A Strategic Approach to Containment Systems

An Integrated Process From Concept To Use

Session 506
Technology Track

There are a myriad of containment solutions available to Pharmaceutical Manufacturers, but there are times when the range of technologies and when to apply a particular solution is not completely understood. The purpose of this session is to provide a broad understanding of the solutions available, how to confirm the claims made by the containment supplier, and to delve deeper into the stated performance of a given solution through the sharing actual industry experiences and experts. This includes what to do when the installation is complete and you need to operate, demonstrate conformance, clean, maintain and repair the system when you are processing a potent or highly hazardous product, or if an upset condition were to occur.

Session Description

This session will provide an overview of containment methodologies by process and include a hierarchy of containment strategy. Challenges will be reviewed for transfers between various pieces of equipment, cleaning, maintenance, Industrial Hygiene Validation and sampling, process sampling and upset conditions. Combining technologies to enhance containment applications will also be discussed. Case Studies and methodologies will be presented by subject matter experts from Corden Pharma Colorado, IES, and SafeBridge.

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

Evaluate the production process as related to potential Occupational Exposure Risks
Determine the most applicable containment technology for your specific process
Understand the IH monitoring process and the application of the recently updated SMEPAC Guidelines

Leaders

Speakers

Jeff Campie, USA
Richard Forsyth, Senior Consultant, Hyde Engineering + Consulting, USA
Nigel Hamilton, Global Quality, Strategy and Process Excellence, Sanofi Aventis, United Kingdom
Aisling Horan, Validation Scientist, Alkermes Plc, Ireland
Edwin Melendez, Principle Consultant, Parexel, USA
Mark O'Reilly, Director Engineering, Alkermes Pharma Ireland Ltd, Ireland
Kimberly Ray, A. Director Project Mgmt, Oso Biopharmaceuticals Mfg LLC, USA
Julian Wilkins, Vice President, PharmaConsult US Inc, USA
Paul Wreglesworth, Independent Consultant, United Kingdom

Who Should Attend

Manufacturing / Operations from International Pharmaceutical Manufacturers, Contract Manufacturers and Formulators, Generic Pharmaceutical Manufacturers
Environment Health and Safety professionals
Service Providers
Suppliers
Regulators

Communities of Practice Members that will Benefit

API
Containment

More information on ISPE's Communities of Practice