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The core points of the automatic control system for clean workshops (FMCS)
2026/5/13
Precise control of environmental parameters:
Temperature and humidity: According to process requirements, ±0.5℃ to ±1℃ (temperature), ±5% RH (humidity). No condensation. Cleanliness: Real-time monitoring of particle concentration (0.5μm/5μm), linkage of fresh air / filtration system pressure difference: Positive pressure in the clean area compared to the non-clean area (10 to 30 Pa). Controllable pressure gradient in key areas. Anti-cross-contamination air change rate: Set according to cleanliness level (Class 100 to 100,000 corresponding to 15 to 60 times/h)
2. System Security and Stability:
Redundant design: Redundant configuration for key controllers, sensors, fans / pumps Fault alarm: Parameter exceeds limit, equipment failure (such as filter blockage) Real-time warning + graded handling Interlock protection: Fire linkage (cut off non-essential equipment), power outage emergency (switch to backup power supply)
II. Core Control Module (Function Focus)
HVAC System Control (Core):
Fresh air / return air / exhaust air ratio regulation (energy saving + cleanliness balance) air conditioning unit: Variable frequency control (VFD) fan / pump, PID regulation for temperature and humidity (cooling water valve, steam valve, humidifier) Filter system: Primary / medium / high-efficiency filters with pressure difference monitoring, prompt for replacement when exceeding the limit
2. Special Control of Cleanrooms:
Pressure difference control: The air volume is adjusted by the electric air valve to maintain the set pressure difference. Particle monitoring: The online particle counter samples in real time, and the data is uploaded + abnormal linkage. New air supply personnel / material channels: The air shower room is interlocked (no air shower, cannot enter), and the pressure difference of the transfer window is monitored.
3. Auxiliary System Interconnection:
Process Cooling Water (PCW): Temperature/pressure control, linked with the air conditioning system. Compressed air: Dew point/pressure monitoring, sent to the clean area upon meeting standards. Lighting / illumination: Human sensing + timed control, with energy conservation as the priority.
III. Key Considerations for Hardware Selection (Stability + Compliance)
Controller:
Using PLC/DCS distributed control, it supports Modbus/BACnet protocols, facilitating the integration of local independent operation of key area controllers with centralized monitoring, preventing single-point failures.
2. Sensor:
Temperature and humidity: High accuracy (±0.3℃/±2% RH), anti-interference, installed in the stable airflow area. Pressure difference: Micro-pressure sensor (range 0 - 100 Pa), anti-condensation design. Particle counter: Compliant with ISO 21501-4, supports real-time data upload.
3. Execution Agency:
Valve: Electrically adjustable type, with excellent sealing performance (leakage rate ≤ 2%)
Pumps / Fans: Variable frequency drive (VFD), suitable for load changes
Valves: Proportional integral regulation, corrosion-resistant (for acid-base processing areas)
IV. Core Requirements for Software and Monitoring
Central Monitoring and Control Platform (SCADA):
Real-time visualization: Process flow, parameter curves, equipment status (distinguished by color for normal / alarm) Data management: Historical data storage for at least 1 year (in compliance with GMP traceability requirements), supports export / audit tracking. User permissions: Hierarchical authorization (Administrator / Operator / Maintenance), operation logs are retrievable.
2. Control Logic:
Adaptive adjustment: Automatically adjust parameters based on load changes (such as personnel addition or reduction, process heat generation). Energy-saving strategy: Run at low load during night or holidays, and adjust the fresh air volume as needed (based on CO₂ concentration). Interlock logic: If the fan fails → automatically switch to the backup unit; if there is a fire alarm → shut off the fresh air / exhaust air, and start the smoke exhaust.
V. Key Points of Compliance and Verification (GMP/ISO)
1. Design Compliance:
Compliant with GMP Annex 1 (for sterile drugs) and ISO 14644 (for clean rooms) requirements for electrical system: Class I Div 2 (hazardous area) explosion-proof design, with reliable grounding
2. Verification Process:
Installation Confirmation (IQ): Equipment model, installation location, correct wiring
Operation Qualification (OQ): Parameter control accuracy, interlock function, alarm response performance
Process Qualification (PQ): Verification of environmental parameter stability during 3 consecutive batches of production
VI. Key Points of Operation and Maintenance
Regular calibration: Sensors (every 6 to 12 months), actuators (every quarter) - calibration is conducted, results are recorded and archived.
2. Preventive Maintenance: Monitoring of filter pressure difference (replace immediately upon exceeding the limit), lubrication and maintenance of fans / pumps
3. Emergency Response: Rapid switching of backup systems, standardization of fault detection procedures
