The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products
All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products 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, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. 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 lack of understanding of microbial control often leads to poor system designs, poor system sampling, poor system maintenance and poor sanitization practices, and as a result, ongoing microbial problems with the water.
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, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control and monitoring consists of a set of rules that often don’t work or result in erroneous monitoring data and can cause everything from very costly and unnecessary system downtime to patient injury and product recalls.
At the completion of the course, attendees will be able to:
Understand the role of system design, maintenance and sanitization in controlling microbial levels in pharmaceutical water systems.
Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems.
Devise water system validation protocols that truly validate microbial control.
Validate their water microbial test method.
Develop sound Alert and Action Levels and Water Specifications.
Defend their test method, in-process control levels and specifications to FDA.
Day One (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Basics of Water System Biofilm Control by Design & Operation
Understand biofilm basics and how it develops
Understand the impact of biofilm on the commonly used purification unit operations
Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development
Understand the how, where, and why of microbial monitoring, action levels, etc.
Debunk a few water system myths
Get answers to your own water system questions
Successful Water System Sanitization
Material and construction limitations
Continuous vs intermittent sanitization
The importance of biofilm removal
How sanitants work (or don’t work)
When to sanitize
Common causes for sanitization failures and troubleshooting sanitization problems
Common Sense Water System Validation
Why validate a water system?
Basic ground rules for water systems before you validate them
Minimum validation expectations
Making changes to a validated water system
Special considerations for lab water systems
Are packaged waters a viable option?
Understanding and Controlling Endotoxin
Where does endotoxin come from?
What are the properties of endotoxin ?
How do you get rid of it?
How do you detect it?
What assay controls are used?
What are the endotoxin specs for water?
How do you control it?
Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
Water harmonization that has occurred
Water Micro TM “Dis-Harmonization”
A little about Biofilm
Biofilm diversity in water systems
Micro TM options and evaluation protocol
The good and bad of Micro harmonization
Where RMMs can fit in
Day Two (8:30 AM – 4:30 PM)
Microbial Enumeration Issues with High Purity Water Systems
Biofilm enumeration issues (planktonic vs surface)
Traditional cultivative approach issues
Validation of your test method
Alternative TM choices (advantages/disadvantages)
Significance of water isolates
Establishing Alert/Action Levels and Water Specs and defending them to FDA
Reducing Water Microbial Excursions & Improving Investigations
What are excursions?
Water system dilemma: process control or quality control (utility or raw material), or both
Intended roles of Alert/Action Levels and Specifications
Investigation, necessary and often fruitless
Excursion responses and impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Water System Investigation "How-To´s" and Example Case Studies
Gathering and assessing existing data and symptoms
Considering user opinions
Investigation approach elements
Recognizing red herrings/false positives
Recognizing possible root causes
Water system contamination case studies
Leadership in Mfg Contamination Control: The Microbiology Lab
How contamination is controlled
Why the microbiology lab should lead in contamination control
Routine contamination evaluation activities
Root cause and impact investigations
Impediments to leadership
Doing the right thing
USP Chapter 1231 : What USP Says about PW, WFI, Pure Steam & Micro Issues
PW, WFI, Pure Steam micro specifications?
Starting water issues
Misunderstood issues clarified
Microbiological test issues clarified
Suggested micro test method
Alert and Action Levels and max’s
Recent/Upcoming USP water changes
Discrepancies between pharmacopeias
New water initiatives – need your input/feedback
Guarding Against Common Pharmaceutical Water System Inspection Pitfalls
Initial Deficiencies Usually Lead to Others
Design and Construction Issues
Source Water Issues
Change Control Issues
Excursion Investigation Issues