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Cleanroom Transfer

Finish: Electropolished (Ra < 0.4 µm)100% Traceable SS

Himalayan Steel Precision Series

SS Dynamic Pass Box (HEPA Filtered)

Himalayan Steel Industries manufactures active dynamic pass boxes engineered to transfer materials between classified and unclassified cleanroom areas without cross-contamination. Features vertical laminar airflow with certified EU-14 / H14 HEPA filters, internal R15 coved sanitary corners, and automated electromagnetic door interlocks.

Available Metallurgies

SS 316L InternalSS 304 External

Regulatory Compliance

ISO 14644-1 Class 5 CompliantcGMP Approved DesignUS FDA 21 CFRCE Certified

✓ Direct factory prices•✓ Material Test Certificate (MTC 3.1) included•✓ Pan-India Delivery

Engineering Overview & Fluid Dynamics

Active contamination barrier and laminar downflow principles

The Himalayan Steel Industries Dynamic Pass Box is an active cleanroom material airlock engineered for contamination-free transfer between areas of differing cleanliness classifications (e.g., ISO Class 7 / Grade C to ISO Class 5 / Grade A). Equipped with a closed-loop recirculation blower, pre-filtration, and certified H14 HEPA filtration, it establishes a sterile vertical laminar downflow over articles inside the chamber. Microprocessor-controlled electromagnetic door interlocking guarantees that outer and inner doors can never be opened simultaneously, safeguarding cleanroom differential pressure cascades and preventing particulate or airborne microbial ingress during transfers.

Technical Engineering Specifications

Standard dimensional tolerances, electrical parameters, and air quality ratings

Cleanliness ClassISO Class 5 / Class 100 downflow

Supply FiltrationAluminum framed HEPA H14 (99.997% @ 0.3 micron)

Suction Pre-FilterStainless steel EU-4 washable mesh (95% @ 5 micron)

Air Velocity0.45 ± 0.1 m/s (90 ± 20 FPM)

Blower AssemblyHigh static dynamically balanced centrifugal motor blower (<65 dB)

Interlocking System12V DC electromagnetic microprocessor interlock with optical sensors

Pressure MonitoringDwyer Magnehelic® 0–25 mm WC differential gauge

Power Supply220V - 240V AC / 50 Hz Single Phase

UV SterilizationGermicidal UV-C tube (254 nm) with digital hour run counter

Door View PanelsDouble-glazed flush tempered glass view panels

Standard Dimensional Matrix

Fabrication schedule comparison in Imperial and Metric standards

Custom dimensions available on request

Size (Feet)	Metric (MM)	Internal Chamber (W x D x H)	External Footprint (W x D x H)
1 x 1 x 1 ft	305 x 305 x 305 mm	305 x 305 x 305 mm	450 x 420 x 760 mm
1.5 x 1.5 x 1.5 ft	457 x 457 x 457 mm	457 x 457 x 457 mm	610 x 570 x 915 mm
2 x 2 x 2 ft (Standard)	610 x 610 x 610 mm	610 x 610 x 610 mm	760 x 720 x 1100 mm
2 x 2 x 3 ft	610 x 610 x 915 mm	610 x 610 x 915 mm	760 x 720 x 1400 mm
2.5 x 2.5 x 2.5 ft	762 x 762 x 762 mm	762 x 762 x 762 mm	915 x 870 x 1250 mm
2.5 x 2.5 x 3 ft	762 x 762 x 1067 mm	762 x 762 x 1067 mm	915 x 870 x 1550 mm
3 x 3 x 3 ft (Bulk Container)	915 x 915 x 915 mm	915 x 915 x 915 mm	1070 x 1020 x 1400 mm
3 x 3 x 4 ft	915 x 915 x 1220 mm	915 x 915 x 1220 mm	1070 x 1020 x 1700 mm
4 x 4 x 4 ft (Pallet & Drum)	1220 x 1220 x 1220 mm	1220 x 1220 x 1220 mm	1370 x 1320 x 1700 mm

Note:External dimensions include top motor plenum and side return ducting. Himalayan Steel Industries custom-tailors flange profiles to fit any wall panel thickness (50 mm, 80 mm, 100 mm).

Cleanroom Construction & Architectural Design

cGMP sanitary fabrication details from our Baddi engineering works

Seamless Coved Chamber (R15 Radius)

Internal chamber is formed with continuous GTAW / TIG welds and mechanical R15 corner coving. Every weld is ground and electropolished to Ra < 0.4 µm, completely preventing particulate traps and microbial harboring.

Double-Skin Flush Door Profiles

Double-wall sandwich insulated doors fitted with seamless food-grade silicone gaskets and flush-mounted toughened safety glass windows that seal airtight against positive cleanroom differential pressures.

Microprocessor Electromagnetic Interlocking

Advanced 12V DC fail-safe magnetic locks integrated with optical door position sensors and LED indicators. When one door unlatches, the opposite door is locked instantaneously to safeguard cleanroom airflow integrity.

DOP / PAO Aerosol Challenge Port

Dedicated upstream challenge sample port allows convenient on-site aerosol dispersion and downstream photometer scan validation for mandatory annual HEPA filter integrity and leak testing.

Low-Vibration Motor Blower Assembly

Heavy-duty direct-drive centrifugal fan statically and dynamically balanced to ISO 1940 standards, providing smooth 0.45 m/s laminar air velocity while keeping operational acoustic levels under 65 dB(A).

Perforated Stainless Air Return Plenums

Bottom and side perforated stainless grilles extract downward air seamlessly into recirculating side plenums across the washable stainless EU-4 pre-filter stages.

Standard Operating Protocol (cGMP SOP)

Standard operating guidelines and contamination control sequence

SOP REFERENCE GUIDE

Objective

To define a standardized cGMP procedure for transferring materials across cleanroom barriers using the Himalayan Steel Dynamic Pass Box without contaminating classified airlocks.

Scope

Applies to all material transfers across formulation suites, vial filling cleanrooms, packaging airlocks, and sampling rooms.

Responsibility

Cleanroom Production Operators, HVAC Technicians, and QA Validation Officers.

Step-by-Step Material Transfer Sequence

Check power supply and verify that the Dwyer Magnehelic® gauge indicates normal operational pressure differential (8 mm to 15 mm WC / 80 to 150 Pa across the HEPA filter).

Verify that both doors are closed and the green 'READY' status indicator illuminates on the operator control panel.

Open the loading-side door (from the lower-grade or corridor side). The electromagnetic interlock instantly locks the opposite cleanroom door.

Place pre-sanitized containers or materials on the perforated stainless steel platform, ensuring articles do not block side air return grilles.

Close the loading door completely. The automatic air purge cycle and germicidal UV-C cycle activate for the pre-set duration (typically 3 to 5 minutes of Class 100 laminar wash).

Once the purge timer completes, the green 'UNLOCKED' indicator on the cleanroom side illuminates. The operator in the classified room may now open the door and retrieve the articles.

Close the cleanroom door firmly. The pass box automatically resets to standby ready status.

Sanitization & Wipe-Down Protocol

Perform pre-shift sanitization using lint-free microfiber wipes soaked in filtered 70% Isopropyl Alcohol (IPA) or 20% approved hydrogen peroxide solution.
Wipe the chamber surfaces systematically starting from top (HEPA protective grille) downwards to side walls, door interiors, and bottom perforated floor.
Inspect suction pre-filter mesh weekly; rinse with purified water, allow to air dry under laminar flow, and refit securely.
Record UV-C lamp operational run hours at the beginning of each production batch.

Fail-Safe Interlock Protection

Simultaneous door opening is electronically blocked in all standard operating modes.
Emergency mushroom push-buttons installed on both sides allow immediate interlock release in safety or power-loss conditions.
Buzzer alarm sounds if any door remains open beyond 60 seconds to prevent pressure cascade drops.

Optional Engineering Customizations

Site-specific hardware adaptations

Dwyer Magnehelic® or Minihelic® 0–25 mm WC differential pressure gauge
Differential pressure transmitter (4–20 mA output) for Building Management System (BMS) logging
Digital UV-C hour run counter with automatic replacement warning
Static neutralizing anti-static ionizer bar for plastic / glass container transfer
FLAMEPROOF / ATEX Certified motor blower for hazardous solvent zones
Grade 316L Stainless Steel floor support stand with leveling vibration pads
Audio-visual door ajar alert buzzer with configurable timeout (30s to 120s)
Touchless infrared proximity sensors for hands-free door unlatching

Quality Validation Package (DQ/IQ/OQ)

Audit-ready documentation for US FDA and EU-GMP inspections

Design Qualification (DQ) Documentation & GA Engineering CAD Drawings
Installation Qualification (IQ) Protocol & Test Checklists
Operational Qualification (OQ) Protocol & Site Acceptance Testing (SAT)
Material Test Certificate (EN 10204 Type 3.1) with Spectrometer Chemical Analysis
Factory Acceptance Test (FAT) Report including DOP/PAO HEPA Filter Integrity Scan
Air Velocity Profile and Particle Count Certificate (ISO 14644-1 Class 5)

Cleanroom Design Highlights

Seamless all-welded SS 316L inner chamber with coved R15 radiused corners for sterile wipe-downs
Electronic door interlocking prevents simultaneous opening and avoids differential pressure loss
DOP / PAO aerosol testing challenge port for on-site HEPA validation and integrity audits
Audio-visual alarm system triggered if any door is left open beyond set cycle time

Target Pharmaceutical Applications

Aseptic Sterile Filling Suites (Grade A/B)

Vial Washing & Sealing Cleanroom Airlocks

Intermediate Raw Material (IRM) to Sampling Rooms

Biotechnology & Vaccine Formulation Suites

Chemical & Microbiology Quality Control Labs

Sterile Ointment & Injectable Manufacturing

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