Quality, Standards & Compliance Framework
VENTAQ cleanroom environments and air management infrastructure are designed, manufactured, and commissioned in accordance with international pharmaceutical, laboratory safety, and environmental cleanliness standards.
ISO 14644-1
Cleanroom Airborne Particulate Cleanliness Classification
Specifies the classification of air cleanliness in terms of concentration of airborne particles per cubic meter of air, covering Class 4, Class 5, Class 6, Class 7, and Class 8 cleanrooms.
All VENTAQ partition envelopes and AHU suites are tested in-situ with calibrated optical particle counters to guarantee compliance at commissioning.
Key Regulatory Parameters & Thresholds
| ISO Class 5 (Grade A/B) | Max 3,520 particles/m³ at ≥ 0.5 µm (At Rest) |
| ISO Class 7 (Grade C) | Max 352,000 particles/m³ at ≥ 0.5 µm (At Rest) |
| ISO Class 8 (Grade D) | Max 3,520,000 particles/m³ at ≥ 0.5 µm (At Rest) |
| Recovery Time | < 15 to 20 minutes clean-up rate |
cGMP & Schedule M
Current Good Manufacturing Practice for Pharma Suites
Governs the physical layout, contamination containment, air handling, and surface finishes of pharmaceutical manufacturing suites under Indian (CDSCO Schedule M) and international regulatory audits.
Eliminates particle accumulation through flush double-glazed inspection windows, recessed lighting, and seamless monolithic floor-to-wall interfaces.
Key Regulatory Parameters & Thresholds
| Surface Finish | Flush, non-shedding, crack-free, non-porous |
| Wall-Floor Transition | 50mm / 75mm continuous sanitary radius coving |
| Airlock Protocol | Dedicated Personnel (PAL) & Material (MAL) airlocks |
| Differential Pressure | Minimum 10 – 15 Pa cascade across doors |
EU GMP Annex 1 & USFDA
Sterile Medicinal Product Manufacturing Guidelines
Detailed standards for sterile processing suites, specifying unidirectional laminar airflow velocities (0.45 m/s ± 20%), continuous particle monitoring, and microbial environmental control.
AHU suites and cleanroom panels engineered with corrosion-resistant SS 304/316 surfaces capable of enduring daily automated VHP bio-decontamination.
Key Regulatory Parameters & Thresholds
| Unidirectional Velocity | 0.45 m/s (90 fpm) ± 20% at working height |
| Continuous Monitoring | BMS interface for differential pressure & airflow |
| Disinfection Resistance | Resistant to vaporized hydrogen peroxide (VHP) |
| HEPA Integrity | DOP / PAO aerosol leak test (< 0.01% penetration) |
EN 14175 & OSHA 1910.1450
Laboratory Fumehood Aerodynamic Containment Safety
International standard evaluating the containment capability, face velocity uniformity, and aerodynamic robustness of laboratory fume cupboards under simulated room air cross-drafts.
Equipped with aerodynamic airfoil sills and bypass grilles preventing vortex backflow and toxic chemical escape toward the researcher.
Key Regulatory Parameters & Thresholds
| Face Velocity | 0.40 – 0.60 m/s uniform aerodynamic draw |
| Containment Testing | SF6 tracer gas containment test (EN 14175-3) |
| Containment Robustness | Tested against moving walk-by aerodynamic drag |
| Sash Safety | Laminated tempered safety glass with auto-stop |
Turnkey Qualification Protocols (DQ / IQ / OQ / PQ)
Every facility commissioned by VENTAQ is accompanied by complete, audit-ready validation documentation.
Design Qualification
Documented verification that the proposed design of the cleanroom envelope, HVAC capacity, and airflow distribution complies with the client URS and regulatory mandates.
Installation Qualification
On-site physical inspection confirming that all panels, ductwork, terminal HEPA filters, blowers, and instrumentation are installed per approved engineering drawings.
Operational Qualification
Verification that the facility operates within specified parameters: airflow volume balancing, room pressure cascade testing, smoke pattern airflow visualization, and HEPA filter PAO leak testing.
Performance Qualification
Documented verification that the cleanroom consistently achieves specified airborne particulate classifications (ISO Class 4–8) under simulated operational conditions.
Preparing for a Regulatory or cGMP Audit?
Our engineering team assists with on-site particle counter validation, HEPA filter integrity testing, smoke visualization, and preparation of documentation packages.