Water quality specifications for a water system validation

A pure water system is one of the most sensitive units in a manufacturing plant. This holds especially true for pure water systems in pharmaceutical drugs and medical device manufacturing industries. Hence, an efficiently designed pure water system will pass all the required water system validation required by the agencies. Below are some major water quality specifications that a pure water system needs to adhere to –

1. Total Organic Carbon (TOC) level – TOC is the total amount of organic content in the pure water system. This is the ultimate microbial test in the water system validation in the pharmaceutical manufacturing industry. A high purity water system will have a TOC monitor on site to facilitate accurate and fast measurement of TOC levels in the water.
2. Conductivity or Resistivity – Purified water has very low levels of conductivity, especially if it is produced in systems utilizing deionization methods. In addition to a conductivity meter, water system validation guidelines stipulate the installation of a resistivity meter to accurately effect the measurement of water purity levels.
3. Microbial testing – Microbial testing is performed on a system to check for presence of bacteria and endotoxins. Growth of bacteria and other endotoxins is impeded greatly by the design of a water purification system. An efficient water system validation process ensures that the water purification unit passes all the required microbial testing.