Standard Operating Procedure for Preparation and Usage of Disinfectant Solutions in Gel Manufacturing
| Department | Gel Manufacturing |
|---|---|
| SOP No. | SOP/GM/144/2025 |
| Supersedes | SOP/GM/144/2022 |
| Page No. | Page 1 of 10 |
| Issue Date | 09/06/2025 |
| Effective Date | 11/06/2025 |
| Review Date | 09/06/2027 |
1. Purpose
To establish a standardized procedure for the preparation, labeling, rotation, and usage of disinfectant solutions used in the gel manufacturing area to maintain microbial control and ensure compliance with GMP guidelines.
2. Scope
This SOP applies to all personnel involved in preparing and using disinfectant solutions in the gel manufacturing area, including support and ancillary cleanroom zones.
3. Responsibilities
- Housekeeping Personnel: Responsible for preparation and labeling of disinfectants as per instructions.
- Production Chemist: Verifies preparation process and approves use.
- QA Department: Reviews records,
maintains disinfectant rotation logs, and ensures compliance.
4. Accountability
The Head – Manufacturing is accountable for the effective implementation of disinfectant preparation and usage in compliance with internal SOPs and regulatory standards.
5. Procedure
5.1 Preparation of Disinfectant Solutions
- Disinfectants to be prepared in a controlled environment using dedicated equipment.
- Use only approved disinfectants from the qualified vendor list.
- Verify the expiry date and concentration before dilution.
- Weigh and dilute the disinfectant in purified water using calibrated measuring containers.
- Label all prepared solutions with the following details:
- Name of Disinfectant
- Concentration
- Preparation Date
- Use Before Date
- Prepared By and Checked By
5.2 Storage and Stability
- Store disinfectants in closed containers at designated storage areas.
- Do not use expired or discolored solutions.
- Label containers clearly with “Prepared Disinfectant – For External Use Only.”
5.3 Disinfectant Rotation
- Use at least two different types of disinfectants in rotation.
- Rotate monthly to prevent microbial resistance.
- Record rotation in the Disinfectant Rotation Log (Annexure-2).
5.4 Usage Procedure
- Apply disinfectants using sterile lint-free wipes or mops.
- Allow appropriate contact time (minimum 5 minutes unless otherwise validated).
- Avoid reuse of leftover solutions from previous days.
5.5 Documentation and Control
- Maintain preparation log, usage log, and rotation log.
- QA should verify these logs during routine audits.
- In case of deviation (e.g., improper dilution), inform QA and discard the solution.
6. Abbreviations
- QA: Quality Assurance
- GMP: Good Manufacturing Practices
- SOP: Standard Operating Procedure
- IPA: Isopropyl Alcohol
7. Documents
- Disinfectant Preparation Log – Annexure-1
- Disinfectant Rotation Log – Annexure-2
- Disinfectant Usage Log – Annexure-3
8. References
- EU GMP Guidelines – Annex 1
- WHO Guidelines on Cleaning and Disinfection in Manufacturing
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: Disinfectant Preparation Log
| Date | Disinfectant Name | Concentration | Prepared By | Checked By | Use Before |
|---|---|---|---|---|---|
Annexure-2: Disinfectant Rotation Log
| Month | Primary Disinfectant | Secondary Disinfectant | Rotation Approved By |
|---|---|---|---|
Annexure-3: Disinfectant Usage Log
| Date | Area | Disinfectant | Used By | Verified By |
|---|---|---|---|---|
Revision History
| Revision Date | Revision No. | Change Description | Reason | Approved By |
|---|---|---|---|---|
| 20/06/2022 | 1.0 | Initial Issue | New SOP | QA Head |
| 09/06/2025 | 2.0 | Added section on disinfectant contact time and discard policy | Regulatory update | QA Head |