In-house Courses
Everything You Need to Know About Pharmaceutical Water System Microbiology
ABSTRACT
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance.
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement. The instructor can provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control consists of a set of rules that often don’t work and can cause very costly system downtime or even product recalls.
OUTLINE
In order to understand the microbiology of a water system, one has to understand biofilms since that is the mode of microbial growth in a water system. There is much hype and fear about water systems biofilms by users and regulators alike who do not understand how they grow, how to effectively control that growth, or even how to monitor their presence. This course will help you understand how microorganisms respond to our efforts (or lack of effort) to control their numbers and even to how we try to count them.
A key resource for this course is the latest revision of the USP informational chapter on water <1231> published in Supplement 2 to USP28. The course instructor is the primary author of that revised chapter.
Key Topics
- The “real” story behind some common water system design and control myths
- Biofilm properties and examples
- Biofilm resistances and susceptibilities
- Where they grow in water systems
- How routine water system maintenance impacts biofilm growth/removal
- Water system microbial enumeration issues
- USP’s view on sampling and microbial enumeration
- Microbial enumeration options/advantages/disadvantages
- How to “validate” a microbial enumeration method
- Significance of biofilm microbes
- Patient impact
- Product impact
- Water system impact
Who Should Attend
- New Microbiology Laboratory supervisors and Microbiologists responsible for water sampling and testing.
- Quality Assurance personnel responsible for water system deviation management
- Regulatory and Compliance professionals responsible for FDA interactions
- Process and Utility Engineers responsible for water system maintenance
- Facility Engineers responsible for water system design or renovation.
Learning Objectives
At the completion of this course, attendees will be able to:
- Understand the role of system design and maintenance in controlling microbial levels
- Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems
- Devise water system validation protocols that truly validate microbial control
- Validate your microbial test method
- Develop sound Alert and Action Levels and Water Specifications
- Defend your test method, in-process control levels and specifications to FDA
Please Note:
It is our intent to make our course a helpful to you as possible. It is offered through the Microbiology Network, and taught by recognized experts in the field. If you have a topic of special interest, or any questions of particular importance to you, please let us know in advance. This will allow the instructors an opportunity to incorporate your concerns into the course. We know how critical your time and money are, and will do everything possible to ensure ensure that you get value from this experience.
Note: This course is being offered in cooperation with the Microbiology Network
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