SOP for Environmental Monitoring and Control

Standard Operating Procedure for Environmental Monitoring and Control

1) Purpose

This SOP defines the procedures for environmental monitoring in GMP production areas to ensure control of temperature, humidity, air quality, and contamination levels.

2) Scope

This SOP applies to all personnel involved in environmental monitoring in cleanrooms and controlled areas at [Company Name].

3) Responsibilities

Operators: Monitor environmental conditions in cleanrooms and controlled areas, record readings, and report deviations.
Maintenance Team: Ensure that HVAC systems and environmental monitoring equipment are functioning properly and within specifications.
Quality Assurance (QA): Review environmental monitoring logs and investigate deviations.

4) Procedure

4.1 Environmental Monitoring Setup

4.1.1 Equipment Calibration

Ensure that temperature, humidity, and particle counters are calibrated before use. Calibration should be performed at regular intervals according to the manufacturer’s instructions.
Document all calibration activities in the calibration log.

4.1.2 Setting Monitoring Parameters

Set acceptable ranges for temperature, humidity, and air quality based on GMP guidelines and product specifications. These ranges should be documented in the environmental control log.

4.2 Daily Monitoring Activities

4.2.1 Temperature and Humidity Readings

Record temperature and humidity levels in controlled areas at regular intervals (e.g., every four

hours). Ensure that readings fall within the acceptable range for the product being manufactured.

In the event of any deviation, notify supervisors and document the deviation in the environmental monitoring log.

4.2.2 Air Quality and Particle Counts

Measure air quality using particle counters in cleanrooms at least once per shift. Ensure that the particle count does not exceed the allowable limit for the cleanroom classification (e.g., ISO Class 5).
Document the results of the air quality monitoring in the environmental control log and submit for QA review.

4.3 Post-Operation Activities

4.3.1 Documentation

Record all environmental monitoring data in the environmental control log, including temperature, humidity, particle counts, and any deviations. Submit logs to QA at the end of each shift.

4.3.2 Maintenance of Monitoring Equipment

Ensure that all environmental monitoring equipment is cleaned and serviced regularly. Document any maintenance activities in the equipment maintenance log.
Calibrate monitoring devices on a regular schedule to ensure accuracy. Record all calibrations in the calibration log.

5) Abbreviations, if any

GMP: Good Manufacturing Practices
QA: Quality Assurance
HVAC: Heating, Ventilation, and Air Conditioning

6) Documents, if any

Environmental Control Log
Calibration Log
Equipment Maintenance Log

7) References, if any

ISO 14644: Cleanroom Standards
Internal SOP for HVAC maintenance

8) SOP Version

Version 1.0

Annexure

1. Environmental Control Log Template


  
    Date
    Room ID
    Temperature (°C)
    Humidity (%)
    Particle Count (ISO Class)
    Operator Initials
    QA Approval
  
  
    DD/MM/YYYY
    Room Identifier
    Temperature Measured
    Humidity Measured
    Particle Count
    Operator Name
    QA Name

Date	Room ID	Temperature (°C)	Humidity (%)	Particle Count (ISO Class)	Operator Initials	QA Approval
DD/MM/YYYY	Room Identifier	Temperature Measured	Humidity Measured	Particle Count	Operator Name	QA Name