USP General Chapter <645> Water Conductivity is the primary method for determining inorganic/ionic impurities in Purified Water and Water for Injection (WFI), and has been adopted by multiple pharmacopoeias. USP <645> Water Conductivity is one of the two primary chemical limit tests (USP <643> Total Organic Carbon is the other) to determine that there is sufficient control/reduction of chemicals in the water purification system. In addition, electrical conductivity is also used as an analytical on-line, real-time process control tool for the entire water purification process and other manufacturing processes. This course will explain the purpose of this test, instrumentation and calibration requirements, on-line and off-line measurements, temperature compensation, and test limit requirements for various pharmaceutical waters.

Subject area:
Drug Products & APIs

Objectives (If applicable):
– Understand the basic principles of conductivity.
– Determine instrumentation and temperature compensation requirements.
– Understand the differences between on- and off-line measurements of pharmaceutical waters.
– Understand the test limits for the different stages of testing for various bulk and sterile waters for USP and other pharmacopoeia.
– Review <1644> Theory and Practice of Electrical Conductivity Measurements of Solutions.

Target Audience (If applicable):
– Analytical chemists
– QA/QC managers
– Compliance managers
– Water system engineers and owners
– Lab managers
– Production managers
– Regulatory affairs specialists