Standard Operating Procedure for Tube Sealing 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 tube sealing machine to ensure proper sealing of tubes containing ocular dosage forms.

2) Scope

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

3) Responsibilities

Production personnel are responsible for operating the tube sealing machine and ensuring that tubes are sealed correctly and securely. Quality control personnel are responsible for verifying the integrity of sealed tubes and compliance with SOPs.

4) Procedure

4.1 Preparation for Tube Sealing

1. Ensure the tube sealing area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all equipment, tools, and materials needed for the sealing process.
3. Set up the tube sealing machine according to the manufacturer’s instructions and specifications.
4. Record the batch number, product name, and quantity of tubes to be sealed in the batch production log.

4.2 Tube Sealing Process

1. Preparation of Tubes
   1. Inspect each tube for defects or damage before sealing.
   2. Load the filled tubes into the tube sealing machine conveyor or fixture.
2. Sealing Operation
   1. Set the sealing parameters on the machine control panel (temperature, pressure, sealing time, etc.).
   2. Initiate the sealing process and monitor the machine for proper operation.
   3. Verify each sealed tube for completeness and integrity.
3. Quality Control Checks
   1. Take samples of sealed tubes for quality control testing, including seal strength and visual inspection.
   2. Record the results of quality control tests in the batch production log.
   3. If any tubes fail quality control tests, investigate and take corrective actions before proceeding.
4. Finalization and Storage
   1. Remove the sealed tubes from the machine and inspect them for any defects or abnormalities.
   2. Label the sealed tubes with the batch number, product name, and expiry date.
   3. Transfer the sealed tubes to the designated storage area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the tube sealing machine and all associated equipment thoroughly after each batch according to the cleaning SOP.
2. Perform routine maintenance checks and ensure all parts are properly maintained and calibrated.
3. Document all cleaning and maintenance activities in the equipment logbook.

4.4 Documentation

1. Record the details of the tube sealing process, including sealing parameters, in-process checks, and quality control results, in the batch production log.
2. Ensure all records are signed and dated by the personnel responsible for the sealing operation.
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 review sealing procedures and records periodically 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 changes in procedures, regulations, or industry standards.

5) Abbreviations, if any

SOP: Standard Operating Procedure

QC: Quality Control

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