Capsule: SOP for Cleaning Calibration Tools for Capsule Equipment – V 2.0

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Capsule: SOP for Cleaning Calibration Tools for Capsule Equipment – V 2.0

Standard Operating Procedure for Cleaning Calibration Tools for Capsule Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/150/2025
Supersedes SOP/CM/150/2022
Page No. Page 1 of 6
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to establish a procedure for cleaning calibration tools used in capsule manufacturing equipment. Calibration tools must be kept free of contamination and residues to maintain the accuracy of measurements and ensure the proper functioning of the equipment. This procedure helps ensure that calibration tools are properly cleaned between uses, maintaining GMP compliance and product quality.

2. Scope

This SOP applies to the cleaning of all calibration tools used for capsule manufacturing equipment, including measuring instruments, gauges, and any other tools used to ensure the accuracy of machine operations. It ensures that all tools are cleaned to prevent contamination and maintain their proper functioning.

3. Responsibilities

  • Production Operators: Responsible for cleaning the calibration tools following the SOP and ensuring that all tools are free from contamination before use.
  • Cleaning Staff: Assists with the cleaning of calibration tools and ensures that the cleaning procedure is followed accurately.
  • Quality Control (QC) Team: Verifies that the calibration tools are clean and ready for use before the next calibration or machine adjustment process.
  • Quality Assurance (QA) Team: Ensures that cleaning procedures are documented and compliant with GMP standards and regulatory requirements.
  • Maintenance Team: Assists with inspecting and testing the calibration tools after cleaning to ensure they are in good working condition.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that all calibration tools are cleaned in accordance with this SOP. The QA Manager is responsible for reviewing the cleaning logs and ensuring compliance with GMP standards.

5. Procedure

5.1 Preparation for Cleaning Calibration Tools

Before beginning the cleaning process, ensure that the following preparations are made:

  1. Turn Off and Isolate Tools

    1. Ensure that all calibration tools are turned off and disconnected from any active equipment or power sources.
    2. Ensure that all equipment using these tools is safely turned off and no longer in operation.
  2. Gather Cleaning Materials

    1. Collect all necessary cleaning materials, including lint-free cloths, brushes, approved cleaning agents, and disinfectants that will not damage the tools.
    2. Ensure that the cleaning agents are compatible with the materials of the calibration tools and will not leave residues.
  3. Inspect Calibration Tools

    1. Inspect each calibration tool for visible damage, residues, or wear. Any tool that appears damaged or malfunctioning should be reported and repaired before cleaning.
    2. Document any damage or required maintenance in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Calibration Tools

Follow these steps to properly clean calibration tools:

  1. Remove Residues

    1. Use a lint-free cloth, soft brush, or vacuum to remove any visible residues, dust, or debris from the surface of the calibration tools.
    2. Ensure that no particles remain in crevices or hidden areas, as this can impact the accuracy of future measurements.
  2. Apply Cleaning Solution

    1. Apply a gentle, non-corrosive cleaning solution to the calibration tools. Use a non-abrasive cloth or sponge to wipe down the surfaces of the tools.
    2. Ensure that no cleaning agent residue remains on the tools, as it may interfere with their accuracy or functionality.
  3. Rinse with Clean Water

    1. Rinse the tools with clean water to remove any cleaning solution residue. Ensure that all cleaning agents are fully washed away.
    2. Be cautious to avoid introducing any contaminants during the rinse process.
  4. Disinfect Tools (if required)

    1. If necessary, apply an approved disinfectant to the tools and allow it to sit for the required contact time.
    2. Rinse the tools again to remove any disinfectant residues and ensure that they are free of any contamination.
  5. Dry Calibration Tools

    1. Dry the calibration tools using a lint-free cloth, ensuring that all parts are thoroughly dried and no moisture remains.
    2. If necessary, use compressed air or a drying unit to speed up the drying process and prevent water spots.
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5.3 Post-Cleaning Inspection

After cleaning, inspect the tools to ensure they are ready for use:

  1. Visual Inspection

    1. Inspect the calibration tools for cleanliness, ensuring that there are no residues, cleaning agents, or moisture left on any surfaces.
    2. Check for any visible damage, such as scratches, dents, or any signs of wear.
  2. Functional Check

    1. Ensure that the tools are functioning correctly by conducting a test calibration or functional check if applicable.
  3. Document Inspection Results

    1. Record the results of the inspection and any corrective actions in the Equipment Inspection Log (Annexure-2).

5.4 Documentation

Ensure proper documentation of the cleaning and inspection process:

  1. Cleaning Log

    1. Complete the cleaning log for each calibration tool, documenting the date, operator, cleaning actions performed, and any issues encountered.
  2. Post-Cleaning Inspection Report

    1. Complete the Post-Cleaning Inspection Report (Annexure-3) to document the inspection results and confirm that the tool is ready for use.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Cleaning Log (Annexure-2)
  2. Post-Cleaning Inspection Report (Annexure-3)
  3. Equipment Maintenance Log (Annexure-1)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-2: Cleaning Log

Tool ID Cleaning Date Operator Cleaning Action Comments
Tool 001 02/02/2025 John Doe Completed cleaning of calibration tool No issues found

Annexure-3: Post-Cleaning Inspection Report

Tool ID Inspection Date Inspection Results Operator Next Maintenance Due
Tool 001 02/02/2025 Clean and ready for use Jane Smith 02/02/2026

Annexure-1: Equipment Maintenance Log

Tool ID Maintenance Date Maintenance Details Operator Next Inspection Date
Tool 001 02/02/2025 Routine cleaning and maintenance Jane Smith 02/02/2026

Revision History:

Revision Date Revision No. Revision Details Reason for Revision Approved By
01/01/2024 1.0 Initial version New SOP Creation QA Head
01/02/2025 2.0 Updated cleaning process for tools Enhanced cleaning procedures QA Head
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