Water System Validations and Monitoring Tests

Water System Validations and Monitoring Tests

Water tests are used to evaluate the microbial content and chemical purity of water samples. Since water is an important environmental component, microbial control is a requirement of all Good Manufacturing Practices. Tests can be performed on spring water, process water, purified water, deionized water and highly purified water. Routine monitoring of the water system is also recommended to ensure continued compliance with the manufacturer's acceptance criteria and bioload monitoring programs.

Water System Validations and Monitoring Tests

EUROLABwill customize the water tests to meet the sponsor's exact needs. Our Technical Consulting team can also assist in writing IQ/OQ/PQ protocols for initial water system qualifications and associated validations, sampling plans, test frequency determination and fault investigations.

Applicable Standards

  • USP 1231
  • Standard Methods for Water and Wastewater Analysis
  • Good manufacturing practices

Sample Features

  • ENV210: 100 mL minimum
  • ENV215: 100 mL minimum
  • ENV220: 100 mL minimum
  • ENV230: 100 mL minimum
  • ENV240: 100 mL minimum
  • ENV250: 225 mL minimum
  • PWA320: 155 mL; please use appropriate sampling bottles.

Working Draft

In the water test, water samples for microbial testing are filtered using a 0.45 micron filter membrane to capture the microorganism. The membrane is then applied to an agar plate. After incubation, colony forming units are counted to yield organisms per milliliter.

Analysis is usually done by the test method described in Standard Water and Wastewater Examination Methods, which shows the use of membrane filtration and R2A agar. Depending on the type of water, coating can be applied on soybean casein digestion agar or selective agar for fungal growth. The amount of filtered sample, incubation time, and temperature parameters are variable and must be defined by the sponsor prior to testing. These variables are determined by the type of water sample.

For the analytical part of tests, conductivity, and TOC, water is scanned using equipment to determine conductivity and TOC. The use of TOC is important as it is an extremely sensitive, parts per billion (ppb) test method for coarse screening of organic material in water.

EUROLAB, with its highly expert team and internationally accredited laboratories, Water System Validations and Monitoring Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.

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