Operation and Maintenance of Ring Sterilization Chamber

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring sterilization chamber to ensure proper sterilization of rings during the manufacturing process.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the ring sterilization chamber 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 ring sterilization chamber.

4) Procedure

4.1 Preparation

1. Ensure the ring sterilization chamber is clean and free from any residues from previous use.
2. Verify the availability of rings ready for sterilization.
3. Inspect the sterilization chamber, including racks and sterilization controls, to ensure they are clean and in good working condition.

4.2 Sterilization Process

1. Load the rings onto the sterilization racks according to the specified loading pattern.
2. Set the sterilization parameters (e.g., temperature, pressure, duration) as per the validated sterilization cycle.
3. Start the sterilization cycle and monitor the process to ensure proper sterilization of the rings.

4.3 Cleaning and Maintenance

1. After completing the sterilization cycle, allow the chamber to cool down before unloading the sterilized rings.
2. Clean the sterilization chamber thoroughly using approved cleaning agents and procedures.
3. Perform routine maintenance tasks such as checking seals and filters, and calibrating temperature and pressure gauges.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Ring sterilization chamber specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for ring sterilization chamber

8) SOP Version

Version 1.0