Pharmaceutical Manufacturing just published an article on Professor Jim McGlothlin’s work at Purdue University’s Exposure Assessment Research Laboratory.
McGlothlin and graduate students at his PEARL lab have developed an extremely useful tool PEARL VEM and how it works that allows workplace hazards (such as particulates, emissions, noise—and human responses such as heart rate) to be recorded in real time, while videos show how operators are using process equipment.
VEM may not eliminate the need for air sampling, but would allow such sampling to be used more strategically, says McGlothlin. It also allows top control priorities to be established.
Users access the wireless system (which involves a laptop PC, sensors and video camera) via a specific IP address; sensor and video data are sent simultaneously to the PC…With this equipment, a company could “vet” a contract API manufacturer halfway across the world. Information can also be stored for future training.
Could the use of such technology smack of “Big Brother?” Perhaps, but it could prove to be a powerful tool in preventing operator error and increasing safety. The story appears below….
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Monitoring Indoor Air Pollution in Real Time
Pharma facilities may not be thought of as environmentally hazardous work environments. After all, GMP and strict safety regulations prevail, and much attention is paid to avoiding cross-contamination.
Yet, the batch processing areas of drug development and pilot plants, particularly those that focus on tableting and solid dosage forms, can pose hidden hazards. And sometimes they’re not that hidden either— for instance, when particulates are made airborne by an operator who doesn’t know how to apply local exhaust ventilation effectively.
Hazardous active pharmaceutical ingredients (HAPI) aren’t the problem, either, explainsPurdueUniversity professor John McGlothlin, who has been studying particulate exposure for several years. “Generally, the higher the ingredient’s potency, the more careful operators are about handling it,” he says. “It’s the less potent materials that can accumulate to have a potentially adverse effect.”
Given that a large portion of pharma’s workforce is female and of childbearing age, protection is critical. But it also makes good economic sense, by preventing the cross-contamination that can destroy batches, as well as the waste that occurs when powders accumulate on the floor and must be vacuumed up.
What’s especially interesting about the work that McGlothlin and the 10 graduate students in his
PEARL laboratory are doing, is the fact that they are applying video exposure monitoring, in a system that includes a sensor, wireless air sampling and video to analyze workplace hazards, and pinpoint the most troubling areas, in real time. Years ago, they’d used radio relay, but now wireless technology and the Internet are expanding the power and potential reach of this technique.
Users access the system via a specific IP address; sensor and video signals are conveyed simultaneously to a wireless laptop computer, where data are collected and analyzed. The cost is minimal, requiring only the computer, sensors, video camera and server, but the Web interface allows global access to real time data, and video, from anywhere in the world. Users can also archive and recall information and use it in future training materials or control systems.
What Purdue provides is proprietary software and a caching system, as well as data encryption. “It’s like a car kit,” says McGlothlin.
The online monitoring technology won’t eliminate the need for dedicated sampling, an expensive procedure that costs hundreds of dollars each time. But it allows one to use such sampling more strategically, and to place additional controls at high-risk process points.
Having such a visual tool has surprised even McGlothlin by what it has revealed. His team has found, for instance, that 90% of the exposure risk typically occurs at only 10% of the points within a given work area and cycle. In tableting operations, for example, the greatest risk of exposure tends to occur in mixing areas, in areas where ingredients are charged from drums into the mixer.
Typically, McGlothlin explains, a local exhaust system is placed near a mixer, but if the operator doesn’t hold the exhaust hose at just the right position near the funnel, particulate concentration can quickly build up in the room. “It’s not a matter of being six inches or one foot off.” says McGlothlin. “Sometimes just a few inches make a big difference.”
The key is consistency in placement of the hose, so that it’s close to the area where the powders are added, but not too close—it should be at the edge of the scoop so that it doesn’t intrude into the scoop.
Video exposure monitoring serves as an excellent training tool, McGlothlin says, but also offers automatic incentives and reinforcement for use of best practices. For example, if monitoring shows that operators have used best practices to lower exposure risks, they may not have to wear as much protective gear the next shift. When they don’t use the right techniques, they must wear additional gear.
The project has evolved over time, and McGlothlin is working with the National Science Foundation (NSF) and the Center for Pharmaceutical Processing Research (CPPR) to commercialize the technology.
So far, each of the CPPR’s 36 members has access to the video exposure monitoring system, and they are sharing findings every few months. McGlothlin’s lab is also applying the technology in a wide variety of other fields and industries, to monitor other environmental factors and responses, including noise and heart rate.
-AMS
