Event: Session: WASHINGTON 2010 CONFERENCE E04 - Critical Utilities: Best Practices in Managing Risk and Cost in Water, Steam and Process Gas Systems Session Leader: Dates: Location: Andrew Collentro, Brian Severson Monday and Tuesday 7-8 June 2010 Washington, DC Monday, 7 June Start Time End Time Presentation Title Speaker (Speaker and Leader Breakfast 7:00) Breakfast Welcome and Introduction including COP information; set up for the discussion groups later in the day Water Conservation Case Study (J&J) Networking Break Case Study (Genentech) Collentro Severson Khadra 7:30 9:00 9:00 9:15 9:15 10:00 10:30 10:00 10:30 11:15 11:15 12:00 Mehrotra New Developments: Issues and Significance of Advanced Membrane Technologies Currently Under Development This presentation will focus on the implications of new developments in fouling-resistant, ultrafiltration and reverse osmosis desalination membranes including the mechanisms of fouling resistance imparted by coatings on ultrafiltration membranes, and implications for long term maintenance, cost and filtrate water flux. High flux membrane technologies for reverse osmosis-based desalination will be presented along with implications on cost and system energy savings and the impact of both technologies on candidate applications. 12:00 13:00 13:00 13:45 Lunch USA: Risk-Based Approach to GMPs for Critical Utilities 13:45 14:30 Regulatory Q&A 14:30 15:00 15:00 15:45 Networking Break Cohen Economic Comparison of Hot Water and Ozone Sanitization in Pharmaceutical Water Systems - Investment capital - Major changes in FDA interpretation - How to get out of the traditional QC/QA Quagmire - Operational characteristics and costs - Maintenance costs - Mandated tests comparison of TOC, Conductivity, and Microbial - Attendees should be all facilities and engineering personnel involved with USP and WFI water systems. 15:45 16:45 Discussion Groups on Cost Reduction Topics - Water - Energy - Process Gases 16:45 17:00 17:00 Report out from Discussion Groups Seminar Adjourns, Reception in the Exhibit Hall Shanks Joseph McGinnis, FDA Joseph McGinnis, FDA Collentro Severson Tuesday, 8 June Start Time 7:30 9:00 End Time 9:00 9:05 Presentation Title 9:05 10:00 Federal Climate and Energy Initiatives - Implications for the Pharmaceutical Industry - Mandatory Greenhouse Gas Reporting Rule - Energy Performance Scales for Pharmaceutical Plants - ENERGY STAR and Other Federal Energy and Climate Voluntary Programs. 10:00 10:30 10:30 11:15 Networking Break H. van Ormer Overcoming the Air Myths with Facts – Bringing Cash to the Bottom Line This presentation includes an overview of the compressed air myths that hinder plant personnel from looking for and implementing successful compressed air energy reduction programs including leak identification, quantification, accurate reporting to management, and common demand side compressed air energy savings opportunities. It sill not address supply side issues such as types of compressors, dryers, installation, drive systems, etc. 11:15 12:00 S. van Ormer Uncovering the On-site Generation of Inert Gases Inert gases such as nitrogen have typically been purchased for use in pharmaceutical manufacturing processes in bulk or high-pressure storage bottles from gas suppliers. New equipment technologies have been introduced which could make on-site generation more appealing for many users. This presentation will investigate the on-site generation of nitrogen, the technologies associated with on-sire generation, the potential opportunities for cost reduction associated with on-site generation, and how various technologies can be used for generation of other inert gases as well as the pitfalls of generating volatile gases such as oxygen oxygen. 12:00 13:00 13:00 13:45 Lunch The New Guide - What's New and How it Can Contribute to Cost Saving Measures Learn from the work of more than 50 experts on the latest industry practices to design, maintain, and trouble shoot water and steam systems. Significant changes include new chapters on rouge, laboratory water, and bacterial challenges as well as new water and energy conservation examples. 13:45 14:30 Analysis of Water Sampling - Regulatory Requirements - Validation Sampling Phases 1,2,3 - At Phase 2, regular sampling program - a RA to develop sampling and monitoring program This presentation will focus on Pfizer's approach at Phase 2 and adjustments to reach confidence level. Data will consider micro with a cross check of chemistry. Total Organic Carbon (TOC) online monitoring with its opportunities, limitations and conductivity toward potential savings that can be realized. 14:30 15:00 15:00 15:45 Networking Break Rouge Survey Results and Implications - There has been a survey conducted over the last year and a half - Survey results are being compiled and there is some controversy over the apparent results 15:45 16:30 Case Studies in De-Rouging - Strategies used around the world Augustine 16:30 17:00 17:00 Rouge Discussion and Open Q&A Seminar Adjourns All Speakers Breakfast in Exhibit Hall Welcome to Day Two **Please Note that Agendas are Subject to Change** Speaker Collentro Severson Tunnessen Sipe Vishton Lewis