Sterile Raw Material Sampling Booth
Designed specifically for pharmaceutical Quality Control raw material sampling suites. Prevents environmental dust contamination of incoming chemical drums while protecting QC analysts during drum opening and sampling thief insertion.
Engineering Overview & Fluid Dynamics
Active contamination barrier and laminar downflow principles
The Himalayan Steel Sampling Booth is a specialized reverse laminar flow cleanroom unit engineered specifically for incoming material warehouse receiving suites. When raw material drums arrive from suppliers, sampling them presents twin hazards: cross-contaminating the bulk batch with warehouse airborne spores, and exposing the QC sampler to potent chemical dust. The sampling booth establishes an ISO Class 5 sterile downflow wash over the drum opening while maintaining a negative air barrier that captures airborne fugitive dust at bottom return grilles.
Technical Engineering Specifications
Standard dimensional tolerances, electrical parameters, and air quality ratings
Standard Dimensional Matrix
Fabrication schedule comparison in Imperial and Metric standards
| Size (Feet) | Metric (MM) | Internal Chamber (W x D x H) | External Footprint (W x D x H) |
|---|---|---|---|
| 4 x 3 ft (Single Drum) | 1200 x 1000 x 2200 mm | 1200 x 900 x 2000 mm | 1350 x 1350 x 2400 mm |
| 5 x 4 ft (Standard 2-Drum) | 1500 x 1200 x 2200 mm | 1500 x 1100 x 2000 mm | 1650 x 1550 x 2400 mm |
| 6 x 4 ft (Spacious QC Suite) | 1800 x 1200 x 2200 mm | 1800 x 1100 x 2000 mm | 1950 x 1550 x 2400 mm |
Cleanroom Construction & Architectural Design
cGMP sanitary fabrication details from our Baddi engineering works
Floor plate formed from reinforced 3 mm thick AISI 316L stainless steel capable of supporting 500 kg drums on pallet dollies without flexing.
All internal vertical and ceiling intersections are curved with 15 mm radius coving to prevent powder buildup and permit rapid mop-downs.
Multiple direct-drive centrifugal blowers ensure even downward laminar air velocity across the full width of the booth.
Equipped with factory-installed DOP challenge tubes for annual on-site HEPA validation without climbing overhead ductwork.
IP55 splashproof stainless steel electrical outlets provided inside for electronic sample scales and barcode scanners.
Stainless overhead tracking holds heavy-gauge antistatic PVC strips that overlap by 50 mm to block external air turbulence.
Standard Operating Protocol (cGMP SOP)
Standard operating guidelines and contamination control sequence
Step-by-Step Material Transfer Sequence
Sanitization & Wipe-Down Protocol
- Vacuum or wipe down gross powder using 70% IPA cleanroom wipes between different lots.
- Clean PVC curtains weekly with mild neutral disinfectant.
- Inspect and wash suction pre-filters monthly.
Fail-Safe Interlock Protection
- Air velocity sensor sounds alarm buzzer if downflow velocity drops below 0.35 m/s.
- Interlock ensures ceiling UV lights (if fitted) cannot operate while personnel are inside.
Optional Engineering Customizations
Site-specific hardware adaptations
- Stainless steel drum roller conveyor ramp for easy sliding of 200L drums
- Flameproof electrical fittings (Class 1 Div 1 / Zone 1) for flammable solvent handling
- Safe-change bag-in bag-out (BIBO) intermediate filter bank for potent compounds
- Adjustable stainless steel sampling tool holder and sanitization holster
- Integrated analytical printer and barcode label station shelf
Quality Validation Package (DQ/IQ/OQ)
Audit-ready documentation for US FDA and EU-GMP inspections
- Design Qualification (DQ) Documentation & Foundation Load Drawings
- Installation Qualification (IQ) Protocol Checklists
- Operational Qualification (OQ) Velocity & Airflow Mapping Protocols
- DOP/PAO Filter Leak Scanning Certificate
- Particle Count Validation Certificate (ISO 14644-1 Class 5 In-Operation)
- Factory Acceptance Test (FAT) Report
Cleanroom Design Highlights
- Accommodates full-size 200L fiber drums and HDPE chemical carboys with ease
- Eliminates sampling cross-contamination between different active raw material lots
- Anti-static clear PVC strip curtains isolate the sampling zone from warehouse drafts
- Continuous laminar wash prevents airborne particles from falling into opened containers
Target Pharmaceutical Applications
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