Hospitals & Laboratories HR-FMS Online Monitoring System Solution

Compliant with ISO 14644 / ASHRAE 170 / EU GMP Annex 1 Standards

1. SOLUTION OVERVIEW

The HR-FMS Online Monitoring System by Honri Purification is specifically designed for high-risk areas such as operating rooms, ICUs, negative pressure isolation wards, PCR laboratories, biosafety labs, and sterility testing rooms. The system provides 7×24H automated online monitoring of suspended particles, viable organisms, temperature, humidity, differential pressure, air velocity, illuminance, and chemical pollutants (TVOC).

2. CORE DESIGN PRINCIPLES

2.1 Risk-Based Classification & Sampling Design (ISO 14644-1)

• Zoned Monitoring Strategy: Differentiated monitoring plans are implemented for areas with different risk levels, such as Operating Rooms (ISO Class 5), PCR Lab Amplification Zones (ISO Class 7), and ICUs (ISO Class 6).

• Sampling Location Calculation: For high-risk areas, the minimum number of sampling locations (NL) is calculated strictly using the standard formula:

NL = √A

Parameters:

• NL: Minimum number of sampling locations (rounded up to the next whole number).

• A: Cleanroom area (Unit: m²).

• Priority for Critical Workstations: At least one monitoring point is placed at core exposure areas such as directly above the operating table, sample processing benches, and aseptic filling stations.

• Standardized Positioning: Sampling probes are set at a uniform height of 0.8–1.2 m; locations must be ≥ 30 cm from walls and ≥ 1 m from HEPA filters to ensure representative data.

2.2 Airflow & Microbial Control (ISO 14644-4 / ASHRAE 170)

• Isokinetic Sampling: Probes in unidirectional flow areas (e.g., laminar flow ORs) must be equipped with isokinetic sampling heads to match the air velocity of 0.36–0.54 m/s.

• Pressure Gradient Specifications: Ensures a differential pressure of ≥ 15 Pa between clean and non-clean zones, and ≥ 5 Pa between zones of the same grade to effectively prevent cross-contamination.

2.3 Data Compliance & Traceability (21 CFR Part 11)

• Audit Trail: The system logs all parameter modifications, alarm acknowledgments, and data exports, ensuring the data is authentic, tamper-proof, and traceable throughout its lifecycle.

3. CORE HARDWARE CONFIGURATION

4. SOFTWARE SYSTEM CAPABILITIES

• Multi-Zone & Multi-Standard Monitoring: Displays data grouped by department or lab type; interfaces can be customized for facility management or research oversight.

• Hierarchical User Rights: Configurable access for Administrators, Department Heads, and Operators with electronic signature support.

• Intelligent Alerts: Thresholds can be customized per international standards; alerts are sent via local sirens, SMS, and mobile APP notifications.

• Compliance Reporting: Data is categorized and stored to generate encrypted PDF reports, meeting long-term archival requirements for hospital accreditation.

• Seamless Integration: Supports RS485, WiFi, and TCP/IP for direct connection to Hospital Information Systems (HIS) or Laboratory Information Management Systems (LIMS).

5. STRATEGIC VALUE

1. International Compliance: Assists hospitals in achieving JCI Accreditation and labs in securing CNAS/ILAC recognition.

2. Precision Risk Control: Real-time monitoring of high-risk parameters reduces post-operative infection rates and sample cross-contamination.

3. Research Quality Assurance: Provides continuous, accurate, and tamper-proof environmental data to support the reliability of scientific results.

4. Energy Efficiency: Aligns with ISO 14644-16 to optimize ventilation system operation based on data analysis, reducing energy costs.

Solution Provider: Suzhou Honri Purification Technology Co., Ltd. (Suzhou Honri Purification)