Operation and Maintenance of Suppository Cooling Rack

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the suppository cooling rack to ensure effective cooling and solidification of suppositories during the manufacturing process.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before placing suppositories on the cooling rack.
2. Verify the availability and integrity of suppositories ready for cooling.
3. Inspect the suppository cooling rack, including trays and racks, to ensure they are clean and in good working condition.

4.2 Cooling Process

1. Place suppositories on the designated trays of the cooling rack immediately after they are molded.
2. Position the cooling rack in a designated cooling area with controlled temperature and humidity.
3. Allow suppositories to cool and solidify as per the specified time in the manufacturing instructions.

4.3 Cleaning and Maintenance

1. After suppositories are removed, clean the cooling rack thoroughly using approved cleaning agents.
2. Inspect the cooling rack regularly for any signs of wear or damage, and repair or replace parts as necessary.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Suppository cooling rack specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for suppository cooling rack

8) SOP Version

Version 1.0