lyophilizers used in the sterile injectable manufacturing area at [Insert Facility Name] immediately following completion of each lyophilized batch.

3. Responsibilities

• Production Operator: Execute the cleaning process as per the defined steps.
• Maintenance Technician: Assist in equipment access or part dismantling as needed.
• QA Officer: Verify cleanliness visually and review cleaning records.
• Validation Officer: Conduct cleaning validation studies as per protocol.

4. Accountability

The Production Manager is accountable for ensuring that the lyophilizer is cleaned and documented according to this SOP before re-use or maintenance.

5. Procedure

5.1 Preparation

1. Ensure that the lyophilizer has completed its cycle and chamber is at ambient temperature.
2. Wear appropriate sterile gowning and PPE as per gowning SOP.
3. Display the “Under Cleaning” status label on the equipment.

5.2 Removal of Bulk Residue

1. Open the lyophilizer door and allow ventilation for 10 minutes.
2. Use sterile lint-free wipes moistened with WFI to remove visible powder residues from the chamber shelves and walls.
3. Use clean plastic scrapers to dislodge any adhered material without damaging surfaces.

5.3 Detergent Wash

1. Prepare a 0.5% solution of approved non-ionic detergent in WFI.
2. Wipe all surfaces inside the chamber with detergent solution using sterile mops or wipes.
3. Pay special attention to corners, shelf edges, door seals, and condenser area.
4. Rinse thoroughly with WFI until no detergent residue is observed (minimum 3 rinses).

5.4 CIP System Activation (if applicable)

1. If the lyophilizer is CIP-compatible, initiate the automated CIP cycle as per the manufacturer’s manual.
2. Record parameters including cycle time, detergent used, and rinse volume in Annexure-1.

5.5 Final Wipe and Drying

1. After rinsing, perform a final wipe down with 70% IPA using sterile wipes.
2. Allow surfaces to dry naturally or use filtered air if required.
3. Inspect visually for absence of residue, water spots, or damage.

5.6 Condenser and Drain Cleaning

1. Flush the condenser drain line with WFI followed by 70% IPA.
2. Ensure drain area is clean and free from blockages.

5.7 Post-Cleaning Verification

1. QA officer to perform visual inspection and approve cleanliness.
2. Record approval in Annexure-2.

5.8 Documentation and Line Clearance

1. Complete all entries in the Cleaning Checklist (Annexure-3).
2. Once verified, change status label to “Cleaned & Ready for Use.”

5.9 Cleaning Frequency

• Routine Cleaning: After every batch.
• Periodic Cleaning: Once weekly or during preventive maintenance.
• Product Changeover: Mandatory full clean and verification.

6. Abbreviations

• SOP: Standard Operating Procedure
• WFI: Water for Injection
• IPA: Isopropyl Alcohol
• QA: Quality Assurance
• CIP: Clean-in-Place

7. Documents

1. CIP Operation Log – Annexure-1
2. Post-Cleaning QA Approval Log – Annexure-2
3. Cleaning Checklist – Annexure-3

8. References

• WHO TRS 961 – GMP for Sterile Pharmaceuticals
• ICH Q9 – Quality Risk Management
• FDA Guidance – Cleaning of Equipment

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: CIP Operation Log

Date	Cycle Time (min)	Detergent Used	Volume of WFI	Operator
18/06/2025	45	Detergent A	40 L	Ravi Yadav

Annexure-2: Post-Cleaning QA Approval Log

Date	Lyophilizer ID	Inspected By	Result	Remarks
18/06/2025	LYO-001	Sunita Reddy	Pass	Visually Clean

Annexure-3: Cleaning Checklist

Step	Status (Yes/No)	Remarks	Operator
Residue Removal	Yes	Powder cleared	Manish Kumar
Detergent Wipe	Yes	Completed	Manish Kumar
Rinse Verification	Yes	No foam	Manish Kumar
Drying	Yes	Air dried	Manish Kumar

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New SOP	QA Head
18/06/2025	2.0	Annexures updated, CIP section added	Annual Review	QA Head