Gel Manufacturing: SOP for Use of Color Coding in Gel Manufacturing Areas – V 2.0
Standard Operating Procedure for Use of Color Coding in Gel Manufacturing Areas
| Department |
Gel Manufacturing |
| SOP No. |
SOP/GM/127/2025 |
| Supersedes |
SOP/GM/127/2022 |
| Page No. |
Page 1 of 9 |
| Issue Date |
09/06/2025 |
| Effective Date |
11/06/2025 |
| Review Date |
09/06/2027 |
1. Purpose
To describe the procedure for implementing and maintaining a standardized color coding system in the gel manufacturing area to enhance operational efficiency, ensure material identification, and avoid cross-contamination.
2. Scope
This SOP applies to all equipment, pipelines, containers, garments,
labels, and zones within the gel manufacturing department where color coding is employed.
3. Responsibilities
- Production Personnel: Adhere to color coding guidelines during manufacturing operations.
- Engineering Team: Ensure correct painting and labeling of pipelines and equipment as per color code.
- Quality Assurance: Verify compliance with the color coding policy during area and equipment audits.
4. Accountability
Department Head – Gel Manufacturing
5. Procedure
5.1 Color Coding Guidelines
The following standardized color coding shall be used:
| Item |
Color Code |
Purpose |
| Purified Water Lines |
Sky Blue |
Indicates water pipeline |
| Compressed Air Lines |
Yellow |
Compressed air pipeline |
| Steam Lines |
Red |
Live steam pipeline |
| Vacuum Lines |
Grey |
Vacuum pipeline |
| Product Contact Equipment |
Green |
Indicates clean contact surfaces |
| Non-product Contact Equipment |
White |
Indicates general utilities |
| Reject Materials |
Black |
Identification of rejected items |
| Clean Garments |
Blue |
Indicates cleanroom attire |
| Used Garments |
Brown |
Garments awaiting laundering |
| Labels for Raw Materials |
Pink |
Easy identification of RM |
| Labels for Intermediates |
Yellow |
In-process material ID |
| Labels for Finished Product |
White |
Release status and traceability |
5.2 Implementation
- Ensure painting or tagging of all items using durable, non-toxic, and heat-resistant color coatings.
- Display a laminated color code chart at entry points and key manufacturing areas.
- Ensure personnel are trained on the correct interpretation and usage of the color coding scheme.
5.3 Maintenance and Audit
- Engineering team to inspect and refresh color markings every 6 months.
- QA to verify compliance with SOP during routine audits and deviation investigations.
5.4 Deviations
- Any observed deviation from color coding must be immediately reported to QA.
- Record deviation in the Non-Conformance Register and take corrective actions.
6. Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- RM: Raw Material
7. Documents
- Color Coding Display Chart – Annexure-1
- Line and Equipment Color Coding Checklist – Annexure-2
8. References
- IS 2379: Color code for identification of pipelines
- WHO GMP Guidelines
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: Color Coding Display Chart
| Area |
Item |
Color Code |
| Manufacturing Area |
Water Lines |
Sky Blue |
| Utilities |
Steam |
Red |
| Personnel |
Clean Garments |
Blue |
Annexure-2: Color Coding Checklist
| Item |
Color as per SOP |
Observed Color |
Status |
Remarks |
| Purified Water Pipeline |
Sky Blue |
|
|
|
| Clean Garment Bin |
Blue |
|
|
|
| Label for Finished Product |
White |
|
|
|
Revision History
| Revision Date |
Revision No. |
Change Description |
Reason |
Approved By |
| 01/03/2022 |
1.0 |
Initial version |
New SOP |
QA Head |
| 09/06/2025 |
2.0 |
Added pipeline and garment codes |
Compliance & Visual Controls |
QA Head |