Industries: Pharma / BiotechSkin & Cosmetics

Water Purification Systems for Regulated Industries

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

Course Director: Richard Newmiller

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

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

Who Should Attend

This course is designed for Regulatory, Quality, Compliance, Validation, R&D, Clinical, Manufacturing, Engineering, Maintenance, and Management personnel who are functioning as inspectors, auditors, investigators, sample analyzers, operators, and end-users as well as those in a project team or project management roles.

This two-day program will provide you with the training needed to enhance your understanding of water systems in terms of design, construction, commissioning, maintenance, and operations to ensure compliance with International Standards Organization (ISO) Criteria, Food and Drug Administration (FDA) Regulations and Guidance, United States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopoeia (JP), Clinical and Laboratory Standards Institute (CLSI), the American Society for Testing and Materials (ASTM), Good Engineering Practice and others.

First Day

Introduction

  • Agenda review
  • Basic water chemistry
  • Allowable drinking water contaminates
  • Packaged water exercise

Classification of Water Purification Systems

  • Potable water and process water (filtered, softened, etc.)
  • Analytical water grades 1, 2, & 3
  • Reagent water types I, II, III & IV (sub-groups A, B & C)
  • Pharmacopeia water grades (Purified, Highly Purified, & Water for Injection)
  • Clean steam (condensate)

Governing Regulatory Agencies

  • Compendial specifications (USP, EP, & JP)
  • FDA and European GMPs
  • EPA, ASTM, CLSI, ISO, ICH, BS, WHO, ISPE, and others
  • Exercise

Unit Operations

  • Pretreatment component equipment and arrangement options based on feed water analysis
  • Methods to control turbidity, particulates, hardness, metals, organic, and microbiological impurities
  • Final treatment (reverse osmosis, vapor compression, single-effect and multiple-effect stills)
  • Sampling, cleaning and sanitization requirements
  • Energy/resource conservation measures

System Design Parameters

  • Point of use criteria: temperature, location, time-of-day, and demand (GPM & GPD)
  • Generation rate, storage capacity, peak demand limit, batched vs continuous operation, sanitization schedule, maintenance shutdowns
  • Localized systems: packaged water, single or multiple POU bench top units
  • Distributed systems: storage tanks (single, batched, secondary), distribution network (single pipe – one way flow, recirculating, hot loop, cold loop, POU temperature control, flushing and sanitization schemes, etc.)
  • Exercise

Distribution System Components

  • Materials of construction
  • Types of stainless steel
  • Sanitary and non-sanitary piping fittings
  • Valve types and selection criteria
  • Sample ports and steam coolers
  • Exercise

Recap, Questions and Answers

Second Day

Commissioning and Qualification

  • Plan development and flow chart with controls – observations, exceptions, and variances
  • Direct and in-direct impact assessment
  • The importance of as-built documentation – ETOP
  • Is the initial start-up commissioning?
  • Risk assessment, team approach with SMEs – identification, probability, and impact
  • Sampling plan – location, frequency and duration
  • Validate emergency maintenance during typical failures
  • Exercise

Operations and Maintenance

  • Accountability, SOP’s, and training
  • Preventative & predictive maintenance
  • Daily inspection checklist, trend reports, alarms
  • Cleaning, sanitization, rouging
  • Consumables replacement, yearly shut-down
  • Managing performance deviations and component failure (microbial limits, pH, distribution pump, vent filter, rupture disc, etc.)
  • Startup challenges (initial and post shut-down)
  • Exercise

Instrumentation Calibration

  • Identification of critical, non-critical, and informational instruments
  • Program set up and impact to operations
  • Required actions for out-of-spec “as found” conditions

Control and Monitoring System Performance

  • SCADA type systems, data historian, secure access
  • Control set points – range and tolerances
  • Alarms – alert, action, failure
  • Conductivity, temperature, flow rate, pressure, CFUs, etc.
  • Trend reports (analysis, problem identification, predictive value)
  • Exercise

Recap, Questions and Answers

Course Evaluation

Learning Objectives

Upon completion of this course, each participant will have a comprehensive overview and understanding of water systems and how they are selected, installed, commissioned, validated, operated, and maintained in a regulated environment. The course content will enable the participant to understand system design, analyze performance data, ask more informed questions, and challenge findings when communicating in a group setting on a broad variety of water issues. In addition, the regulatory agencies with a direct impact on the design and operation of both compendial and non-compendial systems will be presented.

Testimonials

"The course director was excellent. Not only did he display the knowledge to properly guide and teach the course, but his pace in presenting the materials was excellent. I never felt that the material was presented too fast or too slow. He was always open to questions and encouraged them which was fantastic because that engagement increased my understanding of the material." Shervin G., Regulatory Compliance Manager, Thermo Fisher
"The Course Director was awesome. The humor that he added was nice, and his knowledge of the subject made this course easier to understand, as there is a lot of information." Kevin S., Operations Manager, Illumination Technologies