Standard Operating Procedure for Ampoule Sealing System 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 ampoule sealing system to ensure proper sealing of ampoules containing ocular dosage forms.

2) Scope

This SOP applies to all ampoule sealing systems used in the manufacturing of ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the ampoule sealing system and maintaining accurate records. Quality control personnel are responsible for verifying the sealing process and ensuring compliance with SOPs.

4) Procedure

4.1 Preparation for Ampoule Sealing

1. Ensure the sealing area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all equipment, utensils, and materials needed for the sealing process.
3. Calibrate the ampoule sealing system according to the manufacturer’s instructions to ensure proper sealing temperature and parameters.
4. Record the batch number, product name, and quantity of ampoules to be sealed in the batch production log.

4.2 Ampoule Sealing Process

1. Preparation of Sealing Equipment
   1. Assemble the sealing system components as per the manufacturer’s instructions.
   2. Sanitize all parts that come into contact with the ampoules using appropriate disinfectants.
   3. Set up the sealing system with the required sealing parameters (temperature, speed, etc.).
2. Sealing Operation
   1. Load the filled ampoules into the sealing system hopper or conveyor.
   2. Start the sealing system and begin sealing the ampoules.
   3. Monitor the sealing process to ensure proper and consistent sealing of ampoules.
   4. Perform in-process checks for sealing integrity at regular intervals.
3. Quality Control Checks
   1. Take samples of the sealed ampoules for quality control testing, including sealing integrity 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 sealed ampoules with the batch number, product name, and other required information.
   2. Package the labeled ampoules according to the packaging SOP.
   3. Store the packaged ampoules in a designated area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the ampoule sealing system and all associated equipment thoroughly after each batch according to the cleaning SOP.
2. Inspect the system 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 ampoule sealing process, including sealing 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 sealing.
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 sealing 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