Operation and Maintenance of Ring Sterilization Unit

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the ring sterilization unit to ensure effective sterilization of rings.

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the sterilization chamber and equipment are clean and sanitized before starting the sterilization process.
2. Verify the availability and integrity of rings ready for sterilization.
3. Inspect the sterilization unit, including temperature controls and pressure gauges, to ensure they are functioning correctly.

4.2 Sterilization Process

1. Set up the sterilization parameters such as temperature, pressure, and sterilization cycle time according to product specifications.
2. Load the rings into the sterilization chamber and start the sterilization process.
3. Monitor the sterilization process to ensure all rings are effectively sterilized.

4.3 Cooling and Removal

1. After sterilization is complete, allow the rings to cool down inside the chamber.
2. Once cooled, carefully remove the sterilized rings from the chamber using sterile handling procedures.

4.4 Cleaning and Maintenance

1. After each sterilization batch, clean the sterilization chamber and equipment thoroughly to remove any residues.
2. Perform routine maintenance tasks such as calibration of temperature and pressure gauges, and inspection of seals.

5) Abbreviations, if any

N/A

6) Documents, if any

Sterilization log, Batch production record, Equipment maintenance log

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for sterilization unit

8) SOP Version

Version 1.0