Operation and Maintenance of Suppository Inspection Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository inspection machine to ensure thorough inspection of suppositories for quality control purposes.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the inspection process.
2. Verify the availability and integrity of suppositories ready for inspection.
3. Inspect the suppository inspection machine, including lighting systems and conveyor belts, to ensure they are clean and operational.

4.2 Inspection Process

1. Set up the inspection parameters such as inspection speed, magnification, and defect criteria according to product specifications.
2. Load the suppositories onto the inspection conveyor and start the inspection process.
3. Monitor the inspection process to identify any visual defects or irregularities in suppositories.

4.3 Cleaning and Maintenance

1. Stop the suppository inspection machine after completing the inspection batch.
2. Clean the inspection conveyor, lighting systems, and inspection area thoroughly to remove any residue.
3. Perform routine maintenance tasks such as calibration of inspection cameras and replacement of conveyor belts.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository quality control specifications

7) Reference, if any

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

8) SOP Version

Version 1.0