Standard Operating Procedure for Use of Validated Cleaning Detergents in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/189/2025
Supersedes	SOP/ELX/189/2022
Page No.	Page 1 of 9
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define the procedure for selection, preparation, usage, and control of validated cleaning detergents in the Elixir Manufacturing Department to ensure equipment cleanliness, regulatory compliance, and product quality.

2. Scope

This SOP applies to all validated cleaning detergents used for cleaning product-contact and non-contact equipment, utensils, accessories, and facility surfaces in the Elixir Department.

3. Responsibilities

• Production Operator:
  • Use only approved and validated cleaning agents as per this SOP.
  • Ensure correct dilution and cleaning procedure.
• QA Officer:
  • Ensure detergent validation status and documentation is available.
  • Review detergent logs and change control documents.
• Engineering/Stores:
  • Ensure storage of cleaning agents as per manufacturer’s instructions.

4. Accountability

The Production Head is accountable for detergent usage compliance. The QA Head is accountable for validation, verification, and change control. The Engineering Head ensures safe handling and compatibility.

5. Procedure

5.1 Selection and Validation

1. Only validated cleaning agents (e.g., Neutraclean, Alkaclean, Acidiclean) shall be used.
2. Selection shall be based on:
   • Residue profile of the product
   • Cleaning material compatibility
   • Detergent toxicity, pH, rinsibility
3. Validation must demonstrate effective residue removal, no interference in analysis, and rinse-ability to acceptable levels.

5.2 Storage and Handling

1. Store detergent containers in a cool, dry area with proper labeling and MSDS access.
2. Use containers with batch numbers and expiry dates clearly visible.
3. Do not use expired or physically deteriorated detergent.

5.3 Preparation of Detergent Solution

1. Prepare detergent solution in designated areas only.
2. Use clean containers labeled with:
   • Detergent name
   • Concentration
   • Preparation date and expiry (max 24 hours)
   • Prepared by and verified by
3. Use purified water to prepare detergent solution at validated concentration (e.g., 1% w/v).
4. Stir until fully dissolved. Use only freshly prepared solution.

5.4 Usage in Cleaning

1. Apply detergent using lint-free cloth, scrubber, brush, or circulation (CIP).
2. Contact time should follow the validated protocol (e.g., 10 minutes for heavy residue).
3. Rinse with purified water until no visible foam and pH of rinse water is within acceptable limits (e.g., 6.0–7.5).
4. Ensure no residue of detergent remains on surface after rinsing.

5.5 Documentation and Traceability

1. Enter details of detergent usage in the Detergent Usage Logbook (Annexure-1).
2. Document the detergent name, batch number, date of preparation, equipment cleaned, operator name, and QA review.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• CIP: Clean-In-Place
• MSDS: Material Safety Data Sheet

7. Documents

1. Detergent Usage Logbook (Annexure-1)
2. Detergent Validation Summary Report
3. MSDS for Each Approved Detergent

8. References

• 21 CFR Part 211.67 – Cleaning and Maintenance
• ICH Q7 – GMP for APIs
• WHO TRS 986 Annex 4 – Cleaning Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Detergent Usage Logbook

Date	Detergent Name	Batch No.	Concentration	Prepared By	Used For (Equipment ID)	QA Verified
11/04/2025	Neutraclean	NC-2403	1% w/v	Rajesh Kumar	MXR-ELX-12	Sunita Reddy

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Release	New SOP	QA Head
11/04/2025	2.0	Updated preparation and labeling requirements	Audit Compliance	QA Head