Monitoring the rest of the cold chain

Considerable attention has been paid in the past five years or so to monitoring temperature and other conditions of delicate biomaterials—either commercial biologics products or clinical trial materials (CTMs)—in life sciences and healthcare. Now, a very simple question with a complex answer needs to be asked: “You’re monitoring the temperature between points A and B,” says Rick Kriss, founder and CEO of Klatu Networks (Poulsbo, WA). “Now, what about A and B?”

According to Kriss, surveys conducted by his company and others of the research labs at major biopharma companies and academic centers reveals that the freezers, cryopreservation equipment and related refrigerators rarely run at optimum mechanical efficiencies and are prone to unexpected failures. One survey shows that as many as half of these units are running out of spec, wasting as much as 22% of the energy consumed during their 24/7/365 operation. “We’re trying to get the industry from a ‘fail and fix’ mentality to a ‘predict and prevent’ model,” he says.

The proposed improvement is Klatu’s Traxx system, which employs battery-powered sensors linked to a Wi-Fi network in the building (Klatu also offers remote monitoring of that network, via an Internet link). The sensors monitor temperature and other relevant conditions of samples, products and CTMs being stored, as well as key operating parameters of the mechanical equipment that provides the cooling. Alarms are configured to provide precise information to lab or facility managers; a module of Traxx called TraxxLink monitors the health of the network connections and sensors themselves.

Purchasers of industrial-scale laboratory freezers and storage units rightly expect their equipment to have sensors and alarms, but Kriss points out that these are rarely networked in an efficient manner, and may or may not provide the mechanical condition monitoring that can predict imminent failure. The loss of samples or research products in the middle of a clinical trial can have disastrous consequences for the research; even more insidious would be overlooking or never recognizing adulterated materials from poorly-maintained equipment. (In an infamous incident from a couple years ago, a lab at Harvard that stored decades worth of human brains involved in autism research lost a major portion of its inventory when freezer alarms malfunctioned.) And while Traxx-style condition monitoring is fairly common in industrial-factory settings (including pharma manufacturing), it is relatively underutilized in lab settings, especially at academic centers.

Kriss says that Traxx has been under development for the better part of a decade, and is now either in use or under active consideration by several leading biopharma companies.