Operation and Maintenance of Suppository Molding Tray

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository molding tray to ensure proper molding of suppositories during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the suppository molding tray is clean and sanitized before use.
2. Verify the availability of suppository mass ready for molding.
3. Inspect the molding tray, including molds and cooling systems, to ensure they are clean and in good working condition.

4.2 Molding Process

1. Prepare the suppository mass according to the formulation specifications.
2. Load the molds of the molding tray with the prepared suppository mass.
3. Initiate the molding process and monitor the tray for the formation of suppositories.

4.3 Cleaning and Maintenance

1. After completing the molding process, remove the suppositories from the molds.
2. Clean the molding tray thoroughly using approved cleaning agents and procedures.
3. Perform regular maintenance tasks such as checking mold alignment and lubricating moving parts.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository molding tray specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository molding tray

8) SOP Version

Version 1.0