SOP for Maintenance of Environmental Control
Standard Operating Procedure (SOP)
Here’s a comprehensive Standard Operating Procedure (SOP) for the Maintenance of Environmental Control, essential for pharmaceutical, biotech, and cleanroom environments. This SOP ensures the consistent control of environmental parameters such as temperature, humidity, differential pressure, and particulate matter, helping maintain GMP compliance and product quality.
1.0 Objective
To lay down the procedure for maintaining environmental conditions within specified limits in controlled areas to ensure product quality, personnel safety, and regulatory compliance.
2.0 Scope
This SOP applies to all controlled and classified areas (e.g., manufacturing, packing, sampling, and storage areas) within the facility at [Company Name].
3.0 Responsibility
| Role | Responsibility |
|---|---|
| Engineering | Perform maintenance and calibration of HVAC and monitoring equipment |
| QA/QC | Monitor environmental parameters and review records |
| Production | Ensure area cleanliness and report deviations |
| EHS | Support in maintaining environmental health and safety standards |
4.0 Definitions
-
Environmental Control: Monitoring and maintenance of critical parameters like temperature, humidity, pressure, and particulate levels.
-
HVAC: Heating, Ventilation, and Air Conditioning system.
-
Differential Pressure: Pressure difference maintained between adjacent cleanroom areas to avoid contamination flow.
5.0 Parameters to Control and Maintain
| Parameter | Typical Acceptable Range |
|---|---|
| Temperature | 20–25°C (or as defined) |
| Relative Humidity (RH) | 45–65% (or as specified) |
| Differential Pressure | ≥15 Pascal between areas of different classification |
| Airborne Particulate Count | As per ISO 14644 / GMP Grade |
| Microbial Load | As per cleanroom class limits |
6.0 Procedure
6.1 Daily Checks and Monitoring
-
Monitor and record:
-
Temperature & RH using calibrated thermohygrometers.
-
Differential pressure using Magnehelic gauges or digital sensors.
-
Particle count (if applicable) via online or portable particle counters.
-
-
Log data in the Environmental Monitoring Register.
-
Review trends daily; report any deviations immediately.
6.2 Preventive Maintenance
-
Follow the maintenance schedule for:
-
HVAC systems: Filters, dampers, ducting, sensors.
-
AHUs (Air Handling Units): Clean pre-filters weekly and HEPA filters as per validation.
-
Calibration of monitoring instruments as per the calibration schedule.
-
-
Record all maintenance activities in the Maintenance Logbook.
6.3 Deviation Handling
-
In case any parameter is outside the defined limit:
-
Inform Engineering and QA immediately.
-
Raise a Deviation Report.
-
Investigate root cause and initiate corrective actions.
-
-
Document all actions taken and perform impact assessment on product if needed.
6.4 Cleaning of Controlled Areas
-
Follow SOPs for scheduled cleaning (daily/weekly/monthly).
-
Use approved cleaning agents and disinfectants.
-
Document in the Area Cleaning Log.
7.0 Documentation
Maintain the following:
-
Environmental Monitoring Register
-
HVAC Maintenance Log
-
Calibration Certificates
-
Deviation Reports
-
Area Cleaning Records
8.0 Safety and Precautions
-
Only trained personnel to handle HVAC and monitoring equipment.
-
Wear PPE before entering classified areas.
-
Ensure power supply is off before filter or sensor maintenance.
-
Follow lockout/tagout (LOTO) if required.
9.0 Abbreviations
-
SOP: Standard Operating Procedure
-
RH: Relative Humidity
-
HVAC: Heating, Ventilation, and Air Conditioning
-
QA/QC: Quality Assurance / Quality Control
-
PPE: Personal Protective Equipment
10.0 Annexures
-
Annexure 1: Environmental Monitoring Format
-
Annexure 2: Preventive Maintenance Checklist
-
Annexure 3: Deviation Report Template
🎓 Discover one of the best Pharmaceutical Production courses available — click below to explore the course that’s shaping future Production skills.