Hujing Purification Stainless Steel DOP-Testable Pass-Through Chamber

Overview

The Hujing Purification Stainless Steel DOP-Testable Pass-Through Chamber is an engineered solution for controlled material transfer between classified cleanroom environments—specifically between ISO Class 5 (Class 100) or higher洁净 zones and adjacent lower-classified or non-classified areas. Designed in strict alignment with Good Manufacturing Practice (GMP) Annex 1 (2022), EU GMP Guide Part I, and ISO 14644-1/ISO 14644-3 requirements, this pass-through chamber minimizes contamination risk by eliminating direct door-opening events during inter-zone transfers. Its operational principle relies on laminar airflow generated by a high-efficiency FFU (Fan Filter Unit) equipped with an H14-grade HEPA filter, delivering unidirectional, particle-free air across the transfer cavity. The integrated DOP (Di-Octyl Phthalate) test port enables quantitative filter integrity verification per ISO 14644-3 Annex B and USP , supporting routine qualification and requalification under FDA 21 CFR Part 211 and EU Annex 1 §4.40–4.44.

Key Features

• Full 304 stainless steel construction—including inner walls, work surface, and structural frame—ensuring corrosion resistance, non-shedding performance, and compliance with pharmaceutical cleaning validation protocols (e.g., residue testing per PDA TR29).
• Radiused internal corners (R ≥ 15 mm) eliminate particle traps and support effective CIP/SIP-compatible wipe-down procedures.
• Dual-sided, tempered double-glazed insulated glass doors with low-emissivity coating reduce thermal bridging and maintain ambient stability; each door integrates mechanical stop limits and position sensors.
• Microprocessor-based electronic interlock system enforces strict sequential operation: Door A must fully close and seal before Door B can be unlocked—preventing simultaneous opening per ISO 14644-7 §6.3.2.
• H14 HEPA filtration (certified ≥99.997% efficiency at MPPS 0.2–0.3 µm) sourced exclusively from Camfil or American Air Filter—traceable via batch-specific test reports compliant with EN 1822-1.
• Adjustable clean cycle timer (0–999 s) with real-time airflow monitoring; UV-C lamp (30 W, 254 nm) activated only when both doors are closed and interlocked.
• Integrated DOP test port (1/4″ NPT female) positioned upstream of the HEPA filter, aligned with ISO 14644-3 Figure B.1 for challenge aerosol injection and downstream scanning.
• Optional differential pressure gauge (0–500 Pa range, ±1.5% FS accuracy) mounted on the exterior panel, calibrated to NIST-traceable standards.

Sample Compatibility & Compliance

This pass-through chamber accommodates rigid, non-powdered, non-sterile primary packaging components (e.g., vial trays, syringe carriers, tooling fixtures) up to 830 mm (W) × 880 mm (H) × 935 mm (D) internal dimensions. It is not intended for sterile product transfer or biological hazard containment. All materials contacting the transfer cavity meet USP Class VI biocompatibility requirements. The unit complies with electromagnetic compatibility per EN 61326-1, electrical safety per EN 61010-1, and is CE-marked under the Low Voltage Directive 2014/35/EU. Documentation includes Factory Acceptance Test (FAT) report, filter certification, interlock logic verification record, and DOP port dimensional drawing—all provided in English upon shipment.

Software & Data Management

The microprocessor controller logs all operational events—including door open/close timestamps, interlock state transitions, UV activation cycles, and clean cycle durations—in non-volatile memory with 12-month retention. Audit trail functionality meets FDA 21 CFR Part 11 requirements for electronic records: user login (role-based access), immutable timestamping, and exportable CSV files via USB interface. No cloud connectivity or remote access is implemented—ensuring data sovereignty and alignment with GxP Annex 11 §5.10 (local storage preference). Calibration certificates for optional DP gauge and UV intensity meter (measured at 1 m distance) are included with initial commissioning documentation.

Applications

• Pharmaceutical aseptic manufacturing suites (fill-finish, isolator loading, component staging)
• Biotechnology cleanrooms handling cell culture media, buffers, and single-use assemblies
• Medical device Class 8 (ISO 14644-1 Class 100,000) assembly areas requiring particulate control
• Research laboratories conducting GLP-compliant stability studies with environmental segregation
• Vaccine production facilities requiring validated barrier transfer between BSL-2 and clean processing zones

FAQ

Is the DOP test port pre-installed and calibrated?
Yes—the port is factory-installed at the designated upstream location and verified for dimensional accuracy and leak-tightness via helium mass spectrometry (leak rate ≤1×10⁻⁹ mbar·L/s). Calibration certificate included.
Can the unit be integrated into a Building Management System (BMS)?
No native BACnet or Modbus interface is provided; however, dry-contact status outputs (door A/B open/closed, interlock fault, UV active) are available for hardwired integration per customer specification.
What maintenance intervals are recommended for HEPA filter replacement?
Filter life is usage-dependent; annual integrity testing via DOP scan is mandatory per ISO 14644-3. Replacement is required if scan reveals >0.01% penetration or after 5 years—whichever occurs first.
Does the unit support IQ/OQ protocol execution?
Yes—full IQ/OQ documentation templates (in English), including test scripts, acceptance criteria, and blank execution records, are supplied with purchase.
Is the UV lamp intensity monitored in real time?
No continuous monitoring is built-in; however, a handheld UV radiometer (254 nm, traceable to NIST) is recommended for quarterly intensity verification per ISO 15858.