Achieving Operational Flexibility With Isolator-Barrier Integrated Robotics

Joshua Russell, Principle Engineer – Life Sciences

Automated Systems of Tacoma, “AST”

June 6, 2011

• 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

• Business• Dwindling clinical & commercial pipelines• Changing patient / physician

expectations & needs• Cost pressures• Market uncertainty• Current state of manufacturing

technology

Industry Challenges Constraining Flexibility

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

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

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

• Parenteral products carry the greatest risk

• People are the greatest source of risk

• How do we avoid contaminating the product?

Protecting People & Product

Understanding & Mitigating Product Quality Risks

• Situational awareness

• Identify risk• Risk

seriousness• Mitigate or

eliminate risk• Risk detection

Understanding & Mitigating Product Quality Risks

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

• 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

• 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

• Open doors • Ergonomics• Aseptic assembly• Maintaining separation• Monitoring environmental

quality• Compatibility with hydrogen

peroxide bio-decontamination

RABS Challenges

OPEN DOORS

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)

• Control open door interventions

• Control glove port access

• Protect sterile components

• Active fan control (active RABS)

• Awareness lights

Overcoming RABS Challenges: Robotics & Automation

• Environmental Status - situational awareness– Particulate levels– Differential pressure– Air flow

• Secondary down flow barrier

Overcoming RABS Challenges: Environmental Monitoring

Overcoming RABS Challenges: Environmental Monitoring• Real Time Data

• Timely Reaction (System & People)

• Process Understanding

• Location Significance

Overcoming RABS Challenges: Aseptic Assembly

Overcoming RABS Challenges: Single Use Technologies

Overcoming RABS Challenges: Ready To Use Containers & Components

Overcoming RABS Challenges: Ready To Use Containers & Components

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

MODERATE

HIGH

LOW

ASEPTiCELL Aseptic Fill / Finish Robotic Workcell - Separation

• Micro-Facility Concept

• Full Interior & Exterior Separation

• Active RABS – Active Fan Control

• Ergonomics

• Compatible with new or changing products

• Less complex• Smaller more flexible

facility• Reduced intervention

risk• Isolator-barrier

technology

Leveraging Robotic Flexibility To Increase Capabilities

Leveraging Robotic Flexibility To Increase Capabilities

Leveraging Robotic Flexibility To Increase Capabilities

Leveraging Robotic Flexibility To Increase Capabilities

• 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

• 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

Thank for you attention!

Questions?

Joshua Russell, Principle Engineer – Life SciencesAutomated Systems of Tacoma (AST)

4110 South Washington St.Tacoma, WA 98409

(253) 475-0200jrussell@ast-inc.com