Cleanroom And Operating Room Projects Now Ship With Complete DQ IQ OQ PQ Validation Documentation Package

A cleanroom that measures clean but cannot prove it is clean will fail an audit. Regulators and hospital accreditation bodies want traceability: which filter was installed, when it was leak tested, who calibrated the gauge, what the particle count was at handover. YANING now ships every cleanroom and operating room project with a documentation package built alongside the equipment, not assembled afterwards.

• DQ, IQ, OQ, PQ templates - pre-filled with your equipment serial numbers, filter batch codes and instrument IDs
• Material certificates - EN 10204 3.1 for SS316L contact parts, panel core composition, gasket material data sheets
• Filter test records - individual HEPA serial number, efficiency scan result, PAO challenge date
• Calibration certificates - differential pressure gauges, velocity sensors, particle counters used during commissioning
• Commissioning test report - ISO 14644-1 classification, ISO 14644-3 tests, room pressure map, recovery time curves
• As-built drawings and O&M manual - including filter replacement schedule and alarm response flow chart

Pharmaceutical clients need cGMP alignment and EU GMP Annex 1 language in the qualification documents. Hospitals need accreditation-style evidence for theatre ventilation and infection control committees. The same template set is parameterised for both, so a distributor can hand a single folder to a pharma QA manager or a hospital engineering department and have it accepted without rework.

Serial numbers, filter batch codes and panel certifications are captured at the factory, when the parts are on the bench. Reconstructing that trail six months later from photographs and emails is where audits fail. Our production order cannot be released to packing until the documentation checklist is complete, which is a simple control that removes an entire category of audit findings.

Ask for a sample DQ IQ OQ PQ set and a commissioning report template with your quotation - we send the real documents, not marketing summaries.