ISO 7 GMP Suite — Pressure Cascade

The challenge

A pharmaceutical client needed a grade C/D suite where the paperwork mattered as much as the build: QA required a documented pressure cascade, filter certificates, and test reports formatted for their validation master plan.

What we did

• Room-by-room cascade map with 15 Pa steps, differential gauges at every boundary, verified by smoke test
• Dynamic pass boxes with HEPA purge at all material transfers; personnel and material airlocks separated
• DX purification AHU with H13 terminals, 30-60 air changes in the ISO 7 core
• Handover pack: DQ drawings, airflow schema, filter certificates, third-party particle and microbial reports

Result

The validation pack was accepted by client QA without a revision cycle — the suite entered qualification on schedule.

CLIENT NAME WITHHELD UNDER NDA — DIRECT REFERENCE AVAILABLE TO QUALIFIED BUYERS ON REQUEST.