HJ Puritech Stainless Steel Pass-Through Chamber (304 SS, Standard Type)

Overview

The HJ Puritech Stainless Steel Pass-Through Chamber (304 SS, Standard Type) is an engineered solution for controlled material transfer between adjacent cleanroom zones—such as ISO Class 5 to ISO Class 8 environments—or between classified and non-classified areas. It operates on the fundamental principle of physical isolation: by eliminating direct door-opening events between zones, it mitigates airborne particulate ingress, microbial load transmission, and pressure cascade disruption. Constructed entirely from AISI 304 stainless steel—including walls, shelves, and internal surfaces—the unit resists corrosion, supports repeated disinfection with alcohol, hydrogen peroxide vapor (HPV), or sporicidal agents, and complies with surface finish requirements for GMP-compliant pharmaceutical and biotech facilities (per EU Annex 1 draft guidance §5.22). Unlike laminar-flow or self-cleaning variants, this standard pass-through relies on passive containment, dual-door interlocking, and integrated UV-C irradiation to maintain bioburden control during item exchange.

Key Features

• Full 304 stainless steel construction (body, door frames, interior panels, and work surface) ensures long-term structural integrity and compatibility with stringent cleaning validation protocols.
• Mechanical or electronic interlock system enforces strict sequential operation: one door must be fully closed and latched before the opposing door can be unlocked—preventing simultaneous open states that compromise pressure differentials.
• Integrated 254 nm UV-C lamp (low-pressure mercury vapor type) delivers ≥ 40 µW/cm² irradiance at 1 m distance, validated for ≥ 99.9% reduction of common surface microbes (e.g., Bacillus subtilis spores, Staphylococcus aureus) after 15–30 min exposure—per ISO 15714:2019 test methodology.
• Electro-polished internal surfaces (Ra ≤ 0.8 µm) minimize particle adhesion and facilitate visual inspection and residue-free wipe testing.
• Optional DOP (Di-Octyl Phthalate) test port enables in-situ filter integrity verification using photometer-based challenge testing—critical for FDA 21 CFR Part 11–aligned qualification documentation.
• Configurable with analog or digital differential pressure gauge to monitor static pressure delta across the chamber, supporting continuous compliance with ISO 14644-3 monitoring requirements.

Sample Compatibility & Compliance

This pass-through chamber accommodates rigid, non-powdered, non-volatile items up to 1000 mm (W) × 1080 mm (H) × 1060 mm (D) internal dimensions (model-dependent). Compatible with sterile trays, glassware, tooling fixtures, component carriers, and sealed secondary packaging. Not intended for aerosol-generating materials, open liquid containers, or heat-sensitive devices requiring active temperature control. Meets structural and material specifications referenced in ISO 14644-1, ISO 14644-3, and EU GMP Annex 1 (2022) for auxiliary cleanroom equipment. All electrical components—including interlock solenoids and UV ballasts—carry CE marking and conform to IEC 61000-6-3 EMC standards.

Software & Data Management

As a Class I passive device per IEC 62304, this unit requires no embedded firmware or data logging capability. However, optional electronic interlock modules support dry-contact outputs compatible with building management systems (BMS) or SCADA networks for event logging (door open/close timestamps, UV activation cycles). When integrated into a validated environment, audit trails for UV usage duration and interlock status changes may be captured externally via PLC or MES—supporting ALCOA+ data integrity principles under FDA 21 CFR Part 11 and EU Annex 11.

Applications

• Pharmaceutical manufacturing: Transfer of pre-sterilized components between Grade C and Grade A filling suites.
• Medical device assembly: Controlled handoff of machined housings between ISO Class 7 assembly and ISO Class 5 packaging areas.
• Cell therapy labs: Exchange of cryovial racks between cold rooms and biosafety cabinets without breaching containment.
• Microelectronics fabrication: Movement of wafer carriers across classification boundaries while preserving nanoscale particulate control.
• Vaccine development facilities: Isolation of analytical reference standards during QC sample distribution.

FAQ

Is this unit certified to ISO 14644-1 Class 5?
No—this is a pass-through chamber, not a cleanroom. It supports Class 5 environments but does not generate or certify air cleanliness. Its design aligns with ISO 14644-1 Annex B.3 for ancillary equipment.
Can the UV lamp be replaced in situ without tools?
Yes—lamp access is via front-panel quick-release cover; replacement requires only standard Philips-head screwdriver and UV safety goggles.
Does the mechanical interlock meet GMP traceability requirements?
Mechanical interlocks provide physical assurance but lack electronic event logs. For full traceability, specify the electronic interlock option with BMS integration.
What is the maximum allowable load per shelf?
Uniformly distributed static load capacity: 50 kg per shelf, verified per EN 1090-2 structural assessment.
Is weld certification available for the 304 SS seams?
Yes—weld procedure specification (WPS) and procedure qualification record (PQR) documentation is provided upon request for ASME BPVC Section IX compliance.