17th Annual Barrier Isolation Technology Forum, Innovation Updates and New Case Studies (E08)

4-5 June
1.2 CEUs		 Working Agenda
Current as of 1 May 2008
Download Working Agenda  PDF, 28 KB 

Stay ahead of the curve on developing technology and regulatory perspectives for barrier isolation, especially in regards to advanced aseptic processing using Restricted Access Barrier Systems (RABS) and isolators. Learn “what to do” as well as “what not to do,” from those with experience.

Content includes background on four technology updates, and seven case studies. An interactive workshop provides access to discussion topics of global importance. Hear from speakers from Europe and North America, and participate in an FDA question and answer session.

Clean in Place (CIP) and e-beam sterilization for introduction of syringe containers into RABS or isolators are a discussion focus with technology updates and a case study for each topic.

Forum presentations include:

  • Technology Update 1: Isolator History and Trends, 2008 Data (Lysfjord)
  • Technology Update 2: Sterile Transfer of Materials into an Isolator Filling Line Using a Novel Electron Beam Emitter (Ross)
  • Technology Update 3: Influence of Humidity, Hydrogen Peroxide Concentration and Condensation on Bio-Decontamination with Gaseous Hydrogen Peroxide (Rauschnabel)
  • Technology Update 4: Automatic Cleaning of an Isolator: CIP versus Foaming In Place (FIP) (Altmann)
  • Case Study 1: Improving the Efficiency of Filling in an Isolator (Enghave)
  • Case Study 2: Case Study of an Application of a CIP Technology to an Isolator (Rush)
  • Case Study 3: Aseptic Containment Vial Processing using Isolator Technology for Clinical Trial Materials (Wyse)
  • Case Study 4: Continuous and Instantaneous Viable and Non-Viable Air Monitoring using Optical Spectroscopy (Miller)
  • Case Study 5: New Generation of Isolators for Freeze Dried Products with Atmosphere Explosive (ATEX) Compliance Approach (Pavan)
  • Case Study 6: US Case Study – Utilizing E-Beam Materials Transfer into an Isolator Syringe Filling Line (Vogt)
  • Case Study 7: Filling Line Isolator with E-Beam for Pre-Filled Syringes (Boesiger)
  • Interactive Group Discussions
  • Agency Question and Answer (Gooen, Friedman, FDA) (Sausville Invited)

How You Will Benefit

At the conclusion of this session, participants will be able to:

  • Describe updated technologies applicable to advanced aseptic processing using RABS and barrier isolation;
  • Understand e-beam technology, CIP technology, and more;
  • Interpret regulatory agency perspectives to streamline your regulatory submission and approval process;
  • Participate in peer discussion groups to seek answers to your questions on advanced aseptic processing issues;
  • Understand what to do and what not to do from those who have done it before; and
  • Apply best practices from case studies.

Who Should Attend

All aseptic processing professionals wishing to stay at the forefront of barrier isolation technologies

Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API), Containment, Heating, Ventilation, and Air Conditioning (HVAC), Process/Product Development (PPD), Project Management (PM), and Sterile Products Processing (SPP)

Seminar Leaders

Speakers

Event Sponsors