Comprehensive detection solution for clean environment in research institutes

This plan aims to meet the high standard requirements of research institutes for clean environments, integrate advanced detection equipment from Hengmei Company, and construct a comprehensive monitoring system covering suspended particles, microorganisms, bioaerosols, and environmental gases. By scientific deployment, standardized operation, and intelligent analysis, we ensure that the experimental environment continues to comply with international and domestic standards such as ISO 14644 and GMP, providing reliable environmental protection for precision scientific research activities.

Core detection targets and scope

Suspended particle concentration: Monitor the number of dust particles with multiple sizes such as 0.3 μ m, 0.5 μ m, and 5.0 μ m, and evaluate the air cleanliness level (ISO 1-9 levels).

Microbial contamination level: Quantitatively detect the concentration of planktonic bacteria (CFU/m ³) to control the risk of microbial contamination.

Biological aerosol warning: Real time monitoring of potential pathogenic microbial aerosols in the air to enhance biological safety protection capabilities.

Environmental gas safety: Accurate detection of carbon monoxide (CO) concentration to ensure personnel health and experimental safety.

Hengmei Professional Equipment Integration Solution

1. Core monitoring of air cleanliness: Hengmei dust particle counter

Technical advantages: Adopting laser scattering principle, 0.3 μ m high-resolution detection, in compliance with ISO 21501-4 calibration standard.

Execution strategy:

Set up dynamic monitoring points in key areas (clean bench, animal room, reagent preparation area) and calculate the minimum sampling volume according to ISO 14644-1 requirements.

Automatically record particle size distribution data, generate trend curves, and issue real-time alerts for exceeding limits.

Data application: Draw a dynamic map of cleanliness, identify pollution diffusion paths, and optimize airflow organization.

2. Microbial contamination control: Hengmei planktonic bacteria sampler

Technical advantages: Impact sampling method, flow stability error<± 5%, supports multiple culture media.

Execution strategy:

Regular sampling is conducted every month, and monitoring points are added in areas with high personnel activity and equipment vents.

After sampling and culturing for 48-72 hours, accurately calculate CFU/m ³ and compare it with the GMP Annex 1 limit.

Data application: Establish a microbial contamination database, associate personnel operation records, and locate pollution sources.

3. Real time protection for biosafety: Hengmei biological aerosol detector

Technical advantages: Laser induced fluorescence (LIF) technology, second level response, distinguishing between biological and non biological particles.

Execution strategy:

Deploy 24-hour continuous monitoring at the entrance of P2/P3 laboratory and centrifuge operation area.

Set multi-level warning thresholds (such as triggering alarms when biological particles>0.5 μ m suddenly increase by 50%).

Data application: linked with the access control system, automatically activate emergency ventilation in case of abnormalities.

4. Environmental safety baseline guarantee: Hengmei infrared CO analyzer

Technical advantages: NDIR non dispersive infrared technology, 0-1000ppm range, ± 2% FS accuracy.

Execution strategy:

Fixed installation in high-risk areas such as gas equipment rooms and underground floors, with automatic recording every 15 minutes.

Activate the sound and light alarm and exhaust system when exceeding the OSHA limit (35ppm).

Data application: Generate CO concentration heatmap and optimize ventilation system scheduling strategy.

Whole process quality management system

1. Standardized testing process

Develop SOP manual: covering details such as equipment calibration (annual third-party measurement), sampling height (0.8-1.5m), environmental compensation (temperature and humidity recording), etc.

Pre execution verification: three-stage detection of empty state, static state, and dynamic state to eliminate background interference.

2. Intelligent data fusion platform

Establish a unified database, integrate data from four types of devices, and automatically generate PDF/Excel format reports.

Develop visual dashboard: Real time display of environmental risk index (ERI) for each region, calculation formula:

*ERI=(Particle exceedance rate x 0.3)+(Microbial exceedance rate x 0.4)+(CO concentration ratio x 0.3)*

3. Responsive improvement mechanism

Three level response mechanism:

Yellow warning (single parameter critical): retest within 24 hours

Orange alarm (two parameters exceeding the standard): Suspend the use of the area and investigate the HVAC system

Red event (bioaerosol alarm): Activate biosafety emergency plan

Core values of the plan

Multi dimensional protection: covering all aspects from physical particles to biological risks, meeting the dual requirements of GLP/GMP.

Forward looking warning: Real time monitoring of bioaerosols will shift from retrospective monitoring to proactive prevention.

Decision support: Drive management optimization through data association analysis (such as the correlation between particle explosion and personnel flow).

Compliance assurance: The entire process complies with certification requirements such as CNAS-CL01-A025, helping the laboratory to pass the review.

Hengmei Equipment Technical Support:

Dust particle counter: supports 6-channel particle size synchronous analysis, flow rate of 28.3L/min

Floating bacteria sampler: 100L/min high flow sampling, reducing capture time by 50%

Bioaerosol detector: 0.5-10 μ m particle identification, false positive rate<1%

Infrared CO analyzer: temperature compensation algorithm to eliminate drift error

This plan constructs a closed-loop system of "monitoring warning control improvement" for scientific research clean environment through the combination of precision equipment and systematic management, laying a solid foundation for environmental safety for high-level scientific research activities. We can customize graded implementation modules based on specific laboratory layouts and risk levels.

The reliability of scientific data begins with a controlled environment. This plan will help your laboratory establish a solid foundation for scientific research excellence in the basic dimension of clean environment.

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