ISPE Milan Conferences - Kereon AG

Containment Technology Forum
28-29 November 2005
Conference Leaders
Giorgio de Castiglioni, Pharmatech Srl, Italy
Johannes Rauschnabel, Robert Bosch GmbH, Germany
Programme
Conference Description
This Conference will discuss the latest developments in
the containment of potent compounds for the
manufacture of bulk active pharmaceutical ingredients
and the production of drugs in their final dosage form.
The challenges of complying with health and safety
requirements, current GMP demands and new developments
in engineering and methodology will all be
developed and discussed in detail.
Leading international speakers will provide a global
perspective of the regulatory expectations for
compliance with health and safety and GMP. Risk
evaluation professionals will discuss the development of
a practical and compliant risk assessment strategy.
A number of new, practical case studies will leverage
the experience of others to demonstrate the impact of
containment on the planning, designing and
construction of facilities. The successful validation of
facilities and equipment, as well as “state-of-the-art
advances” will also be featured.
Learning Objectives
At the conclusion of this conference, delegates will be able to:
• Gain an appraisal of current HSE issues
• Learn about the regulatory expectations for
containment
• Understand the implications of containment on
facility design and operation
• Discuss with peers the impact and importance of
current state-of-the-art facility and equipment
designs
• Follow projects from conception phase to production
• Experience the interface between containment and
aseptic requirements for clinical trials
• Discuss and share experiences with fellow regulatory
and industry speakers and delegates and get your
issues addressed in a unique environment
Who Should Attend
• All professionals working in the field of potent
compound containment
• Health and safety executives
• Project and production managers, operations
managers
• Quality assurance professionals and regulatory affairs
executives
Agenda
Monday, 28 November
10.00 - 10.15 Welcome and Introduction
Giorgio de Castiglioni, Pharmatech Srl, Italy
Johannes Rauschnabel, Robert Bosch GmbH, Germany
10.15 - 11.15 Containment Issues from Design to
Construction
Gerald Cerulli, Technip Biopharm, USA
Jean François Dulière, Technip France, France
Francesco Zinnamosca, Technip Italy, Italy
• Regulations in Europe and USA
• Methodology, process design
• Specification and equipment
• Examples
11.15 - 12.15 Solids Containment for Filter Dryers
Torsten Belger, Powder Systems Ltd., UK
• Problem areas with HAPI filter dryers
• Solutions for today's HAPI requirements
• Practical examples
• Total containment for small scale filter dryers
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