Below is a listing of all sessions the speaker is scheduled to present.
Integrated Project Services
Speaker BioRobert L. Roy, PE brings more than twenty years of industry experience with a particular technical expertise in barrier isolation technology, single-use technology, potent material handling and containment, cleaning validation and Clean-In-Place (CIP) and Sterilization-In-Place (SIP) systems. Rob served in several senior level management roles directing global engineering and manufacturing teams on fast-track clinical and commercial scale aseptic fill/finish facilities. He co-developed a flexible isolator configuration enabling isolated formulation and fill/finish operations within a single isolator. Rob has developed and implemented quality and qualification documentation for cleaning, environmental and clean utility monitoring and process validation programs.
|Tuesday, March 29, 2011|
This presentation will focus on Single-use (SU) Systems and their application in advanced aseptic processing fill/finish facilities for sterile drug and biological product manufacturing. Drawing upon project experience and technical knowledge, the speakers will address how disposables and highly flexible equipment is being used throughout the aseptic filling line. They will examine issues relative to the application of single-use equipment for fluid paths, pumps and filling needs. How SU systems eliminate the need for cleaning validation batches and generate faster turnaround/changeover times. There will be an in-depth look at the initial early-stage planning and overall design strategies necessary for success. Early stages include: Concept, Basic Design and Detailed Design. Critical planning discussions will focus on areas such as user requirements, process requirements and impact, improved efficiencies and capacity and space requirements. Finally, the presentation will tie-in the technical planning, risk management and assessment and regulatory issues to successful implement Single-use Systems into Aseptic Fill/Finish Operations.
Upon completion, the attendee will be able to:
• Analyze areas for potential cost savings in new facilities through use of Single-use Disposable Systems.
• Analyze areas for operating efficiency improvements through use of Single-use Disposable Systems.
• Understand potential for improvements in facility regulatory compliance profile, via decreased risk of cross contamination and increased sterility assurance levels.
• Understand potential improvements in operator safety through elimination of equipment cleaning unit operations.