How to Mitigate Microbials in Purified Water and WFI Water Systems: Theory and Practical Application Details Thoroughly Explained Clearly and Concisely


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This course is a comprehensive training on pharmaceutical water systems encompassing over 15 different course subject and modules. The modules include design, build, installation, validation, regulatory compliance, regulatory audit expectations, documentation expectations, modules on continuous electrodeionization (CEDI), ozone, reverse osmosis (RO), distillation methods, pure steam generation, pretreatment options, microbial mitigation and sanitization methods, raw water and sourced water criteria, instrumentation for both observational and compendial criteria, and automation expectations.

Microbial mitigation is one of the most important aspects for purification systems. This course emphasizes the mitigation of microbials in Purified Water and WFI water systems. Profiling microbials in pretreatment systems is a non-compendial exercise. There is a contentious debate about microbial counts in the pretreatment system and whether investigations should be conducted to find microbials considered part of the “bad bug” list. Profiling microbials in the pretreatment and whether this operation is warranted or not due to the new ISO-22519. How ISO-22519 applies to compendial compliance or not.

Modules will be given on WFI water systems produced by non-distilled means using a variety of purification modules to achieve WFI quality. Depiction of different production options for non-distilled WFI is will offered and analyzed. Additionally there will be an overview module on the Baseline Guide for Water and Steam Systems, the most comprehensive guide on pharmaceutical water and steam systems in existence.

Examples of modules to be given at the seminar:

  • Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry
  • Comparison of Hot water, Chemical, and Ozone Sanitization for Pharmaceutical Processes
  • Continuous/Electro Deionization (CEDI)
  • Instrumentation, Measurements, Testing of Source, Pretreatment, and Pharmaceutical Waters
  • Lessons Learned from and In-depth FDA Investigation
  • Microbial Issues and its Mitigation in Pharmaceutical Waters
  • Myths, Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems
  • OPEX and CAPEX The Actual Cost Pharmaceutical Water Systems
  • PAT (Process Analytical Technology): An FDA and Industry Effort
  • Possible ideas, approaches, and directions for future production, process, cGMP compliance, and critical utilities
  • Production of WFI Water Without Distillation - New Changes in the European Pharmacopeia
  • Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
  • Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems
  • Sustainability - The Reclaim, Recycle, Reuse and Reduction of Water in Biopharmaceutical Production
  • The Use of Statistical Process Control (SPC) and Exponentially Weighted Process Statistics (EWPS) for PAT in Pharmaceutical Water Systems
  • Understanding and Troubleshooting Pharmaceutical Water Systems
  • Validation of a Pharmaceutical Water System for the 21st Century
  • Water for Injection (WFI): A Changing Paradigm of Production Methods – USP Perspective
  • Water for Pharmaceutical Use / Water Purification Engineering

Learning Objectives:

  • You will learn and understand the following:
  • Pharmaceutical Water systems
  • The operations of a pharmaceutical water system
  • The basic chemistry involved in water purification
  • The options of choosing properly defined equipment for individual purification steps
  • The issues of microbial monitoring and sampling
  • The value of different sanitization methods used in pharmaceutical water systems
  • The difference of gram-negative and gram-positive bacteria and their influence in biofilm development
  • The configuration of CEDI, EDI, and Ion Exchange is removing ions from the water
  • The usage of microfiltration (MF), ultrafiltration (UF), and nanofiltration (NF)
  • All modules used in pharmaceutical water production from source water to finished product water supplied to production.
  • The different regulatory, pharmacopeial, and international regulatory issues associated with pharmaceutical water.
  • What lessons can be learned from a regulatory audit or investigation.
  • The usage of Statistical Process Control and Exponentially Weighted Process Statistics to monitor and control your water system long before it hits an action or alert limit.
  • The usage and production of non-distilled WFI.

Who will benefit:

Pharmaceutical, Over-the-Counter, Beauty, Nutraceutical, Biotechnology, and medical device industry professionals in engineering, critical utilities, technical competencies, maintenance, quality control, quality assurance, engineering management, global responsible production personnel.

DAY 01(8:30 AM - 4:30 PM)

8:30 AM- 8:59 AM Registration Meet & Greet.

9:00 AM- 10:00 AM

  • Seminar objectives review, expectations and scope.
  • Overview of subjects and time constraints
  • Explanation on the ad hoc quizzes at the end of each module

10:00 AM- 11:30 AM

  • Understanding and Troubleshooting Pharmaceutical Water Systems

11:30 AM- 12:00 PM

  • Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems

12:00 PM- 1:00 PM Lunch

1:00 PM- 2:00 PM

  • Source Water Microbial and TOC Destruction in Pretreatment Pharmaceutical Water Systems

2:00 PM- 3:00 PM

  • Continuous/Electro Deionization (CEDI)
  • Possible ideas, approaches, and directions for future production, process, cGMP compliance, and critical utilities

3:00 PM- 4:00 PM

  • Myths, Misconceptions, and Realities: The Legacy of Obsolete SOPs and Specifications in Modern Pharmaceutical Water Systems

4:00 PM- 4:30 PM

  • Sustainability - The Reclaim, Recycle, Reuse and Reduction of Water in Biopharmaceutical Production

DAY 02(8:30 AM - 4:30 PM)

8:30 AM- 8:59 AM Registration Meet & Greet.

9:00 AM- 10:00 AM

  • Comparison of Hot water, Chemical, and Ozone Sanitization for Pharmaceutical Processes

10:00 AM- 11:00 AM

  • Production of WFI Water Without Distillation - New Changes in the European Pharmacopeia
  • Water for Injection (WFI): A Changing Paradigm of Production Methods – USP Perspective

11:00 AM- 12:00 PM

  • Rapid Microbial Monitoring: Regulatory and Application Strategies for Pharmaceutical Water Systems
  • Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry

12:00 PM- 1:00 PM Lunch

1:00 PM- 2:00 PM

  • The Use of Statistical Process Control (SPC) and Exponentially Weighted Process Statistics (EWPS) for PAT in Pharmaceutical Water Systems
  • Validation of a Pharmaceutical Water System for the 21st Century

2:00 PM- 3:00 PM

  • PAT (Process Analytical Technology): An FDA and Industry Effort
  • OPEX and CAPEX - The Actual Cost Pharmaceutical Water Systems

3:00 PM- 4:00 PM

  • Lessons Learned from and In-depth FDA Investigation

4:00 PM- 4:30 PM

  • Q & A and wrap up
Seminar (Price/Register)
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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