Shanghai Hujing APB-557 Stainless Steel Pass-Through Chamber

Overview

The Shanghai Hujing APB-557 Stainless Steel Pass-Through Chamber is an engineered solution for controlled material transfer between adjacent cleanroom zones—specifically between ISO Class 5 (Fed. Std. 209E Class 100) environments or between classified and non-classified areas. It operates on the principle of laminar air displacement: a vertically oriented, downward-directed airflow—generated by a low-noise centrifugal blower and conditioned through a certified HEPA filter (H13 grade, 99.99% @ 0.3 µm)—creates a particle-swept barrier across the transfer cavity. This airflow prevents cross-contamination by maintaining positive pressure differential and minimizing turbulent mixing during brief door openings. The unit is not a standalone cleanroom but a critical auxiliary component in pharmaceutical manufacturing suites, medical device assembly lines, semiconductor packaging labs, and biotechnology R&D facilities where regulatory adherence to ISO 14644-1, EU GMP Annex 1, and FDA CGMP requires strict control of particulate ingress during routine material exchange.

Key Features

• 304 stainless steel construction throughout—interior walls, ceiling, floor, and frame—with seamless welding and radius-rounded internal corners (R ≥15 mm) to eliminate particle traps and support validated cleaning protocols.
• Dual-door mechanical and electrical interlock system: physically prevents simultaneous opening; triggers immediate fan startup upon detection of either door actuation, ensuring continuous airflow before item entry or exit.
• Integrated UV-C germicidal lamp (254 nm wavelength, ≥10,000 µW/cm² irradiance at 1 m) activated concurrently with fan operation—providing surface decontamination of transferred items and interior surfaces during idle cycles.
• LED task lighting (cool white, 4000 K CCT, 12 V DC) synchronized with fan runtime, offering uniform illumination without thermal load or electromagnetic interference.
• HEPA filter housed in a gasketed, easily accessible drawer-type module—designed for field replacement without tools and compatible with standard filter integrity testing (e.g., DOP/PAO scanning per ISO 14644-3).
• No external control panel or touchscreen—minimizes contamination risk and simplifies qualification (IQ/OQ) under GMP environments where firmware validation is avoided.

Sample Compatibility & Compliance

The APB-557 accommodates rigid or semi-rigid objects up to 420 mm (W) × 480 mm (D) × 400 mm (H), including stainless steel trays, sealed sample containers, tooling fixtures, and pre-sterilized packaging. It is unsuitable for aerosol-generating items, open liquids, or heat-sensitive materials requiring temperature-controlled transfer. Regulatory alignment includes design conformance to ISO 14644-1:2015 (airborne particle concentration limits), ISO 14644-3:2019 (test methods for airflow uniformity and filter leakage), and IEC 60335-1 safety requirements for electrical equipment. While not intrinsically compliant with FDA 21 CFR Part 11 (as it lacks electronic audit trails), its passive architecture supports integration into Part 11–compliant facility-wide MES or SCADA systems via discrete I/O signals (e.g., door status, fan run feedback).

Software & Data Management

This pass-through chamber operates without embedded software, firmware, or network connectivity—eliminating cybersecurity risks and reducing validation burden in regulated settings. All operational states (fan on/off, UV lamp status, door position) are conveyed via dry-contact relay outputs (NO/NC, 24 V DC), enabling direct interfacing with building management systems (BMS), PLCs, or centralized monitoring platforms. No local data logging occurs; however, when connected to a validated facility data acquisition system, event timestamps (e.g., door open duration, cumulative fan runtime) can be recorded for trend analysis and periodic review per ISO 13485 clause 7.5.10 or EU GMP Annex 11 Annex A.

Applications

• Pharmaceutical aseptic processing: transfer of stoppered vials, syringes, and isolator gloves between Grade A and Grade B zones.
• Medical device manufacturing: movement of sterilized components into Class 100 laminar flow hoods without compromising ISO 13485 process controls.
• Cell therapy labs: handling of cryovials and biosafety cabinets while maintaining ISO 5 environmental integrity during CAR-T workflow transitions.
• Microelectronics cleanrooms: conveyance of photomasks and wafer carriers between yellow-room and metrology bays under ISO 14644-1 Class 5 specifications.
• Vaccine development facilities: secure exchange of QC samples between biosafety level 2 (BSL-2) preparation rooms and analytical laboratories.

FAQ

Does the APB-557 meet ISO Class 5 (100) certification requirements?
Yes—the unit achieves and maintains ISO Class 5 performance when installed with proper upstream air supply, downstream exhaust balancing, and verified HEPA filter integrity per ISO 14644-3 test protocols.
Can the UV lamp be operated independently of the fan?
No—UV activation is hardwired to fan operation per IEC 62471 photobiological safety requirements to prevent human exposure to unshielded germicidal radiation.
Is the HEPA filter replaceable onsite without specialized tools?
Yes—the filter slides into a front-access drawer with silicone gasket sealing; replacement takes <5 minutes and requires no torque calibration or re-balancing.
What electrical certifications does the unit carry?
It complies with GB 4706.1 (China national standard equivalent to IEC 60335-1) and carries CCC mark; CE marking is available upon request for EU export configurations.
How is validation supported for GMP environments?
The unit ships with Factory Acceptance Test (FAT) documentation including airflow velocity mapping, interlock verification report, and HEPA filter DOP scan certificate—serving as baseline evidence for IQ/OQ execution.