Course Description
This two-day course explains compendial and regulatory requirements for source waters, Purified Water, Water for injection(s), Sterile Water for Injection and other sterile water monographs, Water for Hemodialysis and Pure Steam and examines the systems that produce these waters as well as the chemical and microbiological controls that are required for these systems. This course will also address proposed changes in the water related USP <643> Total Organic Carbon, <645> Water Conductivity Chapter and <1231> Water for Pharmaceutical Purposes.
Upon completion of this course, you will be able to:
- Explain the source water quality and pre-treatment concerns and why they are important.
- Define the requirements of Purified Water, WFI and other USP water monographs, including all specifications, testing, and instrumentation requirements.
- Explain the impact of Elemental Impurities requirements (outlined in the USP General Chapter <232>)
- Describe how biofilm propagates in pharmaceutical water systems
- Describe how biofilm impacts purification unit operations and water quality.
- Discuss how to control the chemical and microbial quality of the water.
- Identify the realities and myths for microbial control in pharmaceutical water systems.
- Discuss the pending and ongoing pharmaceutical water initiatives.
Who Should Participate:
- Water system designers
- Facility maintenance staff
- Facility/utility engineers
- Regulatory authorities
- Project managers
- Operations managers
- QA/QC staff
- Process engineers
- Pharmaceutical engineering students
Why Choose USP Education?
USP Education provides year-round courses and programs on how to effectively interpret and apply USP’s internationally recognized quality standards. The standards help ensure the quality and safety of medicines, dietary supplements and foods.
USP courses are created by the scientists and experts who help develop the USP standards that are used worldwide. Courses are presented by approved instructors with practical, first-hand knowledge of the subject area and related standards. The insights they share will not only make your daily work easier, but will also connect you to an independent, nonprofit scientific body with the goal of creating a strong foundation for a healthier world.