Water Purification Systems for Regulated Industries - Design, Chemistry and Validation

The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications.

The course is designed to provide the attendee with a practical understanding of the following topics:

• Basic water chemistry
• Water quality selection criteria
• EPA, EU, and WHO drinking water standards
• The governing regulatory agencies with direct impact on water systems
• Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups)
• Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam)
• Pretreatment component equipment – selection and operating principals
• Final treatment options (reverse osmosis, vapor compression, single-effect and multiple-effect stills)
• Opportunities for energy and water resource conservation
• Point of use criteria such as temperature, location, time-of-day, and demand (GPM & GPD)
• System design including materials of construction, generation, storage and distribution options
• Trend reports (analysis, problem identification, predictive value)
• Control systems, data historian, secure access, set points and alarms
• Managing performance deviations and component failure
• Direct and in-direct impact analysis
• Quality by design including risk assessment
• Instrument calibration for critical, non-critical, and informational only devices
• Maintenance impacts to system performance, reliability, and validation
• The importance of as-built documentation – user and field directed changes

Richard F. Newmiller has over 20 years of Pharmaceutical Industry experience. Presently he is a Senior Engineering Consultant supplying project management services with a unique background that includes corporate, contractor, consultant and owner perspectives.

Rich has provided Engineering, consulting, operations, and maintenance expertise as an employee for a variety of manufacturing and research organizations including Merck, SmithKline Beckman (now Glaxo SmithKline), Centocor (now Johnson & Johnson) and Wyeth (now Pfizer) where he was Senior Director, Project Engineering, Global Engineering Services.

He has executed hundreds of Pharma projects with a value in excess of $2 billion. Responsibilities included obtaining funding, contractor selection, design, engineering, start-up, commissioning, validation and assisting with establishment and product licensing. Those projects produced products that ranged from topicals, liquids, and solid dosage to injectables supporting OTC, diagnostic, biological, and pharmaceutical operations in the US, Canada, Puerto Rico, England and Holland. Rich received his B.S. in Mechanical Engineering from Drexel University, and an MBA from Temple University; he earned his Professional Engineering (PE) license in Pennsylvania.

Mr. Newmiller currently teaches:

Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment

Pharmaceutical Water System Design, Chemistry and Validation