Gel Manufacturing: SOP for Troubleshooting Gel Filling Machines – V 2.0

Standard Operating Procedure for Troubleshooting Gel Filling Machines in Manufacturing

Department	Gel Manufacturing
SOP No.	SOP/GM/176/2025
Supersedes	SOP/GM/176/2022
Page No.	Page 1 of 11
Issue Date	09/06/2025
Effective Date	11/06/2025
Review Date	09/06/2027

1. Purpose

To provide a detailed and systematic approach for troubleshooting operational issues associated with gel filling machines to minimize downtime and ensure uninterrupted, quality-compliant production.

2. Scope

This procedure applies to all gel filling machines used in the Gel Manufacturing Department, including volumetric fillers, piston fillers, and rotary fillers used for various gel formulations.

3. Responsibilities

Machine Operator: Perform first-level troubleshooting and escalate issues when unresolved.
Maintenance Technician: Perform in-depth diagnostics and rectification of mechanical and electrical faults.
Production Supervisor: Document issues and coordinate with QA for resolution tracking.
QA Executive: Verify corrective actions and approve restart of

equipment post-resolution.

4. Accountability

The Head of Manufacturing is accountable for ensuring proper training, implementation, and compliance with this SOP.

5. Procedure

5.1 General Troubleshooting Workflow

Stop the machine immediately if:
- Product leakage is observed.
- Machine fails to dispense accurate quantity.
- Any unusual noise, vibration, or mechanical resistance occurs.
Initiate Lockout/Tagout (LOTO) before any physical inspection or repair.
Inform the Maintenance Department and Production Supervisor.

5.2 Common Issues and Actions

Issue	Cause	Corrective Action
Underfilling or Overfilling	Incorrect calibration or air bubbles in the product line	Check volume settings; remove air from product line
No Fill	Clogged nozzle or valve malfunction	Clean nozzle; check solenoid valve and piston stroke
Spillage/Leakage	Seal wear or incorrect nozzle alignment	Replace gaskets/seals; realign nozzle
Inconsistent Fill Speed	Pressure fluctuations or motor fault	Verify air compressor; inspect motor drives
Machine Stoppage	Sensor misalignment or safety interlock trigger	Check safety sensors and door interlocks

5.3 Maintenance Escalation

If first-line troubleshooting fails, log the issue in the Machine Downtime Register (Annexure-1).
Maintenance Technician to perform diagnostics using checklist (Annexure-2).
Document root cause and corrective action in the Trouble Resolution Form (Annexure-3).

5.4 Post-Troubleshooting Steps

QA to verify corrective action and approve restart.
Conduct a trial run with placebo or approved product.
Resume production after QA clearance.
Ensure cleaning validation post-maintenance if product contact parts are disturbed.

6. Abbreviations

LOTO: Lockout/Tagout
QA: Quality Assurance
SOP: Standard Operating Procedure
RPM: Revolutions per Minute

7. Documents

Machine Downtime Register – Annexure-1
Troubleshooting Checklist – Annexure-2
Trouble Resolution Form – Annexure-3

8. References

Manufacturing Equipment Maintenance Manual
GMP Guidelines for Equipment Maintenance
SOP/GM/136/2025 – Calibration of Manufacturing Equipment

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Machine Downtime Register

Date	Time	Machine ID	Issue Reported	Downtime (min)	Operator

Annexure-2: Troubleshooting Checklist

Checkpoints	Status	Remarks
Power Supply
Sensor Functionality
Nozzle Blockage
Piston Stroke Accuracy
Motor RPM

Annexure-3: Trouble Resolution Form

Machine ID	Date	Issue	Root Cause	Corrective Action	QA Review

Revision History

Revision Date	Revision No.	Change Description	Reason	Approved By
10/04/2022	1.0	Initial version	First issue	QA Head
09/06/2025	2.0	Expanded checklist and new annexures	Annual review	QA Head