Industry 4.0 is Real
It’s hard to believe that 20 years have passed since the FDA published its 2002 Pharmaceutical CGMP Initiative for the 21st Century. Its mission was to modernize the regulatory approach for human drugs and biologics. Today, transformation is under way in both the FDA’s focus and industry’s engagement with digitalization.
Healthcare Packaging published this discussion of where we are in the next-generation industrial revolution. At the 2021 PDA/FDA Joint Regulatory Conference, a panel of experts shared their insights. James Weber, advisor IT, digital manufacturing, Eli Lilly and Company explained their experience with robotics capabilities and benefits. The organization began its updating in 2017 through dedicated staff and funding to explore robotics opportunities. This investment led to solutions across supply chain, drug manufacturing, cleaning and aseptic filling, among others. Biometrics were also identified as a value center.
Panelists Dave Wolton, engineering technology lead, Takeda, and Carl-Helmut Coulon, PhD, head of future manufacturing concepts, Invite GmbH, talked about promising potential and growing demand for autonomous mobile robots (AMRs). Already entrenched within healthcare environments, refinements for practical applications in cleanroom operation and integration with process equipment are just the beginning.
While there is plenty of room for improvement as technology is optimized for pharmaceutical manufacturing, we found this to be a worthy idea starter for every med tech team.