Operation and Maintenance of Suppository Printer

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository printer to ensure accurate printing of labels or markings on suppositories during the manufacturing process.

2) Scope

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

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 printer, including printing heads, conveyors, and controls, to ensure they are clean and in good working condition.

4.2 Printing Process

1. Set up the suppository printer as per the specifications of the printing design.
2. Load the printing data or template into the printer system.
3. Start the printing process and monitor for accurate placement of labels or markings on suppositories.

4.3 Cleaning and Maintenance

1. Stop the printing process after completing the batch.
2. Perform regular cleaning of printing heads and conveyors using approved cleaning agents.
3. Inspect and lubricate moving parts as per the maintenance schedule.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository printer specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository printer

8) SOP Version

Version 1.0