- Following FDA’s cGMPs and 21st century initiative, the majority of industries are focusing on modernization solutions.
- As part of the modernization process, working groups must be brought together to debate topics and recommend industry-wide solutions.
- To mitigate issues surrounding microbiological contamination in sterile drugs, FDA recommends isolator technology usage.
Related to this episode:
- Applying Modern Technology to Pharmaceutical Production Facilities
- FDA Discusses Nov. 2023 DSCSA Future State
|Read the transcript below:
Hi, I’m Melissa Griffen, Contributing Editor for Healthcare Packaging. Since the FDA released its current good manufacturing practices and 21st century initiative that includes promoting industry modernization, the majority of industries—including pharma—have gotten onboard the digitalization and Industry 4.0 train.
During the 2021 PDA/FDA Joint Regulatory Conference, three industry panelists and a U.S. FDA regulatory expert discussed various improvements that have come to the industry since the debut of the FDA’s initiative.
James C. Weber, advisor IT in digital manufacturing at Eli Lilly and Company, addressed the benefits of adopting modern technology that Eli Lilly experienced through developing a Global Robotics Program and integrating biometric solutions, both of which furthered the company’s digital plant aspirations.
Weber explained that along with the ergonomic and economic drivers, most players in pharma are pursuing some type of robotics program, which moved Eli Lilly to develop its own program. Efforts began in 2017 in establishing central staffing and funding with site experts developing solutions that ranged from automated logistics operations to automated cleaning, flexible aseptic filling, and more.
A specific robotic solution brought up by the two other industry panelists, Carl-Helmut Coulon, PhD and head of future manufacturing concepts at Invite GmbH, and David Wolton, engineering technology lead at Takeda, was autonomous mobile robots or AMRs. These robots work 24/7, do not host viruses or bacteria like humans, are cleaner overall, and are ideal for repetitive or manual tasks.
Coulon and Wolton further brought up a concern surrounding AMRs. These robots are commonly used for the delivery and removal of items, such as waste, consumables, and spare parts, but they are highly expensive assets, often resulting in a company having just one AMR that likely needs to traverse all parts of the facility including air locks. Getting through air locks is the biggest challenge keeping the use of AMRs from becoming widespread.
Wolton and Coulon concluded that a concept for validating automated cleaning of complex equipment taking into account environmental, equipment, and substance features needs to be developed and to do so, engineers and pharmacists must be connected through a working group to debate the topic and recommend a path forward.
Nicholas A. Violand, investigator and drug national expert at ORA, U.S. FDA stated that one of the primary contributors to contamination in drug manufacturing is the personnel, asserting that the greater the level of separation between personnel and operation the greater level of sterility assurance.
Microbiological contamination of drug products purporting to be sterile has continued to be a top 20 observed citation in the drug realm over the last decade according to FDA research, and is mainly caused by operators not following sanitation guidelines. A solution not as widespread as the FDA expected is the use of isolator technology.
Violand listed typical advantages of the closed isolator design, including it being fully closed, with personnel completely separated from aseptic operations; positive pressure with no interventions requiring open doors permitted; and decontamination occurring after initial line setup and any necessary open-door activities.
For more on biometrics benefits, next level opportunities in robotics and biometrics, and suggested solutions in AMR usage, check out the full story at the URL on screen. Thanks and see you next time on Take Five Video with Healthcare Packaging.