Standard Operating Procedure for Batch Coding Machine Operation

1) Purpose

The purpose of this SOP is to provide a detailed procedure for the operation and maintenance of the Batch Coding Machine used in the manufacturing of ocular dosage forms.

2) Scope

This SOP applies to the Batch Coding Machine used in the production of sterile ocular dosage forms within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, cleaning, and maintenance of the Batch Coding Machine. The equipment operator is responsible for following the procedure, and the maintenance team is responsible for regular maintenance and calibration.

4) Procedure

4.1 Preparation

1. Ensure the batch coding machine and surrounding area are clean and sanitized.
2. Verify that all necessary materials (coding ink, coding ribbon) and equipment are available and within expiry dates.
3. Check that the batch coding machine is connected to the appropriate power supply and is functioning properly.

4.2 Operation

1. Turn on the batch coding machine and allow it to perform its self-checks.
2. Set the parameters (batch number, expiry date) on the machine control panel.
3. Load the products (eye drop bottles, ointment tubes, etc.) into the coding area of the machine.
4. Initiate the coding process by pressing the start button on the machine.
5. Monitor the coding process to ensure accurate and legible coding is applied to each product.
6. Verify the coded information against the batch records.

4.3 Post-Operation

1. Turn off the batch coding machine and disconnect it from the power supply.
2. Clean the coding area and the surrounding machine parts as per the cleaning procedure.
3. Record the operation details, including batch numbers and coding details, in the batch record logbook.

4.4 Maintenance

1. Regularly inspect the batch coding machine for ink levels and cleanliness.
2. Perform preventive maintenance as per the manufacturer’s recommendations.
3. Replace coding ribbons and inks according to the schedule to maintain clear and consistent coding.
4. Calibrate the machine periodically to ensure accurate coding.

5) Abbreviations, if any

None

6) Documents, if any

1. Batch record logbook
2. Maintenance record
3. Calibration record

7) Reference, if any

GMP Guidelines for pharmaceutical production and equipment handling.

8) SOP Version

Version 1.0