Procedure for Sterilizing Machine Parts
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/054 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define a standardized method for sterilizing machine parts used in ointment manufacturing. Proper sterilization ensures elimination of microbial contamination, maintains product integrity, and complies with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel responsible for the sterilization of machine parts, including those from mixers, homogenizers, filling machines, and other manufacturing equipment used in ointment production.
3. Responsibilities
- Production Supervisor: Ensures all machine parts undergo proper sterilization as per this SOP.
- Machine Operator: Disassembles and prepares machine parts for sterilization.
- Cleaning and Sterilization Personnel: Conducts sterilization processes and maintains records.
- Quality Assurance (QA) Personnel: Verifies sterilization effectiveness and ensures compliance.
4. Accountability
The Production and QA Managers are accountable for ensuring that machine part sterilization follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Sterilization Preparations
- Ensure all machine parts are thoroughly cleaned before sterilization (refer to relevant cleaning SOPs).
- Wear appropriate Personal Protective Equipment (PPE), including gloves, masks, and aprons.
- Ensure that sterilization equipment is calibrated and functioning correctly.
- Verify that the selected sterilization method is suitable for the machine parts.
5.2
Selection of Sterilization Method
- The appropriate sterilization method is selected based on machine part material:
- Autoclaving: For heat-resistant stainless steel parts.
- Dry Heat Sterilization: For metal parts that cannot be exposed to moisture.
- Chemical Sterilization: For heat-sensitive parts (e.g., using peracetic acid or hydrogen peroxide vapor).
- UV Sterilization: For plastic and non-metallic machine parts.
5.3 Sterilization Procedures
5.3.1 Autoclaving Process
- Place machine parts in an autoclavable tray.
- Load the autoclave chamber, ensuring parts are evenly spaced for steam penetration.
- Set the autoclave to 121°C at 15 psi pressure for 20 minutes.
- Allow the cycle to complete and ensure a slow pressure release.
- Remove and inspect parts for complete sterilization.
5.3.2 Dry Heat Sterilization Process
- Place machine parts in a sterilization oven.
- Set the temperature to 160°C–180°C for at least 2 hours.
- Ensure uniform heat distribution and monitor temperature throughout the cycle.
- Allow parts to cool before handling.
5.3.3 Chemical Sterilization Process
- Prepare a sterilization solution (e.g., 2% peracetic acid solution or 6% hydrogen peroxide).
- Immerse machine parts completely in the solution for 30 minutes.
- Rinse thoroughly with sterile purified water to remove chemical residues.
5.3.4 UV Sterilization Process
- Place plastic or sensitive machine parts in a UV sterilization chamber.
- Expose the parts to UV light for 15-30 minutes.
- Avoid direct exposure to UV radiation during handling.
5.4 Post-Sterilization Handling
- Transfer sterilized machine parts to a clean, dry, and dust-free storage area.
- Ensure all sterilized parts are covered or stored in sterile bags until use.
- Record sterilization parameters and outcomes in the Sterilization Log.
5.5 Documentation and Approval
- Log all sterilization activities in the Sterilization Record.
- QA must approve sterilized machine parts before use.
- Retain sterilization records for audits and compliance verification.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
7. Documents
- Sterilization Log (Annexure-1)
- Sterilization Validation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ISO 17665: Sterilization of Healthcare Products
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Sterilization Log
| Date | Machine Part ID | Sterilization Method | Temperature/Time | Verified By |
|---|---|---|---|---|
| 01/02/2025 | SP-101 | Autoclaving | 121°C/20 min | QA Officer |
| 02/02/2025 | SP-102 | Dry Heat | 160°C/2 hrs | QA Officer |
Annexure-2: Sterilization Validation Report
| Date | Machine Part ID | Sterilization Method | Validation Outcome | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | SP-101 | Autoclaving | Pass | Approved | QA Head |
| 02/02/2025 | SP-102 | Dry Heat | Pass | Approved | QA Head |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |