Conversations That Matters
ISPE Facilities of the Future Conference in San Fransisco
Shanshan Liu, our technical director and Pierre Winnepenninckx, our CEO were attending ISPE Facilities of the Future conference 2025 happening last week! Here’s a summary of the sessions they attended on Robotics, teleoperation and ditigal twins.
Introduction
This content summarizes key themes and insights from three presentations focusing on the application of advanced technologies in pharmaceutical manufacturing: robotics in aseptic isolators, tele-operated robotics, and digital twins. Delivered at an ISPE conference, these presentations highlight a clear industry shift towards increased automation, reduced human intervention, and the use of digital tools to improve efficiency, quality, and safety.
Robotics in Aseptic Isolators
Robotics as an Enabler for Higher Regulatory Compliance
Speaker: Julian Petersen, Groninger & Co GmbH
Main Theme: Robotics and automation drive higher compliance and improved aseptic processes within isolators, reducing human variability and enhancing product safety and consistency.
Key Insights:
- Contamination Control Strategy (CCS): A strong CCS relies on design principles, with robotics enhancing design-focused strategies for robust contamination control.
- Process Consistency: Robots eliminate process variability, ensuring consistent task execution and improving compliance outcomes.
- Regulatory Evolution: Regulatory bodies, such as those enforcing Annex 1, stress the importance of facility design and automation, reducing dependence on traditional monitoring and testing.
- Advancements in Aseptic Filling: The industry is transitioning from open aseptic processing to closed barrier systems, with a focus on achieving ‘gloveless’ operations supported by robotics.
- Current Applications: Robots are widely used for handling tasks, material transport, and critical manual interventions, enhancing flexibility and minimizing human involvement.
- Challenges and Limitations: Robots are not inherently sterile, must comply with first air requirements, and have constraints related to speed, weight capacity, and spatial demands. They also require specialized operator training.
- Optimizing First Air: Selecting the right robot type is crucial for maintaining laminar airflow, supported by computational fluid dynamics (CFD) analysis.
- Towards Gloveless Operations: Fully automated or telemanipulated systems require the redesign of consumables for robotic compatibility.
- Automation Opportunities: Robotics can be leveraged for tasks such as installing direct/indirect contact parts, environmental monitoring, managing closure blockages, and loading lyophilizers.
- Industry Collaboration: Effective automation requires collaboration between OEMs and consumable suppliers to redesign components for robotic handling.
- Data-Driven Monitoring: The shift towards rapid microbial methods, such as bio-fluorescence and particle counting, aims to replace traditional settle plates.
- Future Vision: Manufacturing lines should be designed around robotics and automation to enhance quality by design and minimize human dependency.
Tele-Operated Robotics
Unlocking the Future: Robot Telemanipulation
Speakers: Bill Rusitzky, SRI International; Jean-Maxime Guay, Pfizer Canada
Main Theme: Tele-operated robotics enables remote human intervention in hazardous or contamination-sensitive environments, addressing the limitations of full automation.
Key Insights:
- Definition: Teleoperation allows for the remote control of robots through immersive interfaces, enabling precise interventions in restricted environments.
- Core Benefits: Provides regulatory compliance, reduces safety risks, and improves cost efficiency.
- Practical Applications: Used in gloveless isolators, potent drug handling, and hazardous area access.
- Proven Effectiveness: Successful mock-ups demonstrate telemanipulation’s viability in complex environments.
- Live Demonstrations: VR-controlled robots showcase ease of use, precision, and responsiveness.
- User-Friendly Design: The intuitive system requires minimal training, making it accessible to diverse operators.
- Comprehensive Data Recording: Ensures traceability and supports process investigations through detailed intervention logs.
- Third-Party Integration: Compatible with widely used robotic arms, enhancing scalability and cost-effectiveness.
- AI Integration: Future plans include incorporating AI to enhance teleoperation and automate repetitive tasks.
- Operational Readiness: The technology is expected to be fully operational by 2025, with foundational components already deployed.
Digital Twins
Driving Innovation in Pharmaceutical Manufacturing
Speakers: Michael Lawlor, Sanofi Waterford; Greg Albertson, Sanofi
Main Theme: Digital twins for equipment and processes optimize manufacturing, accelerate product development, and mitigate risks, advancing the vision of connected smart factories.
Key Insights:
- Connected Smart Factories: Focus on modular facilities that support rapid product changeovers and agile manufacturing.
- Digital Twin Definition: Real-time synchronization between physical assets or processes and their digital counterparts, enabling optimization and predictive simulations.
- Strategic Justification: Digital twins address inefficiencies in equipment and product lifecycles, enhancing quality, speed to market, and operational efficiency.
- Implementation Roadmap: Includes defining objectives, selecting digital twin types, validating data inputs, building simulations, ensuring equivalence, and integrating real-time data.
- Equipment Digital Twins: Digital replicas improve lifecycle management, optimize performance, and reduce downtime.
- Product/Process Digital Twins: Focus on optimizing drug product filling, reducing testing requirements, and accelerating development cycles.
- MVP Testing: Demonstrated process equivalence through extensive real-world trials, ensuring reliability.
- Future Applications: Digital twin adoption will expand across new and existing manufacturing lines.
- Talent Development: Cultivating a digitally skilled workforce is critical to maximizing the benefits of digital twins.
- Regulatory Collaboration: Active engagement with regulatory bodies supports the integration of digital twin technologies.
- GXP Compliance: Digital twins enhance compliance and modernize pharmaceutical manufacturing practices.
- Current Regulatory Status: Used for risk mitigation rather than formal regulatory validation.
- Data Integration: Prefers utilizing existing data collection systems with plant connectivity enhancements.
- Vendor Partnerships: Collaboration with suppliers is essential to ensure successful technology adoption.
Robotic Isolator Q&A
Main Themes: Exploring the transformative impact of robotic automation on pharmaceutical manufacturing processes and strategies for future development.
Key Insights:
- Impact on Operations: The integration of robotics significantly alters manufacturing processes, necessitating adaptive strategies.
- Open Innovation: A shift towards open innovation encourages knowledge sharing and accelerates technology adoption across the industry.
- Strategic Roadmap: Emphasizes collaborative efforts with industry stakeholders to drive continuous improvement and technological advancement.
Conclusion
These presentations collectively illustrate a pharmaceutical industry undergoing transformative change, driven by advanced technologies. Robotics—both within isolator environments and through teleoperation—reduces human error, enhances safety, and ensures consistent, high-quality production. Digital twins play a pivotal role in process optimization, product development acceleration, and risk management. The industry is embracing collaborative innovation, regulatory partnerships, and integrated manufacturing systems, ushering in a new era of automation and digital transformation.
Want to learn more about this event?
Visit ISPE Facilities of the Future 2025 webpage. A big thank you to them for organizing such an insightful conference!
