Standard Operating Procedure for Volumetric Filling Machine
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Volumetric Filling Machine used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and sterile filling of vials.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of the Volumetric Filling Machine in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the Volumetric Filling Machine as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the accuracy and sterility of the filling process.
Maintenance Personnel: Responsible for maintaining the Volumetric Filling Machine in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Volumetric Filling Machine for cleanliness and integrity before use.
4.1.1.2 Ensure all connections, valves, and seals are secure and free of leaks.
4.1.1.3 Verify that all safety devices and interlocks are functioning properly.
4.1.2 Preparation
4.1.2.1 Clean and sanitize the Volumetric Filling Machine and surrounding area.
4.1.2.2 Set up the machine for the required fill volume as per batch requirements.
4.1.2.3 Ensure the filling nozzles and lines are properly sterilized.
4.2 Operation
4.2.1 Filling Process
4.2.1.1 Start the Volumetric Filling Machine and ensure it is running smoothly.
4.2.1.2 Place sterilized vials on the filling line.
4.2.1.3 Monitor the filling process to ensure accurate fill volumes and sterility.
4.2.1.4 Adjust the fill volume if necessary to maintain accuracy.
4.2.2 Quality Control
4.2.2.1 Periodically check filled vials for correct fill volume and absence of contaminants.
4.2.2.2 Document all QC checks and results.
4.2.2.3 Take corrective actions if deviations are observed.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Complete the filling process and ensure all vials are filled correctly.
4.3.1.2 Clean and sanitize the filling nozzles, lines, and machine components.
4.3.1.3 Perform post-operation checks to ensure no residual product or contamination in the machine.
4.3.2 Maintenance
4.3.2.1 Clean and inspect the machine components after each batch.
4.3.2.2 Perform preventive maintenance on valves, pumps, and sensors.
4.3.2.3 Document all maintenance activities and update maintenance records accordingly.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
6) Documents, if any
Batch records for each filling batch
Maintenance records
Calibration records for volume settings
7) Reference, if any
Manufacturer’s manual for the Volumetric Filling Machine
Pharmacopeial guidelines for pharmaceutical filling processes
8) SOP Version
Version 1.0