Standard Operating Procedure for Cleanroom Monitoring System
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the cleanroom monitoring system in the pharmaceutical manufacturing of otic dosage forms to ensure controlled and compliant cleanroom conditions.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the cleanroom monitoring system in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the cleanroom monitoring system as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying cleanroom conditions.
Maintenance Personnel: Responsible for maintaining the cleanroom monitoring system in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the cleanroom monitoring system for cleanliness and integrity before use.
4.1.1.2 Ensure that all sensors, displays, and connections are intact and functional.
4.1.1.3 Verify that the monitoring control system is operational.
4.1.2 Preparation
4.1.2.1 Ensure that the cleanroom monitoring system is set to the required parameters for temperature, humidity, and particle count.
4.1.2.2 Check that all sensors and monitoring equipment are calibrated and functional.
4.1.2.3 Perform a system start-up check as per manufacturer’s instructions.
4.2 Operation
4.2.1 Monitoring Cleanroom Conditions
4.2.1.1 Power on the cleanroom monitoring system and initiate the monitoring process.
4.2.1.2 Continuously monitor the temperature, humidity, and particle count to ensure they remain within specified limits.
4.2.1.3 Record cleanroom conditions at regular intervals as per the monitoring protocol.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE when inspecting or maintaining the cleanroom monitoring system.
4.2.2.2 Handle all cleanroom monitoring components with care to prevent damage or contamination.
4.2.2.3 Follow all safety protocols for working with electrical and monitoring systems.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Power off the cleanroom monitoring system after completing the operation.
4.3.1.2 Clean the sensors and displays if necessary.
4.3.1.3 Secure the system for the next use.
4.3.2 Maintenance
4.3.2.1 Regularly inspect the cleanroom monitoring system for wear and tear, and perform necessary repairs.
4.3.2.2 Replace 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
Cleanroom monitoring records
Maintenance records for the cleanroom monitoring system
7) Reference, if any
Manufacturer’s manual for the cleanroom monitoring system
Pharmacopeial guidelines for cleanroom monitoring in pharmaceutical manufacturing
8) SOP Version
Version 1.0
