Operation and Maintenance of Ring Sterilizer

1) Purpose

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

2) Scope

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

4) Procedure

4.1 Preparation

1. Ensure the work area 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 ring sterilizer, including sterilization chamber and controls, to ensure they are clean and in good working condition.

4.2 Sterilization Process

1. Load the rings into the sterilization chamber according to the recommended loading pattern.
2. Set the sterilization parameters such as temperature, pressure, and duration based on sterilization requirements.
3. Initiate the sterilization cycle and monitor the process to ensure all rings are effectively sterilized.

4.3 Cooling and Removal

1. Once the sterilization cycle is complete, allow the sterilizer to depressurize and cool down.
2. Remove sterilized rings from the chamber using sterile handling procedures.
3. Clean the sterilization chamber and associated components after each cycle to maintain cleanliness.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Ring sterilizer specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for ring sterilizer

8) SOP Version

Version 1.0