operation of automatic and semi-automatic gel filling machines within the Gel Manufacturing department.

3. Responsibilities

• Production Operator: Responsible for machine setup, cleaning verification, and basic troubleshooting.
• Engineering Department: Provides technical support and maintenance assistance as needed.
• Quality Assurance: Ensures compliance through line clearance, in-process checks, and documentation review.

4. Accountability

The Head – Manufacturing is accountable for the implementation, training, and compliance of this SOP.

5. Procedure

5.1 Pre-Setup Checks

1. Ensure that the filling machine and accessories are visually clean and have been cleaned as per SOP/GM/054/2025.
2. Confirm that the equipment has been calibrated and is within its valid calibration period.
3. Verify availability of necessary tools, nozzles, tubes, and machine attachments specific to the batch size and packaging material.
4. Ensure the filling area is cleared and sanitized as per the environmental control SOP.

5.2 Line Clearance

1. Request QA to perform line clearance.
2. QA to ensure that the previous product remnants are removed and cleaning has been done effectively.
3. Document line clearance in the Line Clearance Record (Annexure-1).

5.3 Machine Setup

1. Install appropriate nozzle assembly based on the viscosity and packaging of the gel.
2. Adjust the height and position of the nozzle based on the tube or container size.
3. Connect feed lines securely to the bulk gel storage vessel or transfer tank.
4. Set filling volume according to Batch Manufacturing Record (BMR) specifications.
5. Secure any attachments like plunger system, air eliminators, or level sensors.

5.4 Trial Run

1. Run a dry trial using distilled water to ensure proper fill volume and nozzle alignment.
2. Verify fill volume using calibrated weighing balance (±2% tolerance).
3. Record trial results in the Setup Verification Sheet (Annexure-2).

5.5 Start of Batch Filling

1. Begin filling the first 10 units with actual gel product and send them to QA for in-process testing.
2. Proceed with the batch only after QA approval.
3. Monitor machine performance and ensure consistent fill volume, minimal air entrapment, and proper sealing.

5.6 In-Process Checks

1. Production operator must monitor every 30 minutes for fill weight, tube sealing, and labeling accuracy.
2. Record data in the In-Process Monitoring Logbook.

5.7 Post-Use Steps

1. After completion, disconnect all connections and remove residual product safely.
2. Perform cleaning as per SOP/GM/054/2025 and update cleaning records.
3. Mark the equipment as “Cleaned” with date and time.

6. Abbreviations

• SOP: Standard Operating Procedure
• QA: Quality Assurance
• BMR: Batch Manufacturing Record
• GMP: Good Manufacturing Practice

7. Documents

1. Batch Manufacturing Record (BMR)
2. Line Clearance Record – Annexure-1
3. Setup Verification Sheet – Annexure-2
4. In-Process Monitoring Logbook
5. Equipment Cleaning Record

8. References

• ICH Q7: Good Manufacturing Practice Guidance
• 21 CFR Part 211 – US FDA Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

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

11. Annexures

Annexure-1: Line Clearance Record

Date	Machine ID	Product Name	Previous Product Removed	Cleaning Verified	QA Signature
			Yes / No	Yes / No

Annexure-2: Setup Verification Sheet

Date	Operator Name	Trial Material	Target Volume	Measured Volume	Within Tolerance	Remarks
		Distilled Water / Gel			Yes / No

Revision History

Revision Date	Revision No.	Details	Reason	Approved By
01/05/2022	1.0	Initial version	New SOP	QA Head
02/06/2025	2.0	Included annexures and in-process monitoring section	Periodic Review	QA Head