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IPS

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Robert Roy, PE

Sr. Consultant

Barrier Isolation Technology Expert

Areas of Expertise

  • Process Equipment Design and Installation Support
  • Process Modeling and Design of Aseptic Facilities
  • Equipment User Requirements and Specifications and Equipment Selection
  • FDA and EMA Compliance for Aseptic Facilities and Operations
  • Single-use Technologies
  • Potent Material Handling and Containment 
  • Technical Consultancy 
  • Cleaning Validation
  • CIP/SIP System

 

A holistic approach to process definition and integrated facility design at the outset of our projects allows us to achieve our overall objective of “Helping Our Customers Make Product”. Quite simply, our job isn't finished until you are shipping product.

- Robert Roy
Sr. Consultant

Rob is an industry subject matter expert in aseptic fill finish facility design and operation, with over 30 years experience dedicated to all aspects of aseptic processing including operations, qualification/validation, quality assurance, and engineering.   

Rapid development of accurate process models and operational constraints early in the design process facilitates our “Design for OEE” process; wherein process and facility OEE objectives are used to guide design basis process formulation and equipment/technology selections.  A key to the success of this approach is the experience and expertise of IPS personnel in all areas of plant operation, and GMP-centric approach to “Build-In Quality”.

Rob is a current member and former co-chair of the ISPE Sterile Products Processing COP.  He has numerous published articles and is a frequent speaker at industry events and FDA training sessions.  

  • p. 888.366.7660

Recent Projects

  • Biopharmaceutical Fill Finish Greenfield Facility, Process Modeling; Process Equipment Specification and Support
  • Novel Aseptic FFS Equipment Design for IV Solution Bags
  • Aseptic Processing Equipment Design and RA for Novel Transdermal Product 
  • BFS Process Formulation and Filling Equipment Design, Specification and Support
  • Operational Audit Support, Particulate Contamination Audit