Operation and Maintenance of Suppository Cartoning Machine

1) Purpose

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

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the cartoning process.
2. Verify the availability and integrity of suppositories ready for packaging.
3. Inspect the cartoning machine, including feeding systems and sealing mechanisms, to ensure they are clean and calibrated.

4.2 Cartoning Process

1. Set up the cartoning parameters such as box size, filling quantity, and speed according to product specifications.
2. Load the suppositories into the cartoning machine feeder.
3. Start the cartoning process and monitor to ensure accurate packaging and sealing of suppositories into boxes.

4.3 Cleaning and Maintenance

1. Stop the cartoning machine after completing the packaging batch.
2. Clean the feeding systems, sealing mechanisms, and conveyor belts thoroughly to remove any product residues.
3. Perform routine maintenance tasks such as checking sensors, lubricating moving parts, and inspecting electrical connections.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Cartoning machine specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for cartoning machine

8) SOP Version

Version 1.0