Standard Operating Procedure for Clean Room Particle Counter

1) Purpose

The purpose of this SOP is to provide guidelines for the operation and calibration of the Clean Room Particle Counter used in the clean room environment for manufacturing ocular dosage forms.

2) Scope

This SOP applies to all Clean Room Particle Counters used to monitor airborne particulate contamination levels in clean rooms during the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, calibration, and maintenance of the Clean Room Particle Counter. Facility engineers are responsible for following this procedure, and the maintenance team is responsible for calibration and periodic checks.

4) Procedure

4.1 Start-Up Procedure

1. Ensure the Clean Room Particle Counter is properly installed and calibrated.
2. Verify that the counter displays zero particles when no sampling is performed.
3. Record the initial readings of particle counts for each clean room area.

4.2 Operation

1. Perform routine particle counting according to the sampling plan and schedule.
2. Follow the manufacturer’s instructions for sample collection and analysis.
3. Record particle counts and any deviations from specified limits.

4.3 Calibration

1. Calibrate the Clean Room Particle Counter annually or as per the manufacturer’s recommended schedule.
2. Use calibrated standard particles and follow documented procedures for calibration.
3. Record calibration results and adjustments made in the calibration logbook.

4.4 Maintenance

1. Perform regular inspections to ensure the Clean Room Particle Counter is clean and free from physical damage.
2. Replace filters and other consumable parts as recommended by the manufacturer.
3. Document any maintenance activities performed in the logbook.

5) Abbreviations, if any

None

6) Documents, if any

1. Calibration logbook
2. Maintenance records

7) Reference, if any

GMP Guidelines for pharmaceutical manufacturing facilities and clean room environmental monitoring.

8) SOP Version

Version 1.0