Procedure for Cleaning Utensils Used in Ointment Manufacturing
| Department | Production/Quality Assurance (QA)/Engineering |
|---|---|
| SOP No. | SOP/Ointment/059 |
| 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 cleaning utensils used in ointment manufacturing. Proper cleaning ensures removal of residues, prevents cross-contamination, and maintains compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all personnel involved in cleaning and maintaining utensils such as spatulas, mixing spoons, scrapers, beakers, and other tools used in ointment production.
3. Responsibilities
- Production Supervisor: Ensures that cleaning is performed as per this SOP.
- Machine Operator: Collects utensils and prepares them for cleaning.
- Cleaning Personnel: Performs cleaning, sanitization, and drying of utensils.
- Quality Assurance (QA) Personnel: Inspects and verifies cleaning effectiveness.
4. Accountability
The Production and QA Managers are accountable for ensuring that utensil cleaning follows GMP standards and is properly documented.
5. Procedure
5.1 Pre-Cleaning Preparations
- Ensure that all utensils used in the batch are collected for cleaning.
- Wear appropriate Personal Protective Equipment (PPE), including gloves, masks, and aprons.
- Ensure that all cleaning materials, including detergents and sanitizers, are available.
- Inspect utensils for visible residues before starting the cleaning process.
5.2 Cleaning Process
5.2.1 Initial Rinsing
- Rinse utensils
thoroughly with warm purified water to remove loose residues.
For heavily coated utensils, soak in warm water for 10-15 minutes.
5.2.2 Detergent Cleaning
- Prepare a cleaning solution using an approved detergent.
- Use soft brushes or sponges to scrub utensils, ensuring all surfaces are cleaned.
- Ensure cleaning reaches all crevices and edges of utensils.
- Rinse with purified water to remove detergent residues.
5.2.3 High-Pressure Rinsing
- Use high-pressure purified water to rinse off any remaining detergent traces.
- Repeat the rinsing process until all detergent residues are eliminated.
5.2.4 Final Sanitization
- Prepare a sanitizing solution (e.g., 70% ethanol or peracetic acid solution).
- Immerse utensils in the sanitizing solution for at least 10 minutes.
- Ensure complete coverage of all surfaces.
- Remove utensils and drain excess sanitizer.
5.3 Drying and Storage
- Allow utensils to air dry in a controlled environment.
- Store cleaned utensils in a designated clean storage area.
- Ensure utensils are covered to prevent dust accumulation.
5.4 Post-Cleaning Inspection
- Conduct a visual inspection to ensure no residues remain.
- Perform swab tests for microbial verification.
- Record the results in the Cleaning Log.
5.5 Documentation and Approval
- Log all cleaning activities in the Cleaning Record.
- QA personnel must review and approve the cleaned utensils before reuse.
- Retain cleaning records for audits and compliance verification.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- QC – Quality Control
- PPE – Personal Protective Equipment
7. Documents
- Cleaning Log (Annexure-1)
- Cleaning Validation Report (Annexure-2)
8. References
- WHO GMP Guidelines for Pharmaceutical Manufacturing
- 21 CFR Part 211 – Current Good Manufacturing Practices
- ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Cleaning Log
| Date | Utensil Type | Cleaning Solution Used | Sanitization Agent | Verified By |
|---|---|---|---|---|
| 01/02/2025 | Spatula | Detergent Solution | 70% Ethanol | QA Officer |
| 02/02/2025 | Mixing Spoon | Alkaline Cleaner | Peracetic Acid | QA Officer |
Annexure-2: Cleaning Validation Report
| Date | Utensil Type | Swab Test Result | Microbial Limits | Final Status | Approved By |
|---|---|---|---|---|---|
| 01/02/2025 | Spatula | Pass | Within Limit | Approved | QA Head |
| 02/02/2025 | Mixing Spoon | Pass | Within Limit | 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 |