Water for Injection (WFI) System Validation Process

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 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.

Related: Removal of Pathogenic Bacteria from Water Systems

7.  Measure the flow rate and calculate the velocity of the water, or measure the velocity directly at a point between the last use point and the storage tank.

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.

Related: Reverse Osmosis System for Water Purification

Acceptance Criteria

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 specification.

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 it contains is not more than 10,000 per container that is equal to or greater than 10 µm in effective spherical diameter and not more than 1000 per container equal to or greater than 25 µm in effective spherical diameter.

Related: Water for Injection System Validation Protocol

Also see:

• Passivation of Purified Water System/ WFI System
• Types of Water used in Pharmaceutical Processes
• Biocontamination Control Techniques for Purified Water
• Purified Water System Validation
• WHO: Water for Pharmaceutical Use

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