Operation and Maintenance of Suppository Packaging Machine

1) Purpose

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

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the packaging process.
2. Verify the availability and integrity of packaged suppositories ready for further processing.
3. Inspect the suppository packaging machine, including conveyor belts and sealing mechanisms, to ensure they are clean and operational.

4.2 Packaging Process

1. Set up the packaging parameters such as packaging material type, sealing temperature, and speed according to product specifications.
2. Load the suppositories into the packaging machine and start the packaging process.
3. Monitor the packaging process to ensure proper sealing and labeling of suppositories.

4.3 Cleaning and Maintenance

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

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Packaging material specifications

7) Reference, if any

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

8) SOP Version

Version 1.0