Standard Operating Procedure for Particle Counter
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Particle Counter used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and reliable measurement of particulate contamination.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Particle Counter in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Particle Counter as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying particle counts.
Maintenance Personnel: Responsible for maintaining the Particle Counter in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Particle Counter for cleanliness and integrity before use.
4.1.1.2 Ensure that all sensors, sample lines, and connections are intact and functional.
4.1.1.3 Verify that the Particle Counter control system is operational.
4.1.2 Preparation
4.1.2.1 Ensure that the Particle Counter is calibrated according to the manufacturer’s instructions.
4.1.2.2 Set up the Particle Counter according to the specific requirements of the area or equipment to be monitored.
4.1.2.3 Perform a system start-up check as per manufacturer’s instructions.
4.2 Operation
4.2.1 Measurement Process
4.2.1.1 Power on the Particle Counter and select the appropriate measurement program.
4.2.1.2 Position the sample probe in the area or equipment to be monitored.
4.2.1.3 Initiate the measurement cycle, ensuring that all steps are followed as per the selected program (e.g., sample collection, data recording).
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE when handling the Particle Counter and performing measurements.
4.2.2.2 Handle all Particle Counter components with care to prevent damage or contamination.
4.2.2.3 Follow all safety protocols for working with electronic measurement devices.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Disconnect the Particle Counter from the monitored area or equipment.
4.3.1.2 Clean the sample probe and other components according to the manufacturer’s instructions.
4.3.1.3 Power off the Particle Counter and secure it for the next use.
4.3.2 Maintenance
4.3.2.1 Regularly inspect the Particle Counter for wear and tear, and perform necessary repairs.
4.3.2.2 Replace sample lines, sensors, and other consumable components as per the manufacturer’s recommendations.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Measurement records
Calibration records
Maintenance records for the Particle Counter
7) Reference, if any
Manufacturer’s manual for the Particle Counter
Pharmacopeial guidelines for particulate contamination measurement in pharmaceutical manufacturing
8) SOP Version
Version 1.0