Purified water systems are among the most heavily scrutinized utilities in GMP facilities. Validation is not a final step — it begins during design, when loop sizing, dead legs, and sanitization strategy are defined.
A robust commissioning plan covers mechanical completion, pressure testing, flushing, and performance qualification. Each phase should produce traceable records: isometric drawings, weld logs, instrument calibration certificates, and trend data from trial runs.
Common pitfalls include undersized storage capacity, inadequate loop velocity, and missing sample points for microbiological monitoring. Addressing these during engineering prevents costly modifications after go-live.
Midex supports clients through design review, FAT witness, site installation, and SAT documentation — ensuring PW stations meet both operational and regulatory expectations.