Standard Operating Procedure for Sterilization of Manufacturing Equipment

1) Purpose

The purpose of this SOP is to define the procedures for sterilizing manufacturing equipment to ensure a sterile production environment and prevent contamination of injection products.

2) Scope

This SOP applies to all personnel involved in the sterilization of manufacturing equipment at [Company Name] used for the production of intramuscular, subcutaneous, and intravenous injection products.

3) Responsibilities

The responsibilities of this SOP include:
– Production Department: Performing sterilization of manufacturing equipment.
– Quality Control (QC) Department: Testing and verifying the effectiveness of sterilization.
– Quality Assurance (QA) Department: Reviewing and approving sterilization procedures and records.

4) Procedure

4.1 Preparation for Sterilization
4.1.1 Clean all equipment thoroughly to remove any visible debris or residues.
4.1.2 Inspect equipment to ensure it is in good working condition and free from defects.
4.2 Sterilization Methods
4.2.1 Steam Sterilization (Autoclaving):
4.2.1.1 Load equipment into the autoclave according to the manufacturer’s instructions.
4.2.1.2 Set the autoclave to the appropriate cycle parameters (temperature, pressure, and time) based on the equipment type and load.
4.2.1.3 Run the sterilization cycle and monitor the process parameters.
4.2.1.4 Allow the equipment to cool before unloading.
4.2.2 Dry Heat Sterilization:
4.2.2.1 Place equipment in the dry heat oven.
4.2.2.2 Set the oven to the appropriate temperature and time parameters.
4.2.2.3 Run the sterilization cycle and monitor the process parameters.
4.2.2.4 Allow the equipment to cool before unloading.
4.2.3 Chemical Sterilization:
4.2.3.1 Immerse equipment in the approved chemical sterilant solution for the specified time.
4.2.3.2 Rinse equipment with sterile water to remove any residual sterilant.
4.2.3.3 Dry the equipment using sterile techniques.
4.3 Quality Control Testing
4.3.1 Perform biological indicator tests to verify the effectiveness of sterilization cycles.
4.3.2 Record test results and compare them with established acceptance criteria.
4.3.3 If sterilization is found to be ineffective, repeat the process and investigate the cause of failure.
4.4 Documentation
4.4.1 Maintain records of sterilization cycles, including equipment loaded, cycle parameters, and test results.
4.4.2 Ensure all records are signed and dated by the responsible personnel.

5) Abbreviations, if any

– QC: Quality Control
– QA: Quality Assurance

6) Documents, if any

– Sterilization Logs
– Quality Control Test Records

7) Reference, if any

– Good Manufacturing Practices (GMP) Guidelines
– International Organization for Standardization (ISO) Standards
– Autoclave and Dry Heat Oven Manufacturer’s Manuals

8) SOP Version

Version 1.0