Standard Operating Procedure for Thermoforming 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 thermoforming machine to ensure proper packaging of ocular dosage forms.

2) Scope

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

3) Responsibilities

Production personnel are responsible for operating the thermoforming machine and ensuring that ocular dosage forms are packaged securely and correctly. Quality control personnel are responsible for verifying the integrity of packaged products and compliance with SOPs.

4) Procedure

4.1 Preparation for Thermoforming

1. Ensure the thermoforming area is clean, organized, and free from contaminants.
2. Verify the availability and condition of all packaging materials, such as thermoforming films and trays.
3. Set up the thermoforming machine according to the product specifications and batch records.
4. Record the batch number, product name, and quantity of units to be packaged in the batch production log.

4.2 Thermoforming Process

1. Preparation of Thermoforming Equipment
   1. Calibrate the thermoforming machine to ensure proper settings (temperature, forming depth, etc.).
   2. Load the thermoforming film and set up the trays according to the batch record instructions.
2. Forming and Packaging Operation
   1. Initiate the thermoforming process and monitor the machine for proper operation.
   2. Verify each formed tray for completeness and conformity to product specifications.
3. Quality Control Checks
   1. Take samples of packaged units for quality control testing, including visual inspection and packaging integrity.
   2. Record the results of quality control tests in the batch production log.
   3. If any units fail quality control tests, investigate and take corrective actions before proceeding.
4. Finalization and Storage
   1. Remove the packaged units from the thermoforming machine and inspect them for any defects or abnormalities.
   2. Label the packaged units with the batch number, product name, and expiry date.
   3. Transfer the packaged units to the designated storage area under controlled conditions.

4.3 Cleaning and Maintenance

1. Clean the thermoforming 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 thermoforming process, 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 packaging 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 packaging 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