Operation and Maintenance of Suppository Dispenser

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository dispenser to ensure accurate dispensing of suppositories during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the dispensing process.
2. Verify the availability and integrity of suppositories ready for dispensing.
3. Inspect the suppository dispenser, including dispensing mechanism, controls, and calibration, to ensure they are clean and in good working condition.

4.2 Dispensing Process

1. Set up the suppository dispenser as per the specifications of the suppository batch.
2. Calibrate the dispenser to ensure accurate dispensing of suppositories based on weight or count.
3. Start the dispensing process and monitor for accurate dispensing into designated containers or packaging.

4.3 Cleaning and Maintenance

1. Stop the dispensing process after completing the batch.
2. Disassemble the dispensing mechanism and clean all parts thoroughly using approved cleaning agents.
3. Perform regular maintenance tasks such as lubrication of moving parts and calibration checks.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository dispenser specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository dispenser

8) SOP Version

Version 1.0