Standard Operating Procedure for Operation of Bottle Washing Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a bottle washing machine in pharmaceutical manufacturing. This ensures thorough cleaning and sanitation of product containers while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of bottle washing machines within the pharmaceutical manufacturing facility.

3. Responsibilities

• Machine Operator: Responsible for following the procedures outlined in this SOP during machine operations.
• Supervisor: Oversees and verifies compliance with this SOP, including training and documentation.

4. Procedure

4.1. Pre-Operation Checks

1. Inspect the bottle washing machine for any visible damage, malfunctions, or defects. Report any issues to the supervisor.
2. Ensure that the machine is clean and free from any residues or contaminants from previous operations.
3. Verify that all necessary utilities (e.g., water, detergent) are available and functioning properly.

4.2. Set-Up

1. Position the bottle washing machine in the designated location for operation.
2. Load product containers onto the conveyor or infeed system, ensuring they are properly oriented and spaced for washing.
3. Adjust the machine settings, including water temperature, wash cycles, and drying parameters, according to the product specifications and batch record.

4.3. Washing Process

1. Start the bottle washing machine according to the manufacturer’s instructions and the parameters specified in the batch record.
2. Monitor the washing process closely to ensure that containers are thoroughly cleaned and sanitized.
3. Check for any residue, foreign particles, or visual defects on the containers and take corrective action as necessary.
4. Record the washing time, temperature, detergent usage, and any deviations from the standard procedure.

4.4. Drying and Post-Wash Checks

1. If the machine includes a drying step, ensure that containers are adequately dried according to specifications.
2. Stop the bottle washing machine when the washing and drying processes are completed or as directed by the supervisor.
3. Perform visual inspections of the cleaned containers to verify cleanliness and absence of defects.

4.5. Cleaning and Maintenance

1. Clean the bottle washing machine and associated equipment after use, following the cleaning procedure.
2. Perform routine maintenance as per the manufacturer’s recommendations to ensure the machine’s continued performance.

4.6. Documentation

Properly document all aspects of the bottle washing machine operation, including pre-operation checks, machine settings, washing parameters, and post-wash checks. Maintain records in a secure and accessible location for regulatory inspection.

5. Abbreviations

• GMP: Good Manufacturing Practices

6. Reference

[Insert any relevant references or standards applicable to the operation of bottle washing machines in the pharmaceutical industry.]

7. SOP Version

This is version 1.0 of the “Operation of Bottle Washing Machine SOP,” issued on [insert issuance date].