Standard Operating Procedure for Bottling Line

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Bottling Line used in the pharmaceutical manufacturing of otic dosage forms to ensure accurate and sterile bottling of the product.

2) Scope

This SOP applies to all personnel involved in the operation and maintenance of the Bottling Line in the pharmaceutical manufacturing facility.

3) Responsibilities

Operators: Responsible for correctly operating the Bottling Line as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring the accuracy and sterility of the bottling process.
Maintenance Personnel: Responsible for maintaining the Bottling Line in proper working condition.

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Bottling Line 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 Bottling Line and surrounding area.
4.1.2.2 Set up the machine for the required bottle size and volume as per batch requirements.
4.1.2.3 Ensure the filling nozzles and lines are properly sterilized.

4.2 Operation
4.2.1 Bottling Process
4.2.1.1 Start the Bottling Line and ensure it is running smoothly.
4.2.1.2 Place sterilized bottles on the conveyor belt.
4.2.1.3 Monitor the bottling 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 bottles 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 bottling process and ensure all bottles 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 bottling batch
Maintenance records
Calibration records for volume settings

7) Reference, if any

Manufacturer’s manual for the Bottling Line
Pharmacopeial guidelines for pharmaceutical bottling processes

8) SOP Version

Version 1.0