Onset cold chain monitor targets pharmaceutical applications
March 15, 2016
Massachusetts-based data logger company Onset has introduced the InTemp CX400 pharmaceutical cold chain monitor that combines Bluetooth Low Energy, robust alarm functionality and automated report generation into one logger.
Shifting the temperature just a few degrees higher or lower can render a vaccine ineffective. This potentially leads to millions in lost revenue and, worse, a loss of trust among consumers as word spreads about the need to re-vaccinate.
The CX400 series of pharmaceutical cold chain monitors includes a range of high-performance data loggers for monitoring temperatures in refrigerators, freezers and other temperature-controlled environments. These loggers can then transmit data and alarm states via Bluetooth to any mobile device running the InTemp app. In this way, it provides an affordable and accessible alternative to manually driven monitoring that is susceptible to error and has contributed to vaccine failures around the globe.
It enables clinics, pharmacies, hospitals and pharmaceutical firms to follow the US Centers for Disease Control & Prevention (CDC) recommendation on using digital data loggers for continuous temperature monitoring. Additionally, it meets CDC requirements for calibrated temperature monitoring with devices backed by a certificate of calibration testing.
“The CDC estimates that 13.5 per cent of all refrigerated vaccines are subject to accidental freezing during storage,” said Jessica Frackelton, senior manager of product marketing for Onset. “Many organisations have had to rely on manual temperature monitoring that is susceptible to human error and can jeopardise their vaccine supply and patient safety. With our new InTemp CX400 series, we are making temperature monitoring more accurate, reliable and accessible.”
She said already customers in early testing were reporting that the CX400 provided a new level of ease of use, cost effectiveness and comprehensive functionality that had been lacking in refrigeration and freezer monitoring products.
“We are excited about the benefits that Bluetooth technology can bring to this application and see relevance throughout the pharmaceutical cold chain,” she said. “The idea that customers can gain significant operational benefits while at the same time increasing the quality of life science products dispensed is compelling in transportation, storage and clinical applications as well.”
Designed to simplify compliance with CDC vaccine monitoring guidelines, the CX400 loggers simplify the process by streamlining daily temperature checks, speeding up logger setup and download, and reducing the paper trail burden.
The loggers have an easy-to-read display of the current temperature, as well as the daily minimum and maximum. Featuring ±0.5ËšC accuracy, they provide reliable temperature readings, and deliver audible and visual alarms in the event of a temperature excursion or a disconnected temperature probe. With the Bluetooth-enabled loggers, setup and data download are accomplished in seconds, without the need for a PC or cable, and the devices are battery powered to guard against local power outages.
They are available in several hardware configurations, all of which include an internal temperature sensor. Loggers combining an external probe and glycol bottle ensure the temperature logger readings simulate the actual temperatures of the refrigerated product. Probe-only versions are useful where users need to track actual refrigerator temperatures, and models featuring only an internal sensor are suitable for applications that simply require room temperature monitoring.
The loggers are complemented by the company’s InTemp mobile app. The app enables easy and efficient logger setup. It also allows users to choose from a range of preset configurations – for example, clinical refrigerator or ambient storage monitoring – as well as create custom configurations for other applications as needed.
The app’s ability to download and send data in one step and share reports means employees can meet regulatory compliance requirements for storage monitoring quickly and effectively. It also provides flexibility in transmitting data, so information can be shared with multiple business units or departments. Additionally, the app can create secure PDF reports or export data into Microsoft Excel for analytics, making information accessible for audits. Finally, it ensures security by enabling users to set encrypted passkeys that other mobile devices will require for connection to the logger.