Pharmacy Courses

Water for Injection (WFI) System Validation Process

In this article we discuss about how to preform WFI system validation in pharmaceuticals and its acceptance criteria.

1. Perform Installation Qualification. Verify piping, fittings, proper dimensions drawings, wiring, PC software, calibration, and quality of materials.

2.  Check flow rates, low volume of water supply, excessive pressure drop, resistivity drops below-set point, and temperature drop or increase beyond the set level.

3.  Perform general operational controls verification testing.

4.  Operate system throughout the range of operating design specifications or range of intended use.

5.  System regulators must operate within ±2 psi of design level.

6.  Operate the system as per SOP for operation and maintenance of purified water system.

  • Perform sampling over a 1 month period per the sampling procedure and schedule.
  • Test samples for conformance to current USP Water for Injection monograph, microbial content and endotoxin content.
  • Identify all morphological distinct colony forming units (CFUs) to at least the genus level.

7.  Measure the flow rate

8.  Record the range of all process or equipment parameters (set points, flow rates, timing sequences, concentrations, etc.) verified during Operational and Performance Qualification testing.

The following shall be verified:

1.  The system is installed in accordance with design specifications,  manufacturer recommendations, and cGMPs. Instruments are calibrated, identified, and entered into the calibration program.

2.  General controls and alarms operate in accordance with the design


3.  The system operates in accordance with design specifications throughout the operating range or range of intended use.

4.  The system flow rate must be in compliance with design specifications.

5.  All samples must meet the following criteria:

a.  Chemical Testing: Test samples must meet the acceptance criteria of the chemical tests as described in USP Monograph on Water for Injection.

b.  Bacteriological Purity: All samples must contain no more than 10 cfu/100 ml; no pseudomonas or coliform is detected.

c.  Endotoxins: All samples must contain no more than 0.25 EU/ml.

d.  Physical Properties: The temperature of the hot Water for Injection must be greater than 80°C.

e. Particulate Matter: Small Volume Injection: The Small Volume Injection meets the requirements of the test if the average number of particles.

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Resource Person: Hassan Hussein

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