Scope

This procedure applies to all packing machines located in the secondary packaging areas within the sterile injectable manufacturing facility.

3. Responsibilities

• Maintenance Technician: Perform preventive maintenance activities as per schedule.
• Machine Operator: Execute cleaning steps and report performance abnormalities.
• QA Executive: Verify cleaning effectiveness and document approval.
• Engineering Supervisor: Ensure timely completion of maintenance and proper documentation.

4. Accountability

The Head of Engineering is accountable for implementing and verifying adherence to this SOP for packing machine maintenance and cleaning.

5. Procedure

5.1 Preparation Before Maintenance and Cleaning

1. Ensure that the machine is switched off and disconnected from the main power supply.
2. Place “Under Maintenance” or “Do Not Operate” signage on the machine.
3. Ensure proper PPE is worn, including gloves, apron, and safety goggles.
4. Remove all product contact parts such as belt, rollers, and blades for separate cleaning.

5.2 Routine Cleaning Procedure

1. Use a clean, lint-free cloth moistened with 70% IPA to wipe machine surfaces.
2. Clean rollers, conveyor belts, sensors, and external surfaces of the sealing unit.
3. Use nylon brushes to clean hard-to-reach areas and corners.
4. Dry all cleaned surfaces with sterile lint-free cloths to prevent moisture retention.
5. Ensure no lubricant, dust, label residues, or glue remains on the machine.
6. Record completion of cleaning in the Packing Machine Cleaning Log (Annexure-1).

5.3 Preventive Maintenance Procedure

1. Conduct weekly, monthly, and quarterly checks as per the preventive maintenance schedule.
2. Inspect and tighten loose bolts, nuts, and fixtures.
3. Check alignment of rollers, cutters, and sensors; adjust as necessary.
4. Replace worn-out or damaged parts using approved spares.
5. Lubricate moving mechanical parts using food-grade lubricants where required.
6. Check calibration status of weighing units and label applicators.
7. Fill Maintenance Checklist (Annexure-2) post every activity.

5.4 Post-Maintenance and Cleaning Verification

1. QA must verify the cleanliness and functionality of the machine post-maintenance.
2. Sign-off in the Equipment Clearance Form (Annexure-3) before releasing the machine for production.
3. Ensure the machine is free from any leftover tools, residues, or cleaning materials.
4. Affix “Cleaned and Ready for Use” tag to the machine.

5.5 Handling Deviations

1. If any abnormalities are detected during maintenance:
   • Report immediately to Engineering Supervisor.
   • Document deviation in the Maintenance Deviation Log.
   • Investigate root cause and apply corrective actions.

6. Abbreviations

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

7. Documents

1. Packing Machine Cleaning Log – Annexure-1
2. Preventive Maintenance Checklist – Annexure-2
3. Equipment Clearance Form – Annexure-3

8. References

• EU GMP Annex 15 – Qualification and Validation
• WHO TRS 986 – Guidelines on Cleaning Validation
• Internal Machine Manuals for Model XY-Series

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: Packing Machine Cleaning Log

Date	Machine ID	Operator	Cleaning Status	Verified By (QA)
23/06/2025	PM-101	Rakesh Mehta	Clean	Sunita Reddy

Annexure-2: Preventive Maintenance Checklist

Maintenance Date	Machine ID	Activity Performed	Status	Technician
22/06/2025	PM-101	Belt Alignment & Lubrication	Completed	Arvind Yadav

Annexure-3: Equipment Clearance Form

Machine ID	Cleaned	Maintained	QA Approval	Date
PM-101	Yes	Yes	Sunita Reddy	23/06/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/03/2022	1.0	Initial Issue	New SOP	QA Head
24/06/2025	2.0	Annexures and maintenance checks updated	Annual Review	QA Head