Guolin Health GL-AD-T-400S Electrolytic Ozone Generator for Pharmaceutical, Food & Laboratory Air Disinfection

Overview

The Guolin Health GL-AD-T-400S is an electrolytic ozone generator engineered specifically for controlled air disinfection in regulated laboratory, pharmaceutical manufacturing, food processing, and healthcare environments. Unlike corona discharge-based systems, this unit employs solid polymer electrolyte (SPE) membrane electrolysis — a process that splits deionized water into high-purity ozone (O₃), oxygen (O₂), and hydrogen (H₂) at the anode without nitrogen oxide byproducts. The resulting ozone gas is delivered at concentrations up to 10 g/h, with precise digital regulation across the full output range. Its dual cooling architecture (integrated air and water cooling) ensures thermal stability during extended 24-hour operation — critical for continuous cleanroom recirculation or HVAC-integrated sterilization protocols. As a Class II medical device-supporting auxiliary system, it complies with design principles aligned with ISO 13485 quality management frameworks and supports validation pathways under EU Annex 1 and USP <1072> guidelines for ozone use in sterile processing.

Key Features

• Electrolytic ozone generation via SPE membrane technology — zero NOₓ emissions, >90% ozone purity in dry air stream
• Digital concentration control with real-time feedback loop; adjustable output from 0 to 10 g/h in 0.5 g/h increments
• Stainless steel 304 enclosure with IP54-rated ingress protection; corrosion-resistant internal wetted parts
• Multi-stage gas filtration: particulate pre-filter + activated carbon + desiccant dryer — extends membrane life and maintains output consistency
• Integrated dual-mode cooling: low-noise axial fans combined with sealed water-circulation loop for sustained thermal management
• Wi-Fi–enabled remote interface supporting scheduled operation, runtime logging, and alarm notifications via iOS/Android application
• Compliance-ready data architecture: audit trail logging (on-device SD card backup), timestamped event records, and user-access levels

Sample Compatibility & Compliance

The GL-AD-T-400S is intended for integration into air handling units (AHUs), laminar flow cabinets, isolators, and dedicated disinfection chambers. It delivers ozone into ambient or recirculated airstreams with flow rates compatible with standard ducting (recommended max. 300 m³/h). While not a standalone sterilizer, it functions as a validated environmental bioburden reduction tool when deployed per ISO 14644-1 Class 5–8 space conditioning protocols. Device firmware supports 21 CFR Part 11–compatible electronic signatures when paired with compliant LIMS or MES platforms. All electrical safety certifications conform to GB 4793.1–2019 (equivalent to IEC 61010-1), and ozone emission limits adhere to GB/T 28232–2011 (ozone occupational exposure ≤ 0.1 ppm averaged over 8 h).

Software & Data Management

The embedded controller runs on a real-time OS with secure OTA update capability. The companion mobile application provides role-based access (Operator, Supervisor, Administrator), enabling configuration of daily disinfection cycles, manual override, and historical ozone dose tracking. All operational parameters — including output setpoint, actual concentration (via integrated electrochemical sensor), runtime, cooling temperature, and filter service alerts — are logged with UTC timestamps. Local storage retains ≥30 days of compressed event data; optional cloud sync (AWS IoT Core–certified) enables centralized fleet monitoring across multi-site GMP facilities. Export formats include CSV and PDF reports suitable for regulatory review or internal QA audits.

Applications

• Pharmaceutical: Pre-sterilization chamber purging, HVAC duct sanitization between batch cycles, and aseptic suite air quality maintenance
• Food & Beverage: Cold room decontamination, packaging line ambient air treatment, and CIP rinse water ozonation support
• Research Laboratories: Biosafety Level 2 (BSL-2) containment area deactivation, glovebox atmosphere refresh, and instrument enclosure sterilization
• Healthcare: Operating theatre air reconditioning post-procedure, isolation room terminal disinfection, and medical device storage cabinet sanitation
• Drinking Water Facilities: Pilot-scale dissolved ozone dosing validation and distribution system biofilm suppression trials

FAQ

Is this unit suitable for direct surface disinfection?
No — the GL-AD-T-400S is designed exclusively for gaseous-phase air and duct-stream treatment. Surface disinfection requires contact time and humidity control beyond its operational scope.
What maintenance intervals are recommended?
Pre-filters require replacement every 3 months under continuous use; SPE membrane service life is rated for ≥12,000 hours with proper inlet air conditioning and regular desiccant regeneration.
Can it be integrated with building management systems (BMS)?
Yes — Modbus RTU (RS-485) and optional BACnet/IP interfaces are available upon request for OEM integration into facility-wide control networks.
Does ozone output require calibration verification?
Yes — users must perform quarterly verification using a NIST-traceable UV photometric ozone analyzer (e.g., 2B Technologies Model 106-M) per ISO 17025–accredited procedures.
Is operator training provided?
Guolin Health offers remote technical induction and GMP-compliant SOP development support for qualified QA/QC personnel; onsite validation assistance is available under separate service agreement.