Procedure for Sanitization of Scraper Blades
| Department | Production/Engineering/Quality Assurance (QA) |
|---|---|
| SOP No. | SOP/Ointment/056 |
| 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 establish a standardized method for the sanitization of scraper blades used in ointment manufacturing. Proper sanitization prevents cross-contamination, ensures product integrity, and maintains compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in the cleaning and sanitization of scraper blades used in mixing and blending equipment in the ointment production process.
3. Responsibilities
- Production Supervisor: Ensures sanitization procedures are followed as per SOP.
- Machine Operator: Disassembles scraper blades and prepares them for cleaning.
- Cleaning Personnel: Conducts thorough cleaning and sanitization of scraper blades.
- Quality Assurance (QA) Personnel: Inspects and verifies sanitization effectiveness.
- Engineering Technician: Assists with scraper blade reassembly if required.
4. Accountability
The Production, Engineering, and QA Managers are accountable for ensuring that scraper blade sanitization follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Sanitization Preparations
- Ensure the mixing equipment is switched off and safely disconnected from power sources.
- Depressurize and cool the system before handling scraper blades.
- Wear appropriate Personal Protective Equipment (PPE), including gloves, goggles, and aprons.
- Ensure that all necessary cleaning and sanitization
agents are available.
5.2 Disassembling Scraper Blades
- Follow the equipment manufacturer’s instructions for safe disassembly.
- Remove scraper blades carefully, avoiding damage to edges or mounting brackets.
- Place the disassembled blades on a clean, designated surface.
5.3 Cleaning Process
5.3.1 Initial Rinsing
- Flush scraper blades with warm purified water to remove loose residues.
- Drain completely before proceeding to detergent cleaning.
5.3.2 Detergent Cleaning
- Prepare a cleaning solution using an approved detergent.
- Scrub blades with soft brushes or non-abrasive pads to remove residual product.
- Ensure all surfaces, including mounting holes and edges, are thoroughly cleaned.
- Rinse blades with purified water to remove detergent residues.
5.4 Sanitization Process
5.4.1 Chemical Sanitization
- Prepare a sanitizing solution (e.g., 70% ethanol or peracetic acid solution).
- Immerse scraper blades in the solution for a minimum of 15 minutes.
- Ensure complete coverage of all blade surfaces.
- Remove blades and allow excess sanitizer to drain.
5.4.2 Heat Sterilization (If Applicable)
- Place scraper blades in an autoclave or dry heat sterilizer.
- Set autoclave to 121°C at 15 psi for 20 minutes or dry heat sterilizer to 160°C for 2 hours.
- Allow cooling before handling sterilized blades.
5.5 Drying and Storage
- Allow scraper blades to air dry in a controlled environment.
- Store sanitized blades in a clean, covered container or designated storage rack.
- Ensure the storage area is free from dust and contaminants.
5.6 Post-Sanitization Inspection
- Conduct a visual inspection to ensure no residues remain.
- Perform swab tests for microbial verification.
- Record the results in the Sanitization Log.
5.7 Documentation and Approval
- Log all sanitization activities in the Sanitization Record.
- QA personnel must review and approve the scraper blades before reuse.
- Retain sanitization records for audits and compliance verification.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
7. Documents
- Sanitization Log (Annexure-1)
- Sanitization 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: Sanitization Log
| Date | Scraper Blade ID | Sanitization Method | Sanitization Agent | Verified By |
|---|---|---|---|---|
| 01/02/2025 | SB-101 | Chemical | 70% Ethanol | QA Officer |
| 02/02/2025 | SB-102 | Heat | Autoclave 121°C/20 min | QA Officer |
Annexure-2: Sanitization Validation Report
| Date | Scraper Blade ID | Sanitization Method | Validation Outcome | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | SB-101 | Chemical | Pass | Approved | QA Head |
| 02/02/2025 | SB-102 | 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 |