Course Description:
Much of USP–NF General Chapter <1231> Water for Pharmaceutical Purposes is devoted to instructing the water system owner/user of the issues associated with Microbial Control. Those issues are related to system design, choice of construction materials, routine operation, and routine unit operation maintenance, water delivery hose and connector care, and system sanitization, all intended to control or at least impede biofilm from getting a strong enough foothold in a water system to compromise its purification processes and/or contaminate the finished water used in the manufacture of pharmaceutical products. Attendees will learn about biofilm in water systems and how to successfully control it wherever it occurs, and why <1231> is a useful technical guide for microbial control in pharmaceutical water systems.
Upon completing this course you will be able to understand:
- How biofilm grows in high purity water systems
- Routine unit operation microbial control strategies
- Impact of construction material, component, and assembly choices
- Sanitization approaches that work (or don’t) and why
- Roles of process monitoring, ongoing microbial control, preventive maintenance, and change control in the success of microbial control
Who Should Participate:
- Analytical microbiologists and Micro lab managers
- QA/QC managers
- Water system engineers, owners, and users
- Production and utility managers
- Compliance and regulatory affairs managers
- Water system designers and installers