This webinar on pharmaceutical water systems will explain practical best practices for outlet use and sampling to reflect the true water quality and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination.
This presentation will correct these misunderstandings and explain practical best practices for outlet use and sampling to reflect the true water quality, including grab samples and on-line testing, that could pave the way to adoption of dramatic resource saving Real-Time Release approaches for BOTH chemistry and microbiological attributes of these waters.
Why Should You Attend:
Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly inconclusive problem investigations. At the heart of the problem is a fundamental misunderstanding of the purposes and practice of sampling and testing, and how to most effectively use the resulting data to improve manufacturing’s water use practices and maintain water system control before problems arise from biofilm-related contamination.This presentation will correct these misunderstandings and explain practical best practices for outlet use and sampling to reflect the true water quality, including grab samples and on-line testing, that could pave the way to adoption of dramatic resource saving Real-Time Release approaches for BOTH chemistry and microbiological attributes of these waters.
Learning Objectives:
- Dispel mistaken paradigms regarding the purpose of sampling.
- Understand how to eliminate sampling variability - the cause of most deviations.
- Understand how to best deliver water from a high purity water distribution system.
- Capitalize on the advantages of on-line analytical instrumentation.
- Understand the value and limitations of rapid microbiological methods as replacements for slow cultural approaches.
- Understand what it would take to transition to Real-Time Release of water.
Areas Covered in the Seminar:
- Importance of proper sampling.
- Process or Raw Material?
- Uses of water sampling data - PC or QC?
- Data use impact on sampling locations for.
- Chemical testing
- Endotoxin testing
- Microbial testing
- Data use impact on microbial sampling techniques.
- Sampling plan options.
- Test method options.
- Practicality of real time release.
Who Will Benefit:
This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to water:- Quality Assurance/Quality Control (Chem and Micro)
- Process and Design Engineering
- Process Automation
- Manufacturing Operations
- Validation
- Utility Operations
- Regulatory Affairs
Course Provider
T.C Soli,
