Standard Operating Procedure for Capper

1) Purpose

The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the Capper used in the pharmaceutical manufacturing of otic dosage forms to ensure secure and sterile capping of containers.

2) Scope

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

3) Responsibilities

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

4) Procedure

4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the Capper 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 Capper and surrounding area.
4.1.2.2 Set up the machine for the required cap size as per batch requirements.
4.1.2.3 Ensure the capping heads and lines are properly sterilized.

4.2 Operation
4.2.1 Capping Process
4.2.1.1 Start the Capper and ensure it is running smoothly.
4.2.1.2 Place sterilized containers with filled product on the conveyor belt.
4.2.1.3 Monitor the capping process to ensure secure and sterile sealing.
4.2.1.4 Adjust the cap torque if necessary to maintain seal integrity.

4.2.2 Quality Control
4.2.2.1 Periodically check capped containers for secure seals 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 capping process and ensure all containers are securely sealed.
4.3.1.2 Clean and sanitize the capping heads, 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 capping heads, motors, 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 capping batch
Maintenance records
Calibration records for torque settings

7) Reference, if any

Manufacturer’s manual for the Capper
Pharmacopeial guidelines for pharmaceutical capping processes

8) SOP Version

Version 1.0