Zhicheng ZHJH-C1118C Intelligent Safety Clean Bench with HEPA Failure Alarm

Overview

The Zhicheng ZHJH-C1118C Intelligent Safety Clean Bench is a vertically downflow laminar airflow workstation engineered for ISO Class 5 (FS209E Class 100) environments. It operates on the principle of unidirectional airflow: ambient air is drawn through a washable pre-filter, pressurized by a high-efficiency centrifugal fan, and then passed through a certified HEPA filter (≥99.995% efficiency at 0.3 µm). The resulting particle-free airstream descends uniformly across the 1800 mm wide work surface at a precisely regulated velocity between 0.3–0.6 m/s—ensuring consistent protection of both operator and sample from airborne contamination. Unlike conventional clean benches, the ZHJH-C1118C integrates real-time HEPA integrity monitoring via differential pressure sensing, enabling proactive detection of filter degradation, physical breach, or performance drift—critical for GLP-compliant laboratories where documentation of environmental control is mandatory.

Key Features

• Real-time HEPA health monitoring: continuous differential pressure measurement (0–500 Pa range, ±1% FS accuracy) with automatic visual, audible, and bilingual (Chinese-English capable) alerts upon threshold exceedance
• Infinitely adjustable and closed-loop stabilized airflow: user-defined setpoints from 0.1–1.0 m/s; actual velocity displayed with 0.1 m/s resolution and maintained within ±0.05 m/s tolerance
• Programmable UV sterilization: configurable start/stop timing for quartz germicidal lamps (253.7 nm), supporting pre-use decontamination protocols aligned with USP & ISO 14644-1 Annex B requirements
• Electropolished 304 stainless steel work surface with seamless radiused corners—designed for chemical resistance, ease of disinfection, and compliance with FDA 21 CFR Part 11 audit trail prerequisites when paired with optional data logging firmware
• Counterbalanced vertical sash and dual-side tempered glass viewing panels: provide ergonomic access, optical clarity, and structural containment without compromising illumination (≥300 lx uniformity)
• Embedded cumulative runtime counter and clock function: supports preventive maintenance scheduling per ISO/IEC 17025 Clause 6.4.8 and internal QA recordkeeping
• Low-noise operation (≤62 dB[A]) and vibration-damped chassis (≤4 µm half-amplitude): essential for micro-manipulation tasks and sensitive instrumentation placement adjacent to the unit

Sample Compatibility & Compliance

The ZHJH-C1118C accommodates standard microbiological culture plates (90 mm), tissue culture flasks, PCR workstations, and small-scale sterile assembly operations. Its vertical downflow architecture minimizes turbulence-induced cross-contamination during aseptic transfers—validated per ISO 14644-3:2019 Annex D for particle challenge testing. The unit meets national safety standards GB/T 25915.1–2021 (equivalent to ISO 14644-1) for cleanroom classification and complies with YY 0569–2011 (Chinese medical device standard for biological safety cabinets and clean benches). While not classified as a biosafety cabinet (BSC), its HEPA alarm functionality satisfies risk mitigation requirements outlined in CLSI M29-A4 for non-contained microbial handling in low-risk applications.

Software & Data Management

The integrated LCD interface provides real-time quantitative readouts of airflow velocity, HEPA ΔP, cumulative runtime, and lamp operational status—all logged internally with timestamping. Optional RS-485 or USB-C output enables integration into centralized laboratory monitoring systems (LMS) for automated CSV export. When deployed in regulated environments, the system supports ALCOA+ data integrity principles: attributable (user ID tag), legible (backlit display), contemporaneous (real-time stamping), original (non-erasable memory buffer), accurate (calibrated sensors), complete (full parameter history), consistent (sequential logging), enduring (10-year EEPROM retention), and available (export-ready format). Audit trail generation aligns with FDA 21 CFR Part 11 electronic records provisions when used with validated third-party LMS platforms.

Applications

This clean bench serves routine aseptic procedures in pharmaceutical QC labs (e.g., media fill simulations, raw material sampling), academic cell culture facilities, clinical diagnostic support units processing non-infectious specimens, environmental microbiology labs conducting water/air viability assays, and electronics manufacturing cleanrooms requiring particulate-free soldering or component inspection. Its programmable UV cycle and HEPA alarm capability make it particularly suitable for facilities transitioning from manual logbook-based maintenance to digitally auditable workflows under ISO 13485 or GMP Annex 1 revision drafts.

FAQ

Does the ZHJH-C1118C meet ISO Class 5 certification requirements?
Yes—the unit achieves and maintains ≤3.5 particles/L (≥0.5 µm) in the work area under steady-state operation, verified per ISO 14644-3:2019 test methods.
Can HEPA filter status data be exported for regulatory audits?
Internal logs are viewable on-screen; optional serial/USB interface enables export of time-stamped ΔP, velocity, and alarm events in CSV format for inclusion in QA documentation.
Is the UV lamp intensity monitored or calibrated?
The system tracks lamp operating hours and enforces scheduled replacement intervals; spectral output verification requires external radiometric calibration per IEC 62471.
What maintenance intervals are recommended for the pre-filter and HEPA?
Pre-filter cleaning every 2 weeks under normal use; HEPA replacement every 12–24 months depending on ambient particulate load—triggered automatically when ΔP exceeds 450 Pa.
Does the unit support integration with building management systems (BMS)?
Via optional Modbus RTU or BACnet MS/TP gateway modules, enabling remote status polling and HVAC interlock signaling for lab-wide environmental coordination.