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CONFERENCEPROGRAM2016 PREMIUM EXHIBITORS

2016 PARTNERS

2016 COCKTAILS SPONSOR 2016 WIFI SPONSOR

2016 LANYARDS SPONSOR

2016 LUNCH SPONSOR

2016 DINNER SPONSOR

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2016 WIFI SPONSOR

NETWORK NAME: UPW MICRO/PHARMA

NETWORK KEY: aquafine

Aquafine is the leading provider of innovative industrial fluid treatments using ultraviolet (UV) technology. Developing high-performance, eco-friendly products for today’s most demanding UV applications. Whether disinfection, total oxidizable carbon (TOC) reduction, chlorine and chloramines destruction, ozone destruction, or advanced oxidation processes (AOP), Aquafine’s products provide effective UV treatment.

With thousands of installations worldwide, Aquafine recognizes that water impurities, compliance to state, federal and international regulations, and equipment reliability are often the most important factors, and they work with customers to create a strategic partnership. Aquafine continues leading the way to safer, more efficient UV treatment solutions.

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A MESSAGE FROM THEORGANIZERS

UPW Pharma 2016 brings together leading experts in pharmaceutical water treatment to discuss best practices, GMP, process breakthroughs, misconceptions and regulatory developments.

The pharmaceutical water industry is known for being faithful to its traditions. UPW Pharma 2016 will explore how the Pharmaceutical Water System Life Cycle could be optimized while not straying from these traditions. We are delighted to have you join us in Austin to discover and discuss how pharma-ceutical water systems could become more efficient, cost-effective, conserve more water, embrace innovations and still maintain compliance.

Thanks to the devotion and support of the UPW Pharma 2016 Advisory Committee, this year’s event features extended, in-depth presentations by industry experts and devotes an entire session to the end-user perspective.

We hope you use the new format to learn from each other, engage in meaningful discussions and, together with other industry stakeholders, discover innovative solutions to address an industry in transition.

Together with the UPW Pharma Sponsors, we are very excited to welcome you to experience the flavors and sounds of Austin, a city known for its innovative culture, vibrant music and exceptional cuisine.

Enjoy UPW Pharma 2016

-Global Water Intelligence

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2016 ADVISORY COMMITTEE

Anthony Bevilacqua, METTLER TOLEDO-ThortonDr. Anthony Bevilacqua is the Head of Research and Development at Mettler-Toledo Thornton. He earned a doctorate in Analytical and Physical Chemistry from Tufts University. Anthony was a Process Development Scientist at Mobil Solar Energy developing of solar energy cells and panels. He has been at Thornton since 1994, leading them in several areas of R&D, including improved high temperature conductiv-ity measurements, the impact of CO2 on pure water, use of ultrapure water (UPW) as a conductivity solution standard, development of digital sensors, and the expansion of analytical parameters (conductivity, TOC, ozone, sodium, and silica).

Nissan Cohen, Start-up Business DevelopmentNissan has over 40 years experience high purity, ultrapure, and WFI water systems in pharmaceuticals, biotechnology, and semiconductors. He is a recognized world-wide expert in all high purity and ultrapure water systems with exceptional knowledge in advanced oxidation, TOC, UV, Ion exchange and ozonation systems. He has written over 35 technical and peer-reviewed papers in Semiconductor International, Ultrapure Water, A2C2, Microcontamination, Pharmaceutical Engineering, and Pharmaceutical Technology.

Elizabeth Dunn, ProPharma GroupElizabeth Dunn is a quality professional with 30 years of experience in the Pharma and Biotech industries. She has served in various roles in Validation, Quality Assurance, and Quality Control for both operating companies (Pfizer, Gilead, Amgen, BI, Hospira) and consulting companies (JH Services, Dunn GxP Services). Her education includes a Bachelor’s degree in Biology and an MBA. In November of 2013, she joined ProPharma Group as a Principal Technical Consultant.

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2016 ADVISORY COMMITTEE

Nik Krpan, Cheme EngineeringNik Krpan is president of Cheme Engineering Inc. His areas of expertise include design, project management, commissioning, validation, and team building. His water treatment specialties include water purification and distribution systems, purified water, WFI, pure steam (subject matter expert), process systems, CIP / SIP, and cross flow filtration. He holds a M.A.Sc., P. Engineering from the University of Waterloo.

Joseph Manfredi, GMP SystemsJoseph Manfredi is president of GMP Systems. He is widely respected for his expertise in pharmaceutical water and has spent more than 30 years designing systems, overseeing fabrication and installation, trouble shooting, training and providing consulting services for major pharma-ceutical manufacturers. Additionally, Mr. Manfredi has taught as part of the graduate faculty at New Jersey Institute of Technology in the Pharmaceutical Engineering Masters of Science Program.

T.C. Soli, Soli Pharma Solutions, Inc.Teri C. “T.C.” Soli, PhD, has lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has more than 34 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. He is in his third 5-year term on USP Expert Committees responsible for pharmaceutical water, is the primary author of USP’s Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted worldwide.

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REGISTRATION DESK

Austin Southpark

UPW PHARMA 2016

OMNI SOUTHPARK MAP

SUNROOM

OMNI A

OMNI B

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OMNI SOUTHPARK MAP

EXHIBIT HALL

Austin Southpark

REGISTRATION DESK

OMNI C OMNI D

OMNI E + F

PLENARY ROOM+

ULTRAPUREWATER STRAND

WATER MANAGEMENT

STRAND

PHARMAROUNDTABLES

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Ultrapure is an online resource that focuses on technologies, trends and troubleshooting for users of high purity and industrial water and wastewater treatment systems. Formerly published as the bi-monthly titles Ultrapure Water Journal and Industrial Water Treatment Magazine, Ultrapure unites the two publications, providing weekly updates with a continued focus on high quality, high value technical articles from industry experts, covering utility, process, and domestic and wastewater applications.

Learn more at www.ultrapurewater.com

ULTRAPURE MASTERING THEINDUSTRIAL WATER CYCLE

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AGENDA: DAY ONECONFERENCE CENTER / AMPHITHEATER

Topics covered during this presentation:

• Trends in water system maintenance• Design solutions and best practices• Connecting water systems to the right equipment• System monitoring and performance measurements• System validation

Joe Manfredi, GMP SystemsDina Manfredi, GMP SystemsDan Obercon, GMP Systems

7:00-8:00 BREAKFAST IN EXHIBIT HALL

8:00-8:30 KEYNOTE ADDRESSPhilip Sumner, Pfizer

8:30-10:30 SESSION 1: COMPENDIAL WATER SYSTEM DESIGN AND OPERATION

Optimizing pharmaceutical water system life cycle. This keynote address will explore how pharmaceutical water systems could become more efficient, cost-effective, conserve more water and maintain compliance.

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10:30-11:00

11:00-12:30

12:30-1:30

SPONSORED BY

LUNCH IN EXHIBIT HALL

AGENDA: DAY ONECONFERENCE CENTER / AMPHITHEATER

ROUNDTABLES SESSIONS IN SOUTHPARK

The UPW Pharma Roundtables session is a platform to exchange ideas and insights and to engage with delegates in a slightly more informal way.

Format: The session will last for 1.5 hours. Each roundtable host will lead 2 x 40-minute discussion groups and engage with delegates. While the roundtable host will remain on the same table, delegates will have a chance to rotate once and participate in two different roundtable discussions. 1. The driving force of innovations and upgrades of pharmaceutical water systems - Is there one? - Nik Krpan, Cheme Engineering 2. How to engineer bugs out of your system - Joe Manfredi, GMP Systems3. Microbial monitoring - Common misconceptions - T.C. Soli, Soli Pharma Solutions, Inc.4. RO brine minimization - Tim Kirk, P.E., Avista Technologies

COFFEE BREAK

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1:30-2:30 SESSION 2: EFFICIENT WATER PRODUCTION, CONSERVATION AND REUSE

Conservation and microbial quality of the water: Be careful what you ask for

There are many ways of conserving water and making and using it efficiently, but it almost always has a detrimental impact on the microbial quality of the water if certain precautions and efficiently sanitizable unit operations are not used.

T.C. Soli, Soli Pharma Solutions, Inc.

2:30-3:30

3:30-4:00

Water sustainability in the pharmaceutical industry

Topics covered during this presentation:

A Case Study: water recovery/reuse opportunity assessment at a vaccine manufacturing facility

Ed Helmig, AECOM

COFFEE BREAK

AGENDA: DAY ONECONFERENCE CENTER / AMPHITHEATER

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4:00-4:30 SESSION 3: MICROBIAL MONITORING

Rapid micro methods in pharma and the reasons for slow uptake

T.C. Soli, Soli Pharma Solutions, Inc.

4:30-5:00

5:00-5:30

Achieving accurate, effective, manually collected water sample USP 645 conductivity-stage 1 testing results in the laboratory

Richard Godec, GE Analytical Instruments

Optical-based rapid microbial detection technology

The technology under discussion is an optics based detector for singly counting microbial cells and differentiating them from inert particles by measuring intrinsic fluorescence from metabolites in microbial cells. Real time detection of bioburden by optics is in real time which could be beneficial for process control in treated water facilities.

Anthony Bevilacqua, METTLER TOLEDO-Thornton

AGENDA: DAY ONECONFERENCE CENTER / AMPHITHEATER

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5:30-7:00 COCKTAILS RECEPTION

SPONSORED BY

Diverse corporations in 170 countries look to Nalco Water, an Ecolab company, to deliver customized solutions and expert, onsite service. Harnessing innovative water, hygiene and process technologies and services, we partner with our customers to minimize their water consumption, maximize their results and optimize their total cost of operation.

NALCO.ECOLAB.COM

Dinner will be held off-site at Easy Tiger. This restaurant in historic downtown Austin features German style cuisine, beer garden and craft beers.

Shuttle buses will arrive at the Omni Hotel valet area immediately following the day one Cocktails Reception.

SPONSORED BY

7:00-9:00 DINNER

DETAILS

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AGENDA: DAY TWO

8:30-9:10

7:00-8:30

SESSION 4: DISTILLATION WORKSHOPVapor compression distillation: an option for the production of purified and highly purified pharmaceutical waters

Sharif Disi, MECO

9:10-9:25

9:25-10:30

DISCUSSION

CONFERENCE CENTER / AMPHITHEATER

BREAKFAST IN EXHIBIT HALL

SESSION 5: PROACTIVE WATER SYSTEM MANAGEMENT

Water system risk assessment

The role of risk assessment in the life cycle of compendial water systems will be examined, and appropriate risk assessment methods will be overviewed. The FMECA method will be examined in detail, and several case studies will be presented, followed by group exercise risk assessments to be discussed and debated.

Nik Krpan, Cheme Engineering

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11:00-11:30

Risk based approach to validation for critical utilities

Topics covered during this presentation:

• Risk based qualification – Risk based qualification of manufacturing systems by focusing qualification activities and quality oversight on the aspects of manufacturing systems with impact to product quality and patient safety

• System qualification lifecycle – Outline the lifecycle for qualifica-tion of manufacturing systems, consisting of plan, design, build and test, operate and maintain, and decommission phases

• Installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) requirements for EFU (equipment facilities utilities) water systems

Amit Syal, Genentech, Inc.

AGENDA: DAY TWOCONFERENCE CENTER / AMPHITHEATER

SESSION 6: END-USER PERSPECTIVE

10:30-11:00 COFFEE BREAK

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11:30-12:00

1:00-2:00

QC perspective on pharmaceutical waterTopics covered during this presentation:

• Importance of appropriate alert level• Risk assessments consideration

Gurpreet Ganda, Genentech, Inc.

UPW regulatory history and future regulatory challengesTopics covered during this presentation:

Key Changes: 1980s through today• Pyrogens:Introduction of LAL test• Heavy metals• TOC• Conductivity• RO

• Generation systems• Environmental issues; Sustainability• Controlling organics• Desalination

Elizabeth Dunn, ProPharma Group

SESSION 6: END-USER PERSPECTIVE (cont.)

SESSION 7: REGULATIONS AND GUIDELINES UPDATE

AGENDA: DAY TWOCONFERENCE CENTER / AMPHITHEATER

12:00-1:00 LUNCH BREAK IN EXHIBIT HALL

• Rouge• Biofilms• Current and future • Regulatory challenges

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2:00-3:00

Compendial history and upcoming changes for WFI and sterile WFITopics covered during this presentation:

• Sterile water for injection harmonization – Current actions at USP and EP• Change in allowable method of production by EP and implications• Impact of USP elemental impurities on pharmaceutical waters• Proposal to delete nitrates testing in EP and other regions

Anthony Bevilacqua, METTLER TOLEDO-Thornton

SESSION 7: REGULATIONS AND GUIDELINES UPDATE (cont.)

AGENDA: DAY TWOCONFERENCE CENTER / AMPHITHEATER

CONFERENCE CONCLUDES

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EXHIBITOR FLOORPLAN

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BWT Pharma & Biotech Georg Fischer

B&D Plastics LLC

3M

ChemTrace

Nalco Water, an Ecolab Company

Levitronix

Neotech Aqua Solutions

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Asahi America

Gemu Valves

Elemental Scientific

Particle Measuring Systems

Suez Environnement

Ovivo

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Air Liquide - Balazs NanoAnalysis

Evoqua Water Technologies

Kanomax FMT

Heateflex

ChemWest

GE Analytical Instruments

Plast-O-Matic

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SUNROOM EXHIBITOR FLOORPLAN

Watts Water Technologies

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Kurita

Lighthouse Worldwide Solutions

Pacific Ozone

Ultrapure Water

Azbil BioVigilant Swan Analytical Instruments

Mycometer

Harrington Industrial Plastics

Organo Corporation

Prince Rubber & Plastics Co., Inc.

Heraeus

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2016 PREMIUM SPONSORS

3M Membranes Business Unit is a leading expert in manufacturing and developing membranes and modules for ultrafiltration and dissolved gas control applications.3M™ Liqui-Cel™ Membrane Contactors are compact devices that rapidly strip dissolved gases from liquids without chemicals. These high performance devices are installed in-line to improve water quality and fluid process efficiency.3M™ Liqui-Flux™ ultrafiltration modules take advantage of a pressure-driven out flow design and operate in dead-end or cross-flow mode. With over 90 m2 of membrane surface area and various port configuration options these modules couple flexibility with the durability of 3M membrane for reliable and sustained performance.

Asahi/America offers a wide selection of thermoplastic piping systems and components for projects ranging from ultrapure water applications to water treatment and chemical feed lines. Headquartered in Lawrence, MA, Asahi/America domestically manufactures custom piping components and maintains a large inventory capable of supplying multi-million dollar projects.Asahi/America’s offering includes the Purad® PVDF high purity piping system, which is manufactured to the most stringent quality and purity standards. Asahi/America’s Poly-Flo® and Chem Proline® systems are ideal solutions for water treatment applications. We also maintain an extensive fleet of welding equipment to support large projects across the country.

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2016 PREMIUM SPONSORS

Evoqua Water Technologies offers the experience, innovation and deep knowledge that your production processes require to meet the stringent demands of the microelectronics and solar industries. Evoqua’s water solutions will help you meet your requirements for regulatory compliance, lifecycle cost and UPW quality. We provide cutting edge solutions for waterrecycle/reuse incorporating the latest emerging technologies. Water management answers from Evoqua prove their worth daily in:• Semiconductors Fabs• Disc Drive Manufacturing• University Nano Technology

GEMÜ Valves is a leading world-wide manufacturer of high quality valves, measurement and control systems. GEMÜ’s products are well known for their modular design, high performance, and superior quality. We strive to consistently provide a level of service exceeding the expectations of our customers. Every inquiry and order is carefully considered so the customer can be offered the most suitable GEMÜ product to match their requirements. GEMÜ’s overriding philosophy is to ensure each and every customer contact is a quality experience. GEMÜ is committed to the pursuit of quality and excellence in the development, production and manufacturing of our products.

Harrington Industrial Plastics is the country’s largest distributor of industrial plastic piping serving all industries with corrosive and high-purity applications. Harrington carries a complete line of piping products and accessories, and particularly noted for its technically trained sales staff.There are now over 50 strategically located branches throughout the continental U.S., and Hawaii. These facilities house all the components for a complete system such as piping, tubing, hose, tanks, grating, filtration, pumps, and instrumentation. A Harrington representative is available to you 24 hours a day, 7 days a week. To reach your local branch call (800) 213-4528.

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2016 PREMIUM SPONSORS

Heraeus Quartz is a market and technology leader in the production of high-purity quartz materials. We specialize in the development and manufacturing of both high purity quartz and synthetic fused silica for the microlithography, optics, semiconductor and lamp industries. We work closely with our customers to produce mainly synthetic fused materials needed for general production as well as custom materials. Typical products used in the disinfection market would include both undoped and doped tubing for lamps and sleeves along with plate and rod materials.

MECO has been world leaders in water purification technology since 1939. And we hold the patents to prove it. We introduced the vapor compression desalination process for seawater in 1939. We developed new technology that allows the U.S. Army to make fresh water from contaminated water in combat zones. Our systems produce pharmaceutical-grade water for use in injectable drugs and the water that gives soda its pop.Our product is pure water. But our business is solutions. We engineer need-specific systems that take everything from flow rate to climate into account. We can do that because we’re experienced, innovative water purification specialists.

OVIVO is a global leader in sustainable water treatment solutions for industrial, municipal water and wastewater treatment, spanning all industries worldwide. The company’s passion to create value in water is executed through the design, installation and commissioning of highly sophisticated water treatment systems, providing the best solutions to treat and recycle water at the lowest energy cost. While the world acknowledges that it is facing a clean water crisis, the demand for water is ever increasing. OVIVO develops and provides high performance technologies to serve the semiconductor industry’s use of water and has had great success in meeting the most stringent TOC requirements (< 0.3 ppb).

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2016 PREMIUM SPONSORS

Samsung Austin Semiconductor (SAS) is one of the most advanced semiconductor manu-facturing facilities in the world. It is also home to Samsung Austin Research and Development Center (SARC) - a world-class R&D Center which develops high-performance, low-power, complex CPU and System IP architecture and designs for Samsung’s System LSI division. SAS produces digital LSI logic components for tablets, smart phones, and other mobile de-vices. With over 2600 employees and 2.3 million square feet of space, SAS is designing and producing a full range of design rule devices. Since 1997, SAS has invested approximately $15 billion in its Austin, Texas, campus, making it one of the largest direct foreign investments in United States history.

Watts Water Technologies, Inc. has a long history: The Company was founded by Joseph E. Watts in 1874 under the name Watts Regulator Company. Watts Regulator started as a small machine shop supplying parts to the New England textile mills, including manufacturing pressure-reducing and relief valves to ensure the safe operation of water heaters and boilers. We have a global presence, from our corporate headquarters in North Andover, MA, to key business subsidiaries in the Americas, EMEA, and Asia-Pacific. In addition, the Watts Water Technologies, Inc. executive team brings together a significant depth and breadth of management experience.

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