Education Sessions

Review of Critical Interfaces (401)

26 October 13.00-17.00 Track: Engineering Design

ISPE CEUs: 0.4

agenda (PDF Current as of 17 October 2008)

The session looks at the part played by specialized transfer technologies, such as split butterfly valves, rapid transfer ports and bag trick connections to allow the transfer of materials from one closed system to another without compromise of the material or the environment. These systems are becoming increasingly critical as the trend to more highly hazardous compounds continues. One speaker will highlight a thoughtful and long term review of these systems presenting their merits and challenges. The potential impact of these systems to reduce costs and improve quality is important and will be explored in light of ISPE’s Risk-MaPP Baseline® Guide and the trend to closed processing. Vendors will be invited to provide samples in “show and tell” opportunity featuring actual equipment so that participants can get hands on experience with help from vendor technical representatives. The session will conclude with a group discussion. Disclaimer: ISPE does not endorse these vendors who will be invited to attend at a premium. This session will have more of a commercial aspect to it than most ISPE education, but the benefit of being able to see the equipment and discuss advantages and disadvantages is an important part of this session.

How You Will Benefit

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

  • Understand the issues raised by these systems
  • Explain how the varying systems work
  • Discuss the critical issues raised by these devices when solving a problem or meeting a need
  • Explain the pros and cons of various equipment options
  • Analyze competing systems

Technical Documents - www.ISPE.org/publications

ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment, and the ISPE Baseline® Guide Series

Who Should Attend

Anyone contemplating closed processes for aseptic, occupational and product protection including those handling compounds of concern: hormones, cytotoxins, cytostatics, mutagens, teratogens, sensitizers and carcinogens. This session would be helpful for quality, regulatory, process engineering, aseptic, and operations professionals.

ISPE Communities of Practice (COPs)

Active Pharmaceutical Ingredients (API) and Containment

Proposed Agenda

  • Frame the issues and opportunities
  • Owner- and A/E-focused case studies and dialogue session
  • Supplier-focused case studies and dialogue session
  • Panel discussion/path forward

 

Session Leader

Session Speakers

  • Patrice Cloue, Sr Isolation Tech Specialist, la Calhene Inc, USA
  • Alan George, Product Manager, ILC Dover Inc, USA
  • Ralf Kretzschmar, President, Glatt Systemtechnik GmbH, Germany
  • Paul Richards, Project & Technology Engineer, Pfizer Inc, USA
  • Thomas Smith, Component Sales Manager, GEA Pharma Systems, USA

 

Annual Meeting Sponsors