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