Standard Operating Procedure for Sterilization Procedures for Manufacturing Equipment

1) Purpose

The purpose of this SOP is to outline the procedures for sterilizing manufacturing equipment used in pharmaceutical production to ensure the elimination of microbial contaminants and maintain product quality and safety.

2) Scope

This SOP applies to all personnel involved in the sterilization of manufacturing equipment within the pharmaceutical manufacturing facility.

3) Responsibilities

3.1 Equipment Operators

• Prepare equipment for sterilization following approved procedures.
• Monitor sterilization cycles and ensure equipment readiness.

3.2 Quality Assurance (QA) Personnel

• Verify compliance with sterilization protocols and standards.
• Review and approve sterilization records and documentation.

4) Procedure

4.1 Equipment Preparation

1. Clean equipment thoroughly before sterilization.
2. Disassemble components as necessary for effective sterilization.

4.2 Sterilization Methods

1. Choose appropriate sterilization method (e.g., autoclaving, dry heat, chemical sterilization).
2. Validate sterilization cycles to ensure effectiveness and consistency.

4.3 Sterility Assurance

1. Monitor and record sterilization parameters (time, temperature, pressure, etc.).
2. Perform biological indicators or other tests to verify sterility.

4.4 Equipment Storage and Handling

1. Store sterilized equipment in designated areas under controlled conditions.
2. Handle sterilized equipment using aseptic techniques to prevent recontamination.

5) Abbreviations, if any

QA: Quality Assurance

6) Documents, if any

• Sterilization Validation Reports
• Biological Indicator Results
• Sterilization Logs

7) Reference, if any

USP General Chapter <1211> Sterilization and Sterility Assurance of Compendial Articles
ISO 17665: Sterilization of Health Care Products – Moist Heat

8) SOP Version

Version 1.0