Standard Operating Procedure for Preventive Maintenance of Filling Machines in Elixir Manufacturing

Department	Elixir Department
SOP No.	SOP/ELX/147/2025
Supersedes	SOP/ELX/147/2022
Page No.	Page 1 of 10
Issue Date	11/04/2025
Effective Date	15/04/2025
Review Date	11/04/2026

1. Purpose

To define the procedure for preventive maintenance (PM) of filling machines used in elixir manufacturing, ensuring consistent performance, minimizing downtime, and preventing batch contamination due to mechanical failure.

2. Scope

This SOP applies to all automatic, semi-automatic, and volumetric filling machines used for filling elixirs into containers in the Elixir Department.

3. Responsibilities

• Engineering Department:
  • Perform preventive maintenance activities as per the schedule.
  • Record all PM activities and calibrations in the Equipment Maintenance Log.
• Production Operator:
  • Report any unusual machine behavior during operation.
  • Ensure the machine is ready for maintenance (clean, shutdown, de-energized).
• QA Officer:
  • Review PM records and verify completion before machine release for use.

4. Accountability

The Engineering Head is accountable for timely and compliant maintenance of filling machines. The Production Head is responsible for machine readiness and coordination.

5. Procedure

5.1 Preparation for Maintenance

1. Verify that the filling machine is cleaned and labeled as “UNDER MAINTENANCE.”
2. Switch off the main power supply and display “DO NOT OPERATE” tag.
3. Ensure all compressed air, WFI, and vacuum lines are disconnected (if applicable).

5.2 Preventive Maintenance Checklist

1. Inspect and clean nozzles, filling heads, and valve seats.
2. Check alignment and integrity of pistons or dosing cylinders.
3. Lubricate mechanical moving parts like cams, levers, and chains.
4. Check electrical and PLC panels for dust accumulation and loose connections.
5. Tighten all sensors and proximity switches.
6. Inspect pneumatic lines and actuators for leaks or damage.
7. Verify load cell calibration (if applicable).

5.3 Calibration and Test Run

1. Perform volume calibration using certified volumetric flasks or standard weights.
2. Run a dummy cycle with purified water and observe filling accuracy and speed.
3. Record all calibration values and corrections made in the Calibration Log (Annexure-1).

5.4 Documentation and Handover

1. Complete the Preventive Maintenance Checklist and record observations in the Maintenance Log (Annexure-2).
2. QA to review PM records and authorize machine usage.
3. Label the machine as “READY FOR USE” after QA clearance.

5.5 Maintenance Frequency

1. Monthly: Basic mechanical inspection and lubrication.
2. Quarterly: Detailed inspection with calibration verification.
3. Annually: Complete overhaul and replacement of worn parts.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• PM: Preventive Maintenance
• WFI: Water for Injection
• PLC: Programmable Logic Controller

7. Documents

1. Calibration Log (Annexure-1)
2. Preventive Maintenance Log (Annexure-2)
3. QA Clearance Form

8. References

• 21 CFR Part 211 – Equipment Maintenance
• WHO TRS 986 – Maintenance and Calibration Guidelines
• ICH Q9 – Quality Risk Management

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Calibration Log

Date	Machine ID	Volume Set	Volume Delivered	Deviation	Status	Engineer
11/04/2025	FM-ELX-02	100 ml	99.8 ml	-0.2 ml	Pass	Ramesh Patel

Annexure-2: Preventive Maintenance Log

Date	Machine ID	Activity Performed	Parts Lubricated	Replaced Components	Remarks	Engineer
11/04/2025	FM-ELX-02	Quarterly PM	Chain, Piston Rods	O-ring	Performance OK	Ramesh Patel

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	Updated calibration and safety instructions	Compliance Update	QA Head