Standard Operating Procedure for Cleaning Low Volume Transfer Hoses in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/178/2025
Supersedes	SOP/ELX/178/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To outline the procedure for effective and validated cleaning of low volume transfer hoses used in the manufacturing of elixirs to ensure removal of product residues, cleaning agents, and potential contaminants before reuse.

2. Scope

This SOP applies to all flexible low volume hoses (≤2-inch diameter) used for transferring elixir components, intermediate or final bulk solutions in the Elixir Department.

3. Responsibilities

• Production Operator:
  • Perform cleaning activities as per this SOP.
  • Ensure hoses are labeled and stored after cleaning.
• QA Officer:
  • Verify cleanliness through visual checks and periodic swab/rinse sampling.
• Engineering Department:
  • Ensure availability and maintenance of hose cleaning adapters, fittings, and drying units.

4. Accountability

The Production Head is accountable for cleaning and labeling of hoses. The QA Head is responsible for verification and compliance. The Engineering Head ensures supporting utility infrastructure.

5. Procedure

5.1 Preparation

1. Ensure hose is disconnected from both ends.
2. Verify that the hose is not damaged, cracked, or discolored. If found unsuitable, send for disposal or replacement.
3. Attach hose adapters to facilitate cleaning flow from one end to another.

5.2 Cleaning Steps

1. Initial Rinse: Flush the hose internally with purified water for at least 3 minutes to remove bulk residues.
2. Detergent Wash: Circulate 1% non-ionic or approved cleaning agent solution through the hose using a circulation pump for 5–10 minutes depending on product type and batch size.
3. Intermediate Rinse: Rinse the hose thoroughly with purified water until no foam is observed and conductivity is within PW limits.
4. Final Rinse: Perform a final rinse with hot purified water (60–80°C) for 3 minutes to remove traces of detergent and enhance drying.

5.3 Drying and Storage

1. Connect both ends of the hose to a HEPA-filtered compressed air source to remove internal moisture.
2. Alternatively, hang the hose in a dedicated drying cabinet and allow to air dry.
3. Once dry, cap both ends with sanitized caps and label as “CLEANED – READY FOR USE.”
4. Store the hose in a designated clean area with proper segregation between used and cleaned hoses.

5.4 Cleaning Frequency

1. Clean hoses:
   • Immediately after each batch use
   • Before use if stored beyond validated hold time

5.5 Documentation

1. Record all cleaning details in the Hose Cleaning Logbook (Annexure-1).
2. Include hose ID, cleaning steps performed, cleaned by, verified by, and date of next due cleaning if applicable.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PW: Purified Water
• HEPA: High-Efficiency Particulate Air

7. Documents

1. Hose Cleaning Logbook (Annexure-1)
2. Cleaning Agent Certificate of Analysis
3. Swab/Rinse Sampling Report (if applicable)

8. References

• 21 CFR Part 211.67 – Equipment Cleaning and Maintenance
• WHO TRS 986 – Annex 4: GMP for Pharmaceutical Products
• ICH Q7 – GMP Guidelines for APIs

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Hose Cleaning Logbook

Date	Hose ID	Cleaning Type	Detergent Used	Cleaned By	Verified By	Remarks
11/04/2025	HOSE-LV-05	Batch Use	Neutraclean 1%	Rajesh Kumar	Sunita Reddy	Dry and Labeled

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial SOP Release	New SOP	QA Head
11/04/2025	2.0	Added drying procedure and storage labeling	GMP Compliance	QA Head