Standard Operating Procedure for Automatic Gel Filling Machine in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized procedure for the operation, cleaning, and maintenance of the automatic gel filling machine to ensure accurate and sterile filling of gels for ocular dosage forms.

2) Scope

This SOP applies to all automatic gel filling machines used in the manufacturing of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the automatic gel filling machine and maintaining accurate records. Quality control personnel are responsible for verifying the filling process and ensuring compliance with SOPs.

4) Procedure

4.1 Preparation for Gel Filling

1. Ensure the filling area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all equipment, utensils, and materials needed for the filling process.
3. Calibrate the automatic gel filling machine according to the manufacturer’s instructions to ensure proper filling parameters.
4. Record the batch number, product name, and quantity of gels to be filled in the batch production log.

4.2 Gel Filling Process

1. Preparation of Filling Equipment
   1. Assemble the filling machine components as per the manufacturer’s instructions.
   2. Sanitize all parts that come into contact with the gel using appropriate disinfectants.
   3. Set up the filling machine with the required filling parameters (volume, speed, etc.).
2. Filling Operation
   1. Load the gel formulation into the filling machine hopper or reservoir.
   2. Start the filling machine and begin the filling process.
   3. Monitor the filling process to ensure accurate and consistent filling of the gel.
   4. Perform in-process checks for fill volume and uniformity at regular intervals.
3. Quality Control Checks
   1. Take samples of the filled gels for quality control testing, including fill volume and visual inspection.
   2. Record the results of the quality control tests in the batch production log.
   3. If any parameters are out of specification, investigate and take corrective actions before proceeding.
4. Labeling and Packaging
   1. Label the filled gels with the batch number, product name, and other required information.
   2. Package the labeled gels according to the packaging SOP.
   3. Store the packaged gels in a designated area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the automatic gel filling machine and all associated equipment thoroughly after each batch according to the cleaning SOP.
2. Inspect the machine for any signs of wear or damage and perform necessary maintenance or repairs.
3. Record all cleaning and maintenance activities in the equipment logbook.

4.4 Documentation

1. Record the details of the gel filling process, including filling parameters, in-process checks, and quality control results, in the batch production log.
2. Ensure that all records are signed and dated by the personnel responsible for the filling.
3. Attach a copy of the batch production log to the batch production record for traceability.

4.5 Review and Approval

1. The quality assurance department should regularly review filling procedures and records to ensure compliance with SOPs and regulatory requirements.
2. Any discrepancies or deviations should be investigated, documented, and resolved promptly.
3. Review and update the SOP as necessary to reflect any changes in procedures, regulations, or industry standards.

5) Abbreviations, if any

SOP: Standard Operating Procedure

CAPA: Corrective and Preventive Actions

6) Documents, if any

1. Batch production log
2. Batch production record
3. Equipment logbook

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0