Pharmaceutical Water – System Design, Operation and Validation

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A 2020 Overview – Production Methods for Bulk USP & EP Water for Injection


Historically the European Pharmacopeia (EP) limited the production of “Water for Injection” (Bulk) to distillation.  The United States Pharmacopeia (USP) limited production of “Water for Injection” to distillation or reverse osmosis (which was infrequently used). Several years ago, USP changed the production technique to a “… process that is equivalent or superior to distillation in the removal of chemicals and microorganisms”. As part of harmonization of the two pharmacopeias, the EP Water for Injection Monograph was revised to include non-distillation-based production methods. This presentation is structured in three sections:


Part 1 – Bulk WFI Compendial Water Requirements

    • Inorganic, organic, bacteria and bacterial endotoxin (BET) measurement and limits
    • System feed water requirements
    • Types of impurities with range of concentration in feed water supplies


Part II – Representative Methods for Producing and Delivering WFI with Storage Options

    • Pretreatment, Multiple Effect Distillation (MES) and storage options
    • Pretreatment, Vapor Compression (VC) distillation and storage options
    • Pretreatment, non-circulating non-hot-water-sanitizable reverse osmosis (RO), post RO ion removal, final filtration and storage options
    • Pretreatment, recirculating hot water sanitizable RO system, post RO ion removal, final filtration and storage options.
    • Pretreatment, ion exchange, final hollow fiber ultrafiltration and storage options.


Part III – Critical Factors to Consider when Selecting a Method for WFI Production and Storage

    • Technical evaluation for application
    • WFI storage and distribution temperature
    • WFI storage and distribution microbial control – Dissolved ozone
    • System maintenance considerations
    • System monitoring considerations
    • Capital and operating costs
    • Risk


Top Ten Reasons to Attend:

  1. Chemical and microbial requirements for bulk WFI
  2. Impurities in feed water supplies and impact on selection of production method for WFI
  3. Overview of Multiple Effect Distillation
  4. Overview of Vapor Compression Distillation units
  5. WFI production using RO and ion polishing
  6. Hot water sanitizable recirculating RO units for production of WFI
  7. Microbial control in storage and distribution systems using dissolved ozone
  8. Selection of method for producing WFI based on application
  9. The importance of system maintenance and monitoring for WFI systems
  10. Risk factors associated with different methods of WFI production


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Did you know that you can earn 1.5 graduate credits hours to Temple University’s RAQA Graduate Program by attending a KENX Conference or Virtual Conference? For more information email howard.wilensky@kenx.org.


William V. Collentro

Adjunct Associate Professor, RAQA; RAQA Graduate Program; Temple University School of Pharmacy

With forty+ years of experience, William V. Collentro is a renowned expert in high purity water systems, filtration, and water for injection. In 1998, he wrote Pharmaceutical Water: System Design, Operation, and Validation, with a second edition in 2010, which is still regarded as the authoritative text on life science water issues. He holds four patents on purification systems (two U.S. and two international). A highly popular and provocative speaker on water topics at national forums (including FDA, the International Water Conference, and the Parenteral Drug Association), he has authored over 100 papers, many pioneering new insights and processes. He is the founder and senior consultant for Pharmaceutical Water Specialists in Plymouth, MA, and teaches High Purity Water Systems for the Temple University’s RAQA graduate program.

Today he will address the controversial subject of Non-Distillation Production of USP and EP Water for Injection, and looks forward to comments, questions, and debates from participants.