HJ Stainless Steel Cleanroom Air Shower Pass-Through Chamber

Overview

The HJ Stainless Steel Cleanroom Air Shower Pass-Through Chamber is an engineered solution for controlled material transfer between classified cleanroom zones—such as ISO Class 5 (Class 100) to ISO Class 7 (Class 10,000) environments—or between clean and non-clean areas. Unlike standard pass-through chambers, this unit integrates a high-velocity air shower system with integrated HEPA filtration, actively decontaminating surfaces of transferred items before entry into the higher-grade clean zone. It operates on the principle of laminar airflow impingement: conditioned air is forced through precisely aligned nozzles at ≥20 m/s, dislodging and removing particulate contaminants (≥0.3 µm) from object surfaces via kinetic energy and turbulent shear. Designed in strict compliance with ISO 14644-1 cleanroom performance standards and aligned with GMP Annex 1 (2022) requirements for material transfer integrity, the chamber minimizes door-opening frequency, mitigates cross-contamination risk, and supports validated facility operations.

Key Features

• Full-body construction from electropolished AISI 304 stainless steel (1.2 mm thickness), ensuring corrosion resistance, non-shedding surface integrity, and compatibility with IPA/water-based disinfectants.
• Dual interlocked doors with fail-safe mechanical or programmable electronic locking—preventing simultaneous opening per ISO 14644-3 Annex B. Door status is monitored and logged for audit trails.
• Integrated centrifugal blower and H14-class HEPA filter (EN 1822-1:2019 certified), delivering ≥99.995% particle capture efficiency at MPPS (Most Penetrating Particle Size) of 0.3 µm.
• Adjustable air shower cycle (typically 10–30 s, field-configurable), triggered automatically upon door closure; optional delay timer extends dwell time for oversized or irregularly shaped items.
• UV-C germicidal lamp (254 nm, low-ozone quartz sleeve) mounted internally for surface sterilization during idle periods—operates independently of air shower function.
• EVA compression gasket system across all perimeter joints ensures leak-tight sealing (<0.01% leakage at 500 Pa differential pressure), verified per IEST-RP-CC002.3.

Sample Compatibility & Compliance

The chamber accommodates rigid, non-porous small-to-medium payloads—including stainless steel trays, glass vials, tooling fixtures, wafers (up to 300 mm), and sealed component carriers—without compromising airflow uniformity. It is not intended for porous, fibrous, or heat-sensitive materials requiring low-velocity handling. All electrical components comply with IEC 61000-6-3 (EMC) and IEC 60601-1 (safety). Optional DOP test ports enable quantitative filter integrity verification per ISO 14644-3 and FDA guidance. The unit supports integration into facilities operating under EU GMP Annex 1, USP /, and ISO 13485 quality systems. Documentation includes Factory Acceptance Test (FAT) report, filter certification, and material traceability records.

Software & Data Management

While the base configuration uses hardwired logic control, optional digital controllers support RS-485 Modbus RTU output for integration into SCADA or MES platforms. Cycle logs—including timestamp, door open/close events, UV activation, and air shower duration—are stored locally (10,000-event buffer) and exportable via USB. Audit trail functionality complies with FDA 21 CFR Part 11 requirements when paired with validated access-controlled firmware (optional upgrade). No cloud connectivity is embedded; data sovereignty remains fully on-site.

Applications

• Pharmaceutical aseptic manufacturing: transfer of stoppers, syringes, and isolator gloves between Grade C and Grade A zones.
• Semiconductor front-end fabs: introduction of FOUPs and reticle carriers into lithography cleanrooms while maintaining particle counts <10 particles/ft³ (≥0.1 µm).
• Medical device assembly: controlled passage of sterilized instruments into ISO Class 5 packaging rooms.
• Research laboratories: barrier transfer of calibrated sensors, optical components, and microfluidic chips without breaking environmental classification.
• Vaccine production facilities: compliant handover of single-use bioreactor bags between classified preparation and filling suites.

FAQ

What cleanroom classifications is this pass-through chamber rated for?
It is designed to maintain separation between adjacent zones differing by up to two ISO classes (e.g., ISO 5 ↔ ISO 7) and is typically installed at the boundary of critical process areas per ISO 14644-4 design guidelines.
Can the HEPA filter be replaced onsite without tools?
Yes—the filter housing features quick-release clamps and gasket alignment guides; replacement requires only a torque-limited screwdriver and takes <15 minutes with trained personnel.
Is validation support documentation provided?
HJ supplies IQ/OQ protocol templates, filter test reports (DOP/PAO scan data), airflow visualization records (smoke study), and calibration certificates for UV intensity and air velocity sensors.
Does the unit meet fire safety requirements for cleanroom wall penetration?
All internal insulation meets UL 94 V-0 flame rating; structural framing complies with NFPA 90A for air handling penetrations, and optional fire-dampening collars are available for rated wall installations.
Can it be integrated with building management systems (BMS)?
Standard analog 4–20 mA outputs (door status, fault alarm, cycle complete) and Modbus RTU interface enable direct BMS linkage without third-party gateways.