Standard Operating Procedure for Automated Ointment Filling Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Automated Ointment Filling Machine used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and consistent filling of ointments into containers.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Automated Ointment Filling Machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Automated Ointment Filling Machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying the accuracy of ointment filling.
Maintenance Personnel: Responsible for maintaining the Automated Ointment Filling Machine in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Automated Ointment Filling Machine for cleanliness and integrity before use.
4.1.1.2 Ensure that all nozzles, valves, and conveyor belts are clean and free from residue.
4.1.1.3 Verify that the machine is calibrated and operating within specified parameters.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the filling machine and the surrounding area.
4.1.2.3 Ensure that the machine is primed and ready for operation according to manufacturer’s instructions.
4.2 Operation
4.2.1 Filling Process
4.2.1.1 Power on the Automated Ointment Filling Machine and set the filling parameters.
4.2.1.2 Load containers onto the conveyor belt and position them for filling.
4.2.1.3 Initiate the filling process, ensuring that all containers are filled accurately and consistently.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE, including gloves and lab coat, when handling ointment filling operations.
4.2.2.2 Ensure that all machine guards and safety interlocks are in place and functional.
4.2.2.3 Monitor the filling process closely to detect any anomalies or deviations from the set parameters.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the filling process and remove all containers from the machine.
4.3.1.2 Clean and sanitize the filling machine and conveyor belts according to approved procedures.
4.3.1.3 Perform post-operation checks to ensure no residual product or contamination issues.
4.3.2 Maintenance
4.3.2.1 Regularly inspect and clean all parts of the Automated Ointment Filling Machine.
4.3.2.2 Lubricate moving parts as per 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
Maintenance records
Filling logs for the Automated Ointment Filling Machine
Calibration records for the machine
7) Reference, if any
Manufacturer’s manual for the Automated Ointment Filling Machine
Pharmacopeial guidelines for pharmaceutical manufacturing processes
8) SOP Version
Version 1.0