cert: 3907.1
Water Purification Systems
Purified water system is essential for industrial, pharmaceutical and hospital purposes, in the preparation and processing of medicines and other health products and for cleaning
and hygiene purposes. Water in general it can contain up to 90 possible unacceptable contaminants.
Ensuring your water treatment system is performing to specification is very important.
I2S will perform four water quality specifications in validating your purified water systems
1. We Check Total Organic Carbon (TOC) Level
The TOC level indicates the total amount of organic content in a purified water stream. This number is the ultimate microbial test in a validated purified water system.
The maximum TOC level for most purified water systems is 500 parts per billion.
We perform on-site TOC measurement to your lab purifier with a TOC monitor.
2. Water Quality Measured in Conductivity or Resistivity
Highly purified water systems has a very low conductivity level, which results in the need for a resistivity meter. Our service technicians will measure the conductivity resistivity of your system using meters that can accurately measure a very low level of conductivity. FDA generally recognizes a resistivity measurement as an acceptable alternative to the conductivity standard.
When measuring water’s resistivity, water quality standards vary greatly with the high being 18.3 Megohms. At this level of resistivity, the pH of the purified water is 7.
3. Microbial Testing (Bacteria and/or Endotoxins)
Bacteria is measured in CFUs (Colony Forming Units) per milliliter (ml). A TPC (Total Plate Count) test is a waterborne bacteria test that indicates how much bacteria is in a water sample.
For the validation process, bacteria is normally measured at levels somewhere less than 100 CFU/ml. Endotoxins are gram negative bacteria particles and are measured in EUs (Endotoxin Units) per milliliter (ml).
We can limit the amount of microbial growth in water by the way we design a water purification system. Each system should include bacteria control equipment, such as UV technology and a high quality “final” filter, the last filter in line before the water leaves the production area.
4. Water Flow Rate
Additional step in your water system validation is checking the flow at a high enough velocity (greater than 3 feet per second) to inhibit microbial growth in the system.
