Operation and Maintenance of Suppository Printing Machine

1) Purpose

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

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the printing process.
2. Verify the availability and integrity of suppositories ready for printing.
3. Inspect the suppository printing machine, including ink cartridges and printing heads, to ensure they are clean and properly loaded.

4.2 Printing Process

1. Set up the printing parameters such as printing speed, label position, and ink color according to product specifications.
2. Load the suppositories into the printing machine and start the printing process.
3. Monitor the printing process to ensure accurate placement and quality of printed labels on suppositories.

4.3 Cleaning and Maintenance

1. Stop the suppository printing machine after completing the printing batch.
2. Clean the printing heads, ink cartridges, and conveyor belts thoroughly to remove any ink residues.
3. Perform routine maintenance tasks such as replacement of printing heads and calibration of label alignment.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository labeling specifications

7) Reference, if any

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

8) SOP Version

Version 1.0