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Containment Technology Forum: Applying ICH Q9 Principles to Selecting Containment Technology

3–4 December 2008
Barcelona, Spain

Seminar Leaders
Johannes Rauschnabel, Robert Bosch GmbH, Germany
Daniel De Grande, De Grande Consulting, Belgium

• Develop successful solutions to current containment issues
• Consider assessment tools such as ICH Q9 and the new ISPE Risk-MaPP Baseline^® Guide
• Establish a network to support you with on-the-job challenges – including an introduction to ISPE’s Containment Community of Practice (COP)

Increasing containment is necessary to minimise contamination of the operator environment and avoid cross-contamination from one product to the other. Each situation needs to be evaluated on a case-by-case basis, using risk assessment tools such as ICH Q9 and ISPE’s Risk-MaPP Baseline® Guide to identify the appropriate risk controls, as well as set health-based limits to address both cross-contamination and operator protection.

To select appropriate containment technology, a partnership of healthcare professionals with focus on identification of hazards, exposure assessments, risk evaluation and implementation of risk controls - as well as considering the economic and regulatory impact of non-compliance – and engineers has to be implemented.

Both, speakers from industry experts and subject matter experts will use a series of case studies, workshops and update sessions, to enable participants to develop successful solutions to current containment issues. 3 interactive workshops on given scenarios help to develop containment concepts “hands-on” and learn from each other. The seminar offers participants a great opportunity to establish a network of supporting resources for risk assessments and engineering for manufacturing pharmaceutical compounds in their work setting.

Take Back To Your Job

• An introduction to ISPE's Risk-MaPP Baseline Guide and ts application
• A clear understanding of hazard, risk and exposure and how they affect each other
• Practical learning from case studies including engineering, risk approach, process design, operational procedures and operator training through presentations and workgroups
• Successful solutions to current containment issues
• A tool kit to help select risk controls and engineered solutions that balance product quality and operator protection – including an introduction of the Containment COP

• OEB determination at Boehringer Ingelheim
• GMP and containment
• Risk management

• Extreme OEL at high production volumes

• Three Case studies to be elaborated in four groups
  

• Case study 1: Containment for OSD manufacture
• Case study 2: Containment for sterile cytotoxics
• Case study 3: API manufacture

• Case study 1: Containment for OSD manufacture
• Case study 2: Containment for sterile cytotoxics
• Case study 3: API manufacture

• GMP vs. IH
• Containment isolator
• Containment RABS
• Case studies
  

• ISPE’s Risk-MaPP Baseline Guide
• Hazard vs. risk
• Science-based decision making
• When to dedicate or segregate

• Stay tuned for future session updates

• Pros and cons of high level containment valves
• Impact to utilities, dedusting and process infrastructure
• Design considerations dedusting system
• Example integrated project approach vendor/end use