Operation and Maintenance of Suppository Capping Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository capping machine to ensure proper sealing and packaging of suppositories.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the suppository capping machine in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the suppository capping machine.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the capping process.
2. Verify the availability and integrity of capped suppositories ready for packaging.
3. Inspect the suppository capping machine, including capping heads and conveyor systems, to ensure they are clean and properly set up.

4.2 Capping Process

1. Set up the capping parameters such as cap placement, torque settings, and sealing pressure according to product specifications.
2. Load the capped suppositories onto the packaging conveyor and start the packaging process.
3. Monitor the packaging process to ensure sealed and labeled suppositories meet quality standards.

4.3 Cleaning and Maintenance

1. Stop the suppository capping machine after completing the packaging batch.
2. Clean the capping heads, conveyor belts, and packaging area thoroughly to remove any residues.
3. Perform routine maintenance tasks such as lubrication of conveyor systems and inspection of capping mechanisms.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository packaging specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository capping machine

8) SOP Version

Version 1.0