Operation and Maintenance of Gel Filling and Sealing Machine

1) Purpose

The purpose of this SOP is to outline the procedures for operating and maintaining the gel filling and sealing machine to ensure efficient and accurate filling and sealing of gel formulations.

2) Scope

This SOP applies to all personnel involved in the operation, cleaning, and maintenance of the gel filling and sealing machine in the manufacturing facility.

3) Responsibilities

It is the responsibility of production operators, maintenance staff, and quality control personnel to follow this SOP to ensure proper operation and maintenance of the gel filling and sealing machine.

4) Procedure

4.1 Preparation

1. Ensure the work area and equipment are clean and sanitized before starting the filling and sealing process.
2. Verify the availability and integrity of gel formulations ready for filling.
3. Inspect the gel filling and sealing machine, including filling nozzles and sealing mechanisms, to ensure they are clean and properly set up.

4.2 Filling and Sealing Process

1. Set up the filling parameters such as fill volume, speed, and container specifications according to product specifications.
2. Load the gel containers onto the machine conveyor and start the filling and sealing process.
3. Monitor the filling and sealing process to ensure accurate filling and proper sealing of gel containers.

4.3 Cleaning and Maintenance

1. Stop the gel filling and sealing machine after completing the filling and sealing batch.
2. Clean the filling nozzles, sealing heads, and conveyor belts thoroughly to remove any gel residues.
3. Perform routine maintenance tasks such as lubrication of sealing mechanisms and inspection of conveyor belt tension.

5) Abbreviations, if any

N/A

6) Documents, if any

Batch production record, Cleaning log, Gel formulation specifications

7) Reference, if any

GMP guidelines, Manufacturer’s operating manual for gel filling and sealing machine

8) SOP Version

Version 1.0