapid adjustments to prevent future product damage. These capabilities can reduce the need for product recalls and protect the health of patients.
Improving regulatory compliance
Global pharma companies must contend with a patchwork of regulations of temperature controls. Federal agencies in the U.S., the EU and other countries, as well as the International Air Transport Association, all have their own standards for temperature-controlled transportation of pharmaceutical products. The real-time data generated by IIoT monitoring systems makes it easier to track compliance. It also provides a wealth of easily accessible temperature and product location data in case of an audit.
Reducing cold-chain equipment downtime
Wireless sensors that monitor the temperature and vibration of cold-chain equipment can also reduce unplanned equipment downtime that causes product waste. IIoT-driven predictive maintenance uses real-time data and analytics to predict when equipment will need service or replacement.
Predictive maintenance programs can make these determinations much earlier than a preventive-maintenance technician can. That gives managers a longer horizon for maintenance planning and budgeting. Using wireless sensors and IIoT analytics to monitor equipment can also delay the need to invest in newer, costlier smart equipment.
IIoT systems can give real-time insight into product conditions and equipment function. This technology can reduce product waste, identify cold-chain problems, deliver product more safely, and reduce unplanned downtime. This is the cold-chain technology we need to meet the demands of a growing global pharmaceutical market.