Standard Operating Procedure for Cleaning Procedure for Storage Containers in API Manufacturing

Department	API Manufacturing
SOP No.	SOP/API/013/2025
Supersedes	SOP/API/013/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To lay down the procedure for effective cleaning, drying, labeling, and maintenance of containers used for storage and transfer of raw materials in API manufacturing, to prevent cross-contamination and ensure material integrity.

2. Scope

This SOP is applicable to all stainless steel and HDPE containers used for raw material storage and internal transfers within the warehouse and production areas of the API facility.

3. Responsibilities

• Warehouse Personnel: Perform cleaning, drying, and visual inspection of containers.
• QA Officer: Verify cleanliness before reuse and maintain cleaning records.
• Maintenance Team: Support in deep cleaning or repair of damaged containers.

4. Accountability

The Warehouse Manager is accountable for ensuring containers are cleaned as per schedule, logs are updated, and containers are not reused unless verified clean.

5. Procedure

5.1 Identification and Cleaning Frequency

1. Each container must carry a unique ID and cleaning status tag.
2. Clean containers:
   • Before first use
   • After every use
   • Before reuse if stored empty for more than 72 hours

5.2 Pre-Cleaning Inspection

1. Ensure the container is empty, with no residual material or label remnants.
2. Check for physical damage, rusting, pitting, or chemical stains.
3. If damage is observed, report to the maintenance team for repair.

5.3 Cleaning Procedure

1. Transfer the container to the designated cleaning area.
2. Perform cleaning as per material class:
   • Stainless Steel:
     1. Rinse with potable water to remove residues
     2. Scrub with 2% non-perfumed detergent solution
     3. Rinse twice with purified water
     4. Drain and air dry in controlled environment
   • HDPE Containers:
     1. Wipe outer surface with lint-free cloth
     2. Clean inner surface with mild detergent and rinse
     3. Dry under LAF or clean room air
3. For containers used with hazardous materials, follow cleaning with appropriate neutralizing agents and PPE.

5.4 Labeling and Storage

1. After drying, attach “CLEANED” label with:
   • Container ID
   • Date of cleaning
   • Cleaned by
   • Verified by (QA)
2. Store cleaned containers in closed racks or shelves in the “Clean Container Area.”

5.5 Documentation and Records

1. Update the “Container Cleaning Log” (Annexure-1) after every cleaning cycle.
2. QA to review and sign off daily cleaning logs.
3. Any deviation must be documented and investigated.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• HDPE: High-Density Polyethylene
• LAF: Laminar Air Flow

7. Documents

1. Container Cleaning Log (Annexure-1)
2. Cleaning Checklist (Annexure-2)
3. Deviation Form (Annexure-3)

8. References

• ICH Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• WHO TRS 986 Annex 2 – Warehouse and Equipment Sanitation
• 21 CFR Part 211.67 – Equipment Cleaning and Maintenance

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Container Cleaning Log

Date	Container ID	Type	Cleaned By	Verified By	Status
13/04/2025	SS-101	Stainless Steel			Cleaned

Annexure-2: Cleaning Checklist

Step	Action	Performed By	Remarks
1	Rinse with potable water
2	Scrub with detergent
3	Final rinse with purified water
4	Dry under LAF

Annexure-3: Deviation Form

Date	Container ID	Nature of Deviation	Immediate Action Taken	QA Review
13/04/2025	HDPE-203	Residual stains observed	Re-cleaned	Accepted

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2022	1.0	Initial Release	Process Establishment	QA Head
13/04/2025	2.0	Added Deviation and Checklist	Audit Recommendation	QA Head