Pharmaceutical Water Systems must be appropriately maintained in order to produce high quality water. USP General Chapter <1231> Water for Pharmaceutical Purposes provides detailed information about nearly every aspect of maintaining, qualifying, and monitoring a pharmaceutical water system. Microbial control is unarguably the most challenging aspect of operating a pharmaceutical water system, which is why it is discussed extensively in <1231> along with how to monitor it. This webinar specifically addresses microbial monitoring issues, including biofilm development, microbial test methods, water sampling purposes and procedures, the “trigger levels” associated with the test results, and microbial identification. Other elements of the USP Chapter <1231> will be discussed in future webinars.

Subject area:
Drug Products & APIs

Objectives (If applicable):
• Understand the basics of water system biofilm growth
• Understand the available test method options for determining the microbiome in your system
• Learn the process control and quality control uses of the micro data, including Alert and Action Levels and Specifications
• Understand the importance of proper and consistent sampling technique and locations
• Learn when and why microbial identification is needed

Target Audience (If applicable):
– Analytical microbiologists
– Microbiology lab managers
– QA/QC managers
– Water system engineers, owners, and users
– Production managers
– Compliance managers
– Regulatory affairs specialists