ISO 14644 HR-FMS Cleanroom Online Monitoring System Solution

7×24H Automated Environmental Compliance & Risk Management

1. SOLUTION OVERVIEW

The HR-FMS Cleanroom Online Monitoring System by Honri Purification provides a comprehensive, 24/7 automated solution for monitoring critical environmental parameters. Developed in strict accordance with the ISO 14644 series (including ISO 14644-1 for classification and ISO 14644-4 for airflow design), the system tracks suspended particles, viable organisms, temperature, humidity, differential pressure, and air velocity.

2. CORE COMPLIANCE PRINCIPLES

2.1 Scientific Classification & Sampling Design (ISO 14644-1)

• Sampling Location Calculation: The minimum number of sampling locations ($N_L$) is determined by the standard ISO 14644-1 formula:

NL = √A

Parameters:

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

• A: Area of the cleanroom in m².

• Positioning Requirements: Sampling probes are positioned 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 Integrity Control (ISO 14644-4)

• Unidirectional Flow Monitoring: Ensures ISO Class 5 (Grade A) zones maintain a stable air velocity between 0.36–0.54 m/s.

• Isokinetic Sampling: Grade A zones are equipped with isokinetic sampling heads to ensure intake velocity matches the laminar airflow, preventing air turbulence and ensuring count accuracy.

2.3 Data Integrity & Traceability (21 CFR Part 11)

• Audit Trail: Full compliance with electronic record and signature requirements. Ensures the entire data lifecycle—from collection to export—is tamper-proof and traceable (ALCOA+).

3. CORE HARDWARE CONFIGURATION

4. SOFTWARE SYSTEM CAPABILITIES

• Static & Dynamic Modes: Supports both “At-rest” classification and “In-operation” routine monitoring.

• 3-Level User Rights: Strict access control for Administrators, Engineers, and Operators with full action logging.

• Intelligent Alarms: Real-time notifications via local sirens, SMS, and mobile APPs based on ISO 14644 limits.

• Automated Reporting: Generates encrypted PDF reports compliant with regulatory audits at the click of a button.

• Seamless Integration: Supports RS485 (MODBUS), TCP/IP, and WiFi for easy connection to LIMS or MES systems.

5. STRATEGIC VALUE

1. Guaranteed Compliance: Fully aligned with international ISO 14644 and GMP regulatory frameworks.

2. Operational Efficiency: 7×24H automated monitoring replaces manual labor and eliminates human error.

3. Proactive Risk Control: Immediate detection of environmental drifts prevents product contamination and downtime.

4. Turnkey Implementation: Comprehensive service including layout design, Validation (IQ/OQ/PQ), and calibration.

Manufactured by: Honri Airclean Technology (Suzhou) Co., Ltd.