Standard Operating Procedure for Sterilization Line for Inserts 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 sterilization line specifically designed for inserts, ensuring efficient and compliant production practices.

2) Scope

This SOP applies to the entire sterilization line dedicated to inserts within the pharmaceutical manufacturing facility.

3) Responsibilities

Production personnel are responsible for operating the sterilization line and ensuring that insert containers are sterilized effectively. Maintenance personnel are responsible for cleaning, maintaining, and calibrating the sterilization equipment.

4) Procedure

4.1 Preparation for Sterilization

1. Ensure the sterilization area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all materials, including containers and sterilization indicators.
3. Set up the sterilization line according to the product specifications and batch records.
4. Record the batch number, product name, and quantity of units to be sterilized in the batch production log.

4.2 Sterilization Line Operation

1. Setup and Calibration
   1. Perform initial setup and calibration of the sterilization line to ensure accurate sterilization parameters.
   2. Load the containers with inserts into the sterilization line according to the batch record instructions.
2. Sterilization Process
   1. Initiate the sterilization process and monitor the line for proper operation and sterilization parameters.
   2. Verify each sterilized container with inserts for compliance with sterilization standards.

4.3 Quality Control Checks

1. Take samples of sterilized containers with inserts for quality control testing, including sterility testing and visual inspection.
2. Record the results of quality control tests in the batch production log.
3. If any containers with inserts fail quality control tests, investigate and take corrective actions before proceeding.

4.4 Cleaning and Maintenance

1. Clean the sterilization line 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.

4.5 Documentation

1. Record the details of the sterilization line operation, including settings, 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 sterilization operation.
3. Attach a copy of the batch production log to the batch production record for traceability.

4.6 Review and Approval

1. The quality assurance department should review sterilization 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