Purified water system validation and utility qualification
Generation and distribution loop qualification, three-phase PQ, sampling plans, and alert and action levels for purified water, plus sanitization program design and SIP and sterilization validation.
Qualifying a purified water system
A purified water system is a critical utility: it touches product, equipment, and cleaning. Qualification confirms that the generation skid and distribution loop are installed and operate as designed, then proves through performance qualification that the water consistently meets specification at every point of use.
PQ is typically run in three phases: an intensive daily sampling phase to establish operating ranges and procedures, a second daily phase to confirm consistency under those procedures, and a year-long phase to show the system holds up through seasonal variation in feed water.
Sampling, limits, and monitoring
We design sampling plans that cover every point of use, set alert and action levels from your own data, and define the trend review that keeps the system in control after qualification. Testing covers total organic carbon and conductivity per USP <643> and <645> alongside microbial monitoring.
Many systems arrive with a vendor IOQ. We review those packages before execution, so gaps are fixed on paper instead of becoming deviations in the field.
What we deliver
- Water system URS and design review
- Vendor IOQ review and gap protocols
- IQ/OQ of generation and distribution
- Three-phase PQ protocols and reports
- Sampling plans and point-of-use maps
- Alert and action levels and trending
- Sanitization program design
- SIP and sterilization validation
- Capital justifications for in-house testing
Regulations and standards
- USP <1231> Water for pharmaceutical purposes
- USP <643> Total organic carbon
- USP <645> Water conductivity
- 21 CFR Part 211
- ISO 22716
Common questions
How long does purified water system validation take?
Installation and operational qualification usually take weeks. Performance qualification takes longer by design: two intensive daily sampling phases of several weeks each, followed by a third phase that runs about a year to capture seasonal variation. Water can normally be released for use after the earlier phases succeed, under your quality unit's approval.
What is the difference between alert and action levels?
An alert level is an early warning that the system may be drifting from normal operation and calls for closer attention. An action level signals a departure that requires investigation and corrective action. Both should sit below the specification limit and be based on system data.
Should TOC testing be done in-house or outsourced?
It depends on sample volume. A PQ generates a large number of samples, and routine monitoring continues afterward. We build the cost comparison, including validation effort, so the decision is documented.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.