Water System Compliance - Harmonizing Water Microbial Testing for Optimal Quality Control

As much compendial test method harmonization as has already occurred with Microbial Limits testing for non-sterile products and raw materials, surprisingly little has occurred with the microbial test methods used for testing water. Both USP and JP recommend methods in their non-mandatory informational chapters, and USP goes a step further to encourage the user to find the best method for their water systems which may not be a suggested method. EP is prescriptive about the method that should be used, but it is well-known that this method may not be optimal for many water systems because of the long delay in test results which could be identical from faster methods, leaving no room for emerging Rapid Micro Methods.

This presentation covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization those methods, the compendial allowances for utilizing alternative test methods, and a scientifically defensible approach to determining the optimal method for a given water system that is acceptable to all regulatory bodies.

Areas Covered in the seminar:

• Water harmonization that has already occurred.
• Water Micro Test Method “Dis-Harmonization”.
• Biofilm basics and how it develops.
• Biofilm diversity in water systems.
• Micro Test Method options and evaluation protocol.
• The good and bad of Micro Test Method harmonization.
• Where Rapid Micro Methods can fit in.

Who will benefit:

This webinar will be valuable for all companies manufacturing Medical Devices, Diagnostics, Pharmaceuticals, and Biologics whose laboratories utilize pharmacopoeial test methods for water system testing. The employees who will benefit include:

• Microbiology analysts who perform water testing.
• Microbiology laboratory supervisors and their managers.
• QA managers and personnel involved in establishing methods and specifications for water testing.
• Regulatory Affairs managers and personnel involved in defending laboratory operations to FDA and EMEA inspectors and outside auditors.
• Validation managers and specialists who must specify test functions and acceptance criteria for water system validation programs.
• Consultants.

Instructor Profile

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and has been consulting full time for 5 years, serving consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. Prior to consulting, he had 25 years of diverse "Big Pharma" operating company experience.

During his 30 year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for PDA and ISPE publications. He is currently Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>.

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