SOP Guide for Pharma

SOP for Operation of Bottle Inspection Machine

Auditor

Standard Operating Procedure for Operation of Bottle Inspection Machine

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to outline the procedure for the proper operation of a bottle inspection machine in pharmaceutical manufacturing. This ensures accurate and consistent inspection of product containers for defects and quality control while maintaining compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all personnel involved in the operation of bottle inspection 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 inspection 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., electricity, lighting) are available and functioning properly.
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4.2. Set-Up

  1. Position the bottle inspection machine in the designated location for operation.
  2. Adjust the machine settings, including inspection criteria and speed, according to the product specifications and batch record.
  3. Ensure that the conveyor or feed system is properly aligned with the machine for smooth bottle transfer.

4.3. Inspection Process

  1. Start the bottle inspection machine according to the manufacturer’s instructions
and the parameters specified in the batch record.
  • Feed product containers onto the conveyor or infeed system, ensuring they are properly oriented for inspection.
  • Monitor the inspection process closely to verify that containers are accurately and consistently inspected for defects.
  • Check for any defective containers, foreign particles, or other deviations and take corrective action as necessary.
  • Record the inspection time, inspection criteria, and any deviations from the standard procedure.

    • 4.4. Post-Inspection Checks

    1. Stop the bottle inspection machine when the inspection process is completed or as directed by the supervisor.
    2. Perform visual inspections of the containers to verify the accuracy of defect detection and quality control.
    3. Segregate and label any defective containers for further evaluation or disposal.

    4.5. Cleaning and Maintenance

    1. Clean the bottle inspection 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 inspection machine operation, including pre-operation checks, machine settings, inspection parameters, and post-inspection 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 inspection machines in the pharmaceutical industry.]

    7. SOP Version

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

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