Standard Operating Procedure for Aseptic 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 aseptic filling machine to ensure sterile filling of ocular dosage forms.

2) Scope

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

3) Responsibilities

Production personnel are responsible for operating the aseptic filling machine and maintaining sterile conditions throughout the filling process. Quality control personnel are responsible for verifying the aseptic conditions and ensuring compliance with SOPs.

4) Procedure

4.1 Preparation for Aseptic Filling

1. Ensure the aseptic filling area is clean, organized, and sanitized according to standard operating procedures.
2. Verify the availability and condition of all equipment, utensils, and materials needed for the filling process.
3. Perform environmental monitoring and ensure the aseptic filling machine is properly set up and calibrated.
4. Record the batch number, product name, and quantity of ocular dosage forms to be filled in the batch production log.

4.2 Aseptic Filling Process

1. Preparation of Aseptic Filling Equipment
   1. Assemble and sanitize all components of the aseptic filling machine as per the manufacturer’s instructions.
   2. Set up the filling machine with the required filling parameters (volume, speed, etc.) under a laminar airflow hood or in a sterile environment.
   3. Perform initial checks to ensure all seals, valves, and filters are intact and functioning properly.
2. Filling Operation
   1. Load the sterile containers into the aseptic filling machine.
   2. Initiate the filling process and monitor the machine for proper operation.
   3. Verify the filled volumes and ensure accurate dispensing of the ocular dosage forms.
   4. Perform in-process checks to maintain the sterility and integrity of the filled containers.
3. Quality Control Checks
   1. Take samples of the filled ocular dosage forms for quality control testing, including sterility and fill volume.
   2. Record the results of the quality control tests in the batch production log.
   3. If any parameters are out of specification, initiate corrective actions and document them accordingly.
4. Finalization and Storage
   1. Complete the filling process and remove the filled containers from the aseptic filling machine.
   2. Label the containers with the batch number, product name, and other required information.
   3. Transfer the filled containers to the designated storage area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the aseptic filling 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 aseptic filling process, including filling 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 filling 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 filling 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

GMP: Good Manufacturing Practice

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