Most people who design, maintain, and monitor high purity water systems have heard of biofilm and a few "rules" about how to control and monitor it. Unfortunately, many of these "rules" such as flow rates, dead legs, surface smoothness and the like are taken out of original contexts and are either only half right or frankly wrong.

Once there is an understanding of the basics of how biofilm really develops on surfaces and how they are protected by the nature of that growth, it is easier to see how biofilm can impact the operability of various unit operations in a water system and why it is so hard to control and even to monitor accurately after it is established. The key to biofilm control is to always keep it from getting out-of-control.

This 3 hour session will review what biofilm is and how it grows, discuss specifically how it negatively affects just about every kind of unit operation used in today's water systems and how routine maintenance activities of those unit ops help to control it. It will also discuss how routine sanitization, with specific sanitizer examples, picks up where routine maintenance leaves off in controlling biofilm development, with discussions regarding mechanisms and relative efficacies of various sanitization approaches. But this webinar does not stop here.

Controlling biofilm development is a big part of having a successful water system, but there are many other compliance issues that also put water systems in regulatory cross-hairs during an inspection. So this webinar will also address the regulatory issues and pitfalls that are often the focus of a water system inspection with advice on how to prepare for them. This presentation is also intended to be interactive to the extent that your specific questions can also be addressed if they have't already been covered by the 3 presentations.

Course Objective

• Understanding how and where biofilm grows in a high purity water system and how that makes it so difficult to control.
• Understanding how biofilm growth affects the purification unit operations and their effluents
• Understanding how system design and routine maintenance can help keep biofilm at bay, but if improperly executed, can facilitate its proliferation.
• Understanding how routine sanitization and specific sanitizers work (or don't work) to provide either definitive biofilm control or recurring microbial problems, depending on sanitizer choice, how used and system design.
• Learning the common pitfalls and documentation deficiencies that lead to troubled water system inspections and how to avoid them.

Course Outline

Module 1-Essentials of Water System Biofilm Control by Design & Operation

• Biofilm basics and how it develops
• Biofilm impact on "active" surfaces
• Environmental resistances of biofilm
• Biofilm impact on purification unit operations and how to control it
• Good design practices to control biofilm
• Good maintenance practices to control biofilm

Module 2-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
• Initial Deficiencies Usually Lead to Others

Module 3-Guarding Against Common Pharmaceutical Water System Inspection Pitfalls

• Design and Construction Issues
• Source Water Issues
• Sampling Issues
• Validation Issues
• Change Control Issues
• Procedure Issues
• Specification Issues
• Excursion Investigation Issues
• Training Issues
• Process Understanding

Who Will Benefit:

This webinar will be valuable for all companies that operate high purity water systems, particularly for those in FDA and EMA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:

• Engineers involved in water system design
• Utility operators and their managers involved in maintaining water systems
• QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels
• QA managers and personnel involved in investigations of excursions and preparing CAPAs
• QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
• Validation managers and personnel
• Consultants and troubleshooters