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The Business and Buzz of IoT in Validation

Blog Home | Published: April 3, 2020

The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.  Meanwhile, taking the IoT journey requires commitment, courage, vision and discriminating acuity to manage obstacles and address challenges such as cybersecurity along the way.  The plethora of IoT commercial service providers alone can be daunting. Fortunately, any enterprise embarking on IoT need not proceed alone. Smart organizations learn from those who have gone before, observe their successes and failures, partner effectively with external service providers and adapt the vision strategy and implementation approach according to lessons learned.

Defining a vision, strategy and implementation approach for IoT requires consideration of opportunities to exploit, problems or “pain points” to resolve, and resources available to allocate to realize benefits of implementing IoT. Let’s look at three areas where IoT can make transformational impact of performance and cost benefits:  cold chain distribution, continuous monitoring of manufacturing facilities, and process optimization.

Cold chain distribution monitoring historically has utilized qualitative indicators of cumulative heat exposure.  Heat exposure causes the visual indicator to change color or darkness.  Indicator appearance standards are established which correlate to the amount of heat exposure the product can tolerate and still be suitable for medical use.  While these indicators provide information on product quality, they provide no information of what happened regarding location, timing, cause or duration of temperature excursion.  Electronic temperature recorders, or data loggers, are more contemporary and can provide quantitative information of shipping conditions after a shipment has reached its destination; however, product which exceeds exposure limits would still need to be discarded.  Intelligent cold chain monitors measure and report temperature exposure data to the IoT platform in real time, where data processing algorithms proactively alert supply chain owners of a pending issue or trend which requires intervention to prevent unacceptable exposure well before it occurs. Proactive intervention maintains reliable customer service and eliminates loss of high value product.

Similar concepts apply to manufacturing facilities.  Continuous monitoring of facilities connected to the IoT platform enables advanced data analytics outputs to provide advanced notice of issues; thereby, intervention can be actioned well before a facility event or failure occurs.  By combining these predictive capabilities with data analytics of past performance history, IoT platforms can reduce energy costs and eliminate down time, thereby decreasing cycle time, increasing OEE (Overall Equipment Effectiveness), and reduce overall operational costs.

IoT continuous monitoring applies to pharmaceutical manufacturing processes as well.  Extensive waste remains even after effective application of six sigma and lean principles to manufacturing processes.  By implementing Edge solutions and integrating data streams across process, plant and enterprise levels, IoT enabled high fidelity models, soft sensors and optimality seeking algorithms can reduce process variability by 40 – 60%.  IoT enabled process optimization delivers increased yield, throughput, product quality and supply performance.

IoT platforms connect data and information sources from all parts of operations such as the facility, process, and supply chain examples already discussed.  Interfacing these data with an electronic system can transform complex manual processes like validation into a digital execution system, saving labor and reducing human error.  Labor required for facilities commissioning and qualification, for example, can be reduced by 20 to 30%.  Likewise, cost reductions of up to 80% have been realized by IoT enabled computer system validation.  Similar opportunities are available for equipment qualification, cleaning validation, process validation, analytical method validation, quality event trending, annual product reviews, operational excellence and many other applications.

In summary, by carefully considering vision, strategy and implementation plan, appropriate implementation models and partnerships can be identified for IoT to deliver operational performance to leap ahead of the competition.

Summary

The Internet of Things (IoT), sometimes described as an interconnected enterprise system, creates quite the buzz in business circles today. Connecting data, information, and knowledge certainly carries the potential power of creating intelligence to leap ahead of the competition.



Author

Dr. Alton Johnson

Dr. Johnson has a distinguished pharmaceutical leadership career of over 30 years in new product and process development, technical services, innovation and technology, and advanced manufacturing solutions with Pfizer Inc. As Vice President, Technology and Business Solutions at Pfizer, he led the development and implementation of digital transformation, advanced process control, process analytical technologies, continuous processing, knowledge management, technology transfer, and systems design for rapid development paradigms for accelerated new products. After retiring from Pfizer, he continues to learn and contribute as a consultant. Dr. Johnson served as Chair of the Steering Committee for an Engineering Research Center focused on continuous manufacturing and was a Board Member of the Smart Manufacturing Leadership Coalition. Dr. Johnson earned his Ph.D. degree from Purdue University with research in controlled release, and holds a BS degree in Pharmacy from the University of North Carolina, Chapel Hill.