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. The course examines the systems that produce these waters as well as the chemical and microbiological controls that are required to ensure chemical and microbiological attributes are maintained. The course will also address proposed changes for the water related USP General Chapters Total Organic Carbon <643> , Water Conductivity <645> and Water for Pharmaceutical Purposes <1231>.
The live version of this recording took place on April 21 - 22, 2021.
Upon completion of this course, you will be able to:
- Explain the importance of source water quality and pre-treatment concerns.
- Summarize the requirements for purified water, water for injection and other USP water monographs, including specifications, testing, and instrumentation.
- Explain the impact of elemental impurities requirements according to USP General Chapter <232>.
- Describe how biofilm propagates in pharmaceutical water systems.
- Explain 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.
- Summarize the pending and ongoing pharmaceutical water initiatives
Who should participate:
- QA & QC Scientists
- QA & QC Managers/Staff
- Maintenance Personnel
- Regulatory Authorities
- Pharmaceutical Engineers
- Process Engineers
- Water Systems Designers
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
The accompanying USP General Chapter(s) available as resources with this course, were official as of the date indicated in the chapter PDF. Please check www.uspnf.com for relevant updates.
USP Approved Instructor
Anthony Bevilacqua, Ph.D.
USP Consultant, Chemical Analysis Expert Committee
Ph.D., Analytical and Physical Chemistry
M.S., Chem