Standard Operating Procedure for Cleaning Labeling Equipment in Gel Packaging Operations
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/056/2025 |
| Supersedes | SOP/GM/056/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 02/06/2025 |
| Effective Date | 04/06/2025 |
| Review Date | 02/06/2026 |
1. Purpose
To define the procedure for cleaning labeling equipment used in the packaging of gel formulations to ensure equipment hygiene, minimize cross-contamination, and maintain compliance with Good Manufacturing Practices (GMP).
2. Scope
This SOP applies to all labeling machines used in the primary and secondary packaging lines for
gel-based pharmaceutical products at the Gel Manufacturing department.
3. Responsibilities
- Production Operator: Responsible for cleaning the labeling machine as per this SOP.
- Packaging Supervisor: Responsible for verifying and documenting the cleaning process.
- QA Officer: Responsible for reviewing the records and ensuring GMP compliance.
4. Accountability
Department Head and QA Head are accountable for implementation and compliance with this SOP.
5. Procedure
5.1 Pre-Cleaning Preparation
- Ensure the labeling machine is turned off and isolated from the power source.
- Place a “To Be Cleaned” status label on the equipment.
- Wear appropriate PPE including gloves, mask, and protective eyewear.
5.2 Dismantling and Access
- Remove label rolls, sensor arms, label applicators, and rubber rollers as per equipment design.
- Place dismantled parts in a designated SS tray labeled “To Be Cleaned”.
5.3 Cleaning Removable Parts
- Rinse with potable water to remove any loose particles or adhesive residue.
- Wash with 2% non-ionic detergent solution using a soft nylon brush.
- Rinse thoroughly with purified water and allow to dry using filtered compressed air.
5.4 Cleaning Machine Body
- Clean external surfaces using 70% IPA solution and lint-free cloth.
- Ensure adhesive sensors, label tracks, and feed paths are free from glue and paper particles.
5.5 Post-Cleaning Steps
- Visually inspect all cleaned parts and surfaces.
- Reassemble the equipment once confirmed clean and dry.
- Affix “Cleaned” status label with operator initials and date.
5.6 Documentation
- Record all cleaning activities in the Equipment Cleaning Log (Annexure-1).
- Fill the Labeling Machine Cleaning Checklist (Annexure-2).
- Supervisor to verify and QA to review during routine audits.
5.7 Cleaning Frequency
- After every batch or product change.
- After equipment maintenance.
- Once every 72 hours if equipment is idle.
6. Abbreviations
- IPA: Isopropyl Alcohol
- SS: Stainless Steel
- PPE: Personal Protective Equipment
- QA: Quality Assurance
7. Documents
- Labeling Machine Cleaning Log – Annexure-1
- Labeling Machine Cleaning Checklist – Annexure-2
8. References
- Manufacturer’s Equipment Cleaning Manual
- GMP Guidelines – WHO TRS 986
- Cleaning Validation Protocol
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | Jr. Production Chemist | QA Executive | Head – Manufacturing |
| Department | Gel Manufacturing | Quality Assurance | Manufacturing |
11. Annexures
Annexure-1: Labeling Machine Cleaning Log
| Date | Machine ID | Product Name | Batch No. | Cleaned By | Verified By | Remarks |
|---|---|---|---|---|---|---|
Annexure-2: Labeling Machine Cleaning Checklist
| Cleaning Step | Status (Yes/No) | Comments | Verified By |
|---|---|---|---|
| Removal of Label Rolls | |||
| Detergent Wash of Removables | |||
| Wipe Down with IPA | |||
| Visual Inspection | |||
| Reassembly & Labeling |
Revision History
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 01/06/2022 | 1.0 | Initial Release | New equipment SOP | QA Head |
| 02/06/2025 | 2.0 | Checklist and Template Enhanced | GMP Compliance | QA Head |