applies to all prefilled syringe filling machines used for aseptic processing of injectable formulations at [Company Name]’s sterile manufacturing facility.

3. Responsibilities

• Production Operator: Performs the cleaning activities as per the approved cleaning SOP.
• Production Supervisor: Supervises cleaning operations and ensures completion of documentation.
• QA Personnel: Verifies cleanliness and signs off the cleaning verification records.
• Engineering: Assists in partial dismantling or component removal if required.

4. Accountability

The Head of Production shall be accountable for ensuring compliance with this SOP and completion of all required cleaning activities for prefilled syringe filling machines.

5. Procedure

5.1 Pre-Cleaning Requirements

1. Ensure the equipment is switched off and all safety interlocks are engaged.
2. Place “UNDER CLEANING” tag at the equipment.
3. Wear appropriate PPE before commencing the cleaning operation.

5.2 Cleaning Steps

1. Remove all product-contact parts such as filling needles, nozzles, and hoppers.
2. Rinse parts with WFI to remove loose residues.
3. Clean each part using a validated cleaning agent solution and lint-free cloth.
4. Use dedicated cleaning brushes for internal surfaces and tubing.
5. Rinse thoroughly with WFI to remove traces of cleaning agent.
6. Wipe external machine surfaces with 70% IPA solution from top to bottom in one direction.
7. Use separate lint-free wipes for each machine surface to prevent cross-contamination.

5.3 Drying and Assembly

1. Allow all cleaned parts to dry in a controlled clean area (Grade B or ISO 5).
2. Reassemble only after QA visual inspection and line clearance.
3. Ensure proper fitment and record assembly checklist.

5.4 Cleaning Frequency

• Batch-to-Batch Cleaning: Performed between products of same composition.
• Product Changeover: Performed when switching products of different composition or strength.
• Periodic Cleaning: Conducted weekly/monthly as part of preventive maintenance.

5.5 Cleaning Verification

1. QA personnel shall perform visual inspection for cleanliness.
2. Swab or rinse sampling to be done as per cleaning validation protocol (see Annexure-2).
3. Results must be within acceptable limits defined in the validation report.

6. Abbreviations

• SOP: Standard Operating Procedure
• PPE: Personal Protective Equipment
• WFI: Water for Injection
• IPA: Isopropyl Alcohol
• QA: Quality Assurance

7. Documents

1. Equipment Cleaning Log – Annexure-1
2. Cleaning Verification Log – Annexure-2
3. Reassembly Checklist – Annexure-3

8. References

• WHO TRS 961 Annex 6: GMP for Sterile Pharmaceutical Products
• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients
• 21 CFR Part 211: Current Good Manufacturing Practices

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation	Manufacturing Executive	QA Executive	Head QA
Department	Production	Quality Assurance	Quality Assurance

11. Annexures

Annexure-1: Equipment Cleaning Log

Date	Machine ID	Cleaned By	Checked By
17/06/2025	SFM-PRF-002	Rajesh Kumar	Sunita Reddy

Annexure-2: Cleaning Verification Log

Date	Sampling Type	Location	Result	Verified By
17/06/2025	Swab	Filling Needle	Pass	Anita Sharma

Annexure-3: Reassembly Checklist

Part	Cleaned	Dry	Assembled	Verified By
Needles	Yes	Yes	Yes	QA Inspector
Nozzles	Yes	Yes	Yes	QA Inspector

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial Issue	New SOP	QA Head
18/06/2025	2.0	Updated format and added validation checkpoints	Annual Review	QA Head