Envisioning Digital Pharma Manufacturing

Pharmaceutical manufacturers should be familiar with the terms “Smart Factory,” or “Pharma 4.0,” which is the International Society for Pharmaceutical Engineering (ISPE)’s trademarked name for Industry 4.0 in pharmaceutical manufacturing. Pharma 4.0 moves beyond automation and strives to use digital technology, including the Industrial Internet of Things (IIoT) and software tools that mine data from large datasets in the cloud, to increase productivity. These tools can be implemented in pharmaceutical process development and in clinical and commercial manufacturing, and many manufacturers in the bio/pharma industry are using them to aid in digital transformation. Yet, misconceptions and limited knowledge remain a barrier for some because digitalization is a new way of thinking and working. At its essence, Pharma 4.0 is a paradigm shift, says Gilad Langer, industry practice lead at Tulip Interfaces. He is currently leading an ISPE Pharma 4.0 Community of Practice subgroup that is preparing to publish a Pharma 4.0 best practice guide in 2023. Industry 4.0 equipment—such as a smart sensor—is autonomous (i.e., plug and produce) and collaborative (i.e., communicates with other equipment or with people using the IIoT), explains Langer. “Pharma 4.0 is a concept that, if adopted wholly and effectively, has the promise of an […]

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