Microbial Issues and its Mitigation in Pharmaceutical Waters

Why Should You Attend:

Understanding microbial growth and mitigation is extremely important when operating a pharmaceutical water system.

Compliance to Pharmacopeial mandates in mandatory, you will learn where to sample for microbials and why.

Understanding the relationship between possible microbial growth and different production equipment will better enhance your maintenance activities.

Microbial proliferation is a function of both temperature and nutrients, understanding this relationship will help in mitigation strategies.

Sanitization methods are discussed in great detail to enhance the chances of having a pristine water system with rare remediation instances.

This webinar is on microbials and their mitigation in pharmaceutical water systems.

Microbials are mandated to be measured for every point of use (POU) used in pharmaceutical production. Microbials, as determined by traditional inoculation and incubation, delineate acceptance or rejection of pharmaceutical water for production and usage.

Microbes have different states as they develop into biofilms. Mitigation of these single cells or colonies is via sanitization methods. Sanitization methods can be heat, ozone, chemical, filtration, UV etc.. Each has its advantages and disadvantages. Choosing the proper microbial mitigation system is paramount in having a pristine water system devoid of microbial contamination.

Current inoculation and incubation techniques may only show viable culturable microbes. It has been estimated that less than 1 percent of all microbials in water are viable and culturable. Meaning most gram-negative bacteria in water are unculturable in R2A media. Only culturable viable bacteria are counted after incubation. However, all Pharmaceutical water systems regardless of which pharmacopeia is enforced, must adhere to stringent values of colony forming units (CFUs) per ml.

Areas Covered in the Webinar:

• Biofilm development
• Stages of microbial growth, exploration, sessile, and planktonic
• Gram-positive and gram-negative bacteria
• The FDA’s “Bad Bug” list and why it is used improperly
• Sanitization methods utility and efficacy
• Destruction of microbials by different sanitization methods
• Microbial sampling, enumeration, and incubation
• Importance of correct sampling of microbials
• Rapid Microbial Monitoring overview

Who Will Benefit:

Pharmaceutical personnel in:

• Engineering, water systems, critical utilities, QA/QC, microbiologists, micro technicians, operations, production, and engineering management

Nissan Cohen
Owner, Biopharmaceutical Water Doc

A recognized worldwide expert, with over 40 years’ experience, in high purity, ultrapure, reclaim and recycle water systems, and Total Organic Carbon (TOC) with profound expertise in instrumentation, automation, and organic contamination oxidation systems using ozone, UV, ion exchange and catalysts. Accomplished writer of over 35 technical articles published in Ultrapure Water, A2C2, Pharmaceutical Technology, Pharmaceutical Engineering, Semiconductor International, The Journal of the Institute of Environmental Sciences and Technology.

Co-Chairman, Contributing author and Chapter Leader of International Society for Pharmaceutical Engineering’s (ISPE) “Baseline Guide for Pharmaceutical Water and Steam Systems”. Revisions 1, 2, and 3

Co-chairman and Coordinating Author of the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide - “Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems”.

Contributing author to the International Society for Pharmaceutical Engineering’s (ISPE) Good Practice Guide on Ozone. Technical Editor of the Journal of the Institute of Environmental and Science Technology (IEST), Technical Reviewer of Pharmaceutical Engineering, Chairman of the Water and Steam Forum of ISPE, Founder/Chair of the Discussion Forums of ISPE, Former member of the Technical Advisory Board of A2C2 magazine.

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