Improving Pharmaceutical Water Systems: A Green Approach to Water Savings

Evolution and Optimization of a High Purity Water System for Bioprocess Operations

Session 502
Facilities and Equipment Track

This session is intended to assist those responsible for conservation, environmental compliance, cost reduction, system design, and most aspects of plant operations. Reducing waste adds value to the bottom line while demonstrating environmental responsibility. The technologies are familiar to operations personnel and not new or unique. Hence, implementation is simple and straight forward. The return on investment is rapid and the “greening” of most facilities can be greatly enhanced without system downtime or other undesirable consequences.

Session Description

High purity water systems are a common feature in bioprocess clinical and manufacturing operations. To insure reliable, compliant, and cost-effective supply of water requires continuous engineering and quality assurance oversight. This session will discuss the evolution and optimization of a high purity water system supporting a bioprocess clinical trial pilot plant. Shared best practices and lessons learned are illustrated by case studies that include new technology and PAT upgrades, as well as innovative solutions to operational deficiencies.

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

Understand current challenges in supporting high purity water systems
Benchmark their high purity water operations with others in the industry
Describe new and emerging technologies, including PAT, used to improve high purity water systems
Learn compliance lessons that can be applied to their facility support
Become familiar with the most common methods used for water system reclamation
Discuss levels of reclamation possible and the costs associated with maximizing the percent reclaimed, including the costs and pay-back that could be anticipated
Learn about technologies associated with facility waste water treatment will also be discussed relative to minimizing the risk associated with discharge containing active drug substances

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
Service Providers
Suppliers
Regulators

Communities of Practice Members that will Benefit

API
Biotechnology
Critical Utilities
Engineering Standards Benchmarking
Operations Management
Process/Product Development
Project Management
Sterile Products Processing
Sustainable Facilities

More information on ISPE's Communities of Practice