Standard Operating Procedure for Sterilization Procedures for Manufacturing Equipment

1) Purpose

The purpose of this SOP is to establish guidelines for the sterilization of manufacturing equipment to ensure microbial control and product quality in pharmaceutical manufacturing.

2) Scope

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

3) Responsibilities

3.1 Production Personnel

• Prepare equipment for sterilization according to procedures.
• Operate sterilization equipment safely and effectively.

3.2 Quality Assurance (QA) Personnel

• Verify and validate sterilization processes.
• Review sterilization records and approve equipment release.

4) Procedure

4.1 Equipment Preparation

1. Clean equipment thoroughly to remove visible debris and contaminants.
2. Disassemble equipment components as necessary for effective sterilization.

4.2 Sterilization Methods

1. Select appropriate sterilization method based on equipment type and material compatibility (e.g., steam, dry heat, chemical sterilants).
2. Validate sterilization cycles to ensure effectiveness.

4.3 Sterility Assurance

1. Monitor and record critical parameters during sterilization cycles.
2. Perform biological indicators or other tests to verify sterilization efficacy.

4.4 Post-Sterilization Handling

1. Handle sterilized equipment aseptically to maintain sterility.
2. Store sterilized equipment in designated areas with appropriate environmental controls.

5) Abbreviations, if any

SOP: Standard Operating Procedure; QA: Quality Assurance

6) Documents, if any

• Sterilization Validation Protocols and Reports
• Sterilization Log Records
• Biological Indicator Test Results

7) Reference, if any

USP General Chapter <1211>: Sterilization and Sterility Assurance of Compendial Articles
ISO 13408-1: Aseptic Processing of Health Care Products

8) SOP Version

Version 1.0