isolator-barrier integrated robotics
DESCRIPTION
This presentation discusses how isolator-barrier technology integrated with robotics enhances product sterility, aseptic manufacturing flexibility and regulatory compliance.TRANSCRIPT
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Achieving Operational Flexibility With Isolator-Barrier Integrated Robotics
Joshua Russell, Principle Engineer – Life Sciences
Automated Systems of Tacoma, “AST”
June 6, 2011
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• At the conclusion of this session, participants will better understand:– How to leverage various technologies to overcome
common industry challenges and increase manufacturing flexibility
– How ANSI-RIA will aid compliance with cGMP’s– How to leverage robotic flexibility to overcome
manufacturing risks posed by RABS – Effective utilization of robot system flexibility for
aseptically filling various container formats on a single modular platform
– Robot compatibility with aseptic applications
Learning Objectives
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• Business• Dwindling clinical & commercial pipelines• Changing patient / physician
expectations & needs• Cost pressures• Market uncertainty• Current state of manufacturing
technology
Industry Challenges Constraining Flexibility
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EMPIRICALMEDICINE
STRATIFIEDMEDICINE
PERSONALIZEDMEDICINE
Trusheim M, Berndt E, Douglas F, Stratified Medicine: Strategic and Economic Implications of Combining Drugs & Clinical Biomarkers, Nature Reviews Drug Discovery, March 2007
High Volume
Moderate Volume
Low Volume
Dedicated automation
Automated or manual
Automated or manual
TOTAL MANUFACTURING CAPACITY / CAPABILITY
Patient Therapeutic Continuum
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COMMERCIALPHASE 2-3 CLINCAL
PRE & PHASE 1 CLINICAL
High Volume*
Moderate Volume
Low Volume
Dedicated automation
Automated or manual
Automated or manual
TOTAL MANUFACTURING CAPACITY / CAPABILITY
Pathway To Commercial Manufacturing
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Achieving Operational Flexibility
• Meeting Business & Patient Needs• Less segmented capabilities• More effective utilization of resources• Eliminates non-value adding activities• Smaller, simpler flexible facility• Be cost competitive and be adaptive to
changing markets and products• Ultimately ensures product quality and
patient safety
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• Parenteral products carry the greatest risk
• People are the greatest source of risk
• How do we avoid contaminating the product?
Protecting People & Product
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Understanding & Mitigating Product Quality Risks
• Situational awareness
• Identify risk• Risk
seriousness• Mitigate or
eliminate risk• Risk detection
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Understanding & Mitigating Product Quality Risks
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ISO 14644-7-2004, Cleanroom and associated controlled environments – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments), Pg. 10, 2004
Reducing Risk Through Isolator-Barrier Separation
ASSURANCE OF MAINTAINING SEPARATION
PHYSICAL
AERODYNAMICClosed System(Low Risk)
Open System(High Risk)
ISOLATORS
RESTRICTED ACCESS BARRIER SYSTEMS (RABS)
MEANS OF SEPARATION
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• ISPE Definition• “… is an advanced
aseptic processing system…”
• “…can operate as “doors closed” for processing with very low risk of contamination similar to isolators…”
Restricted Access Barrier System (RABS)
Courtesy of Telstar North America
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• Rigid wall enclosure• ISO 5 laminar air flow
(LAF) environment• Automation• Rapid Transfer Ports
(RTPs) & pass throughs• Gloves• High level sporicidal
disinfection
RABS Core Features
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• Open doors • Ergonomics• Aseptic assembly• Maintaining separation• Monitoring environmental
quality• Compatibility with hydrogen
peroxide bio-decontamination
RABS Challenges
OPEN DOORS
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Overcoming RABS Challenges• RABS - “System”• A complete system
includes:– People– Technologies– Integration of people
& technology• Primary Goal: Closed
System Operation– Reduce Risk
“Automation of other process steps, including the use of technologies such as robotics, can further reduce risk to the product.” Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (Pg.10)
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• Control open door interventions
• Control glove port access
• Protect sterile components
• Active fan control (active RABS)
• Awareness lights
Overcoming RABS Challenges: Robotics & Automation
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• Environmental Status - situational awareness– Particulate levels– Differential pressure– Air flow
• Secondary down flow barrier
Overcoming RABS Challenges: Environmental Monitoring
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Overcoming RABS Challenges: Environmental Monitoring• Real Time Data
• Timely Reaction (System & People)
• Process Understanding
• Location Significance
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Overcoming RABS Challenges: Aseptic Assembly
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Overcoming RABS Challenges: Single Use Technologies
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Overcoming RABS Challenges: Ready To Use Containers & Components
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Overcoming RABS Challenges: Ready To Use Containers & Components
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ASEPTiCELL Aseptic Fill / Finish Robotic Workcell
ROBOTIC ASEPTIC CORE – FILL / FINISH
MATERIALIN
MATERIALOUT
STERILE CONTAINERS& STOPPERS
FILLED / FINISH
PRODUCT
Courtesy of Automated Systems of Tacoma
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MODERATE
HIGH
LOW
ASEPTiCELL Aseptic Fill / Finish Robotic Workcell - Separation
• Micro-Facility Concept
• Full Interior & Exterior Separation
• Active RABS – Active Fan Control
• Ergonomics
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• Compatible with new or changing products
• Less complex• Smaller more flexible
facility• Reduced intervention
risk• Isolator-barrier
technology
Leveraging Robotic Flexibility To Increase Capabilities
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Leveraging Robotic Flexibility To Increase Capabilities
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Leveraging Robotic Flexibility To Increase Capabilities
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Leveraging Robotic Flexibility To Increase Capabilities
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• System cleaning & disinfection• Payload & reach• Routing of electrical cabling,
pneumatics, and process tubing• Arm & tooling • Operator interaction (safety)• Experienced system integrator
Additional Considerations About Robotic Isolator-Barrier Integration
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• We Learned:– How to leverage robotics and other available
technologies to overcome common industry challenges
– How ANSI-RIA if properly utilized can aid with regulatory compliance
– Robot design considerations that can help overcome some of the technical challenges associated with RABS
– Effective utilization of robot system flexibility to aseptically fill / finish multiple container types on one modular platform
Summary
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Thank for you attention!
Questions?
Joshua Russell, Principle Engineer – Life SciencesAutomated Systems of Tacoma (AST)
4110 South Washington St.Tacoma, WA 98409
(253) [email protected]