HJLCEAN Cleanroom Online Particle Monitoring System | A 7×24-hour Dynamic Compliance Guardian for Clean Environments

With the continuous tightening of industry regulations in pharmaceuticals, biological cell technology, medical devices and other sectors, mandatory requirements have been imposed for dynamic continuous monitoring of suspended particles in Grade A and Grade B clean zones for aseptic production. Suzhou HjClean Tech Co., Ltd. has launched an on-line particle monitoring system for cleanrooms. Leveraging laser light scattering sensing technology, the system enables round-the-clock on-line collection of suspended particles, real-time early warning and full-link data traceability at key locations including clean workshops, aseptic isolators and filling production lines. It complies with domestic and international regulatory standards such as GMP, ISO14644 and EU GMP Annex 1, helping enterprises upgrade from traditional manual spot inspection to dynamic continuous monitoring. The system can detect particulate contamination anomalies in advance to safeguard product manufacturing quality.

The HjClean on-line particle monitoring system adopts a distributed modular architecture, consisting of remote particle sensors, sampling pipelines, data acquisition gateways and compliant monitoring software. The sensor supports simultaneous dual-channel particle counting for 0.5μm and 5.0μm particles and is equipped with constant-flow sampling control to ensure stable sampling flow during long-term operation. The sensor housing is resistant to VHP vaporized hydrogen peroxide sterilization and can be directly deployed in high-risk sterilization areas such as isolators and filling cabins.

The system can be expanded to connect environmental sensors for temperature, humidity, differential pressure, wind speed, viable airborne bacteria and more as required. A single platform integrates all cleanroom environmental parameters to realize centralized integrated monitoring of the clean environment. The system platform features a visual configuration large screen that displays the workshop floor plan, particle concentration at each monitoring point and cleanroom classification status in real time. Custom alert and action limits are supported. In cases of excessive particle concentration, abnormal flow or communication interruption, local audible and visual alarms and remote message notifications will be triggered immediately, allowing maintenance personnel to quickly locate abnormal points and conduct deviation investigations.

The software is developed in accordance with GAMP5 specifications, with built-in complete hierarchical access control, electronic signature and audit trail functions. Raw data cannot be tampered with; historical trend curves are automatically stored, and automatic report generation and PDF/Excel export are supported, fully supporting GMP inspections as well as IQ/OQ/PQ validation activities.

The entire system features flexible networking and supports multiple communication protocols including Ethernet and Modbus. It can connect to existing factory central control platforms such as BMS and SCADA to achieve data interconnection. The layout of monitoring points can be customized according to the cleanroom risk assessment plan. It is applicable to various scenarios including aseptic preparation filling workshops, cell preparation laboratories, medical device clean workshops and monitoring points inside isolators. It suits both new cleanroom construction projects and upgrades of already operational workshops to shorten on-site construction periods.

As a full-service provider of integrated clean system solutions, HjClean delivers one-stop services including preliminary risk assessment, monitoring point design, system integration, on-site installation and commissioning, validation document support and after-sales maintenance. The on-line particle monitoring system, together with the company’s aseptic isolators and VHP sterilization equipment, forms a complete matrix of clean equipment to build an integrated contamination control system for biopharmaceutical enterprises. In the future, Hongji Clean will continue to delve into intelligent monitoring technologies for clean environments, continuously optimize system algorithms and compliance management capabilities, help clean manufacturing enterprises realize digital control of environmental risks and improve workshop quality management standards.