USP Purified Water (PW) is the most common pharmaceutical water grade — used for formulation, equipment washing, and as feedwater for WFI systems. Meeting USP <1231> and ICH Q7 requirements demands rigorous validation.
USP Purified Water Standards
| Parameter | USP Limit |
|---|---|
| Conductivity | ≤1.3 µS/cm at 25°C |
| TOC | ≤500 ppb |
| Microbial | ≤100 CFU/mL (action limit) |
| Endotoxins | Not specified for PW (WFI: <0.25 EU/mL) |
Required Validation Documents
- DQ (Design Qualification): System design vs. URS compliance
- IQ (Installation Qualification): Equipment installed per design
- OQ (Operational Qualification): System operates per design limits
- PQ (Performance Qualification): 3-phase, 12-month monitoring program
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