Engineered to WHO-GMP and PIC/S standards: Grade A laminar filling hood, Grade B background clean suite, liquid gel-seal HEPA diffusers, self-purifying dynamic pass boxes, and full DQ/IQ/OQ validation handover.
A regional pharmaceutical producer required a brand-new sterile liquid formulation and aseptic filling wing covering 1,650 m². The architectural and HVAC envelope had to satisfy stringent WHO-GMP guidelines with four environmental tiers: Grade D personnel gowning and washing airlocks, Grade C raw formulation preparation, Grade B cleanroom suite, and Grade A unidirectional laminar airflow over the open sterile ampoule filling conveyor.
Critical Compliance Gaps Addressed: The buyer required absolute zero bypass leakage on all ceiling terminal diffusers, seamless antimicrobial flush panel joints resistant to continuous vaporized hydrogen peroxide (VHP) decontamination, and calibrated on-site particle counter test logs to secure national Ministry of Health drug manufacturing licensing.
BESTCLEAN Integrated Engineering Package: BESTCLEAN provided complete cleanroom architectural envelope manufacturing (50mm aluminum honeycomb panels, flush coved SUS304 frames), proprietary knife-edge gel-seal HEPA terminal filter housings, laminar flow dynamic pass boxes with differential pressure gauges and DOP aerosol test ports, and dispatch of commissioning validation engineers with calibrated Met One laser particle counters.
Photographs from architectural BIM cutaway modeling, jobsite clean suite installation, and particle validation:
Pre-engineered 3D CAD modeling coordinating sandwich panel envelopes, supply air duct routes, return air riser walls, and cascade airlocks before fabrication.
Personnel operating between Grade C prep room and Grade B sterile corridor using BESTCLEAN dynamic pass box with 0.45 m/s downflow and Magnehelic pressure gauge.
Completed Grade B cleanroom equipped with non-shedding ceiling grid, seamless coved PVC wall joints, and flush double-pane tempered glass viewing panels.
Knife-edge ceiling outlet boxes utilizing polyurethane blue liquid gel sealant to eliminate gasket bypass leakage under high differential pressure.
Senior qualification engineer performing multi-point airborne particle counting and airflow uniformity profiling to verify Grade A/B compliance at rest and in operation.
Grade C/D personnel airlock scrub sink with hands-free infrared faucets, thermal temperature mixing valves, and seamless curved anti-splash basins.
| System / Category | Delivered Specification & Equipment Model | Quantity | Regulatory & Validation Protocol |
|---|---|---|---|
| Wall & Ceiling Panels | 50mm Aluminum Honeycomb Sandwich Panels (0.6mm PPGI skins, non-combustible) | 2,600 m² | VHP resistant, flush R50 coved aluminum transition profiles |
| Gel-Seal HEPA Units | BJ-GST Liquid seal terminal diffusers + H14 PTFE mini-pleat filters (99.995% @ 0.3µm) | 112 sets | DOP aerosol challenge injection port + upstream sampling port |
| Dynamic Pass Boxes | BJ-PB800-D SUS304 Dynamic Laminar Flow Pass Box with Magnehelic gauge & UV | 8 units | Class 100 internal cleanliness, electronic interlock, HEPA filtered |
| Airtight Pharma Doors | SUS304 Flush Cleanroom Doors with flush double-pane viewing windows | 36 sets | Concealed automatic acoustic drop sweeps, German dormakaba hardware |
| AHU Purification HVAC | Double-skin hygienic AHUs with inverter EC plug fans (22,000 m³/h capacity) | 4 systems | DIN 1946-4 hygienic design, steam humidifiers, chilled water cooling coils |
| Hygiene Scrub Stations | SUS304 3-station surgical sensor handwashing sink with integral backsplashes | 4 sets | Touchless infrared sensors, thermostatic mixing, medical scrub standard |
BESTCLEAN delivers comprehensive FAT/SAT and qualification protocols so pharmaceutical clients pass GMP inspections on the first attempt without regulatory delay:
Consult with our senior cleanroom engineers for HVAC cascade design, equipment selection, and full qualification support.