Capsule: SOP for Cleaning of Encapsulation Machine Sensors – V 2.0

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Capsule: SOP for Cleaning of Encapsulation Machine Sensors – V 2.0

Standard Operating Procedure for Cleaning of Encapsulation Machine Sensors

Department Capsule Manufacturing
SOP No. SOP/CM/140/2025
Supersedes SOP/CM/140/2022
Page No. Page 1 of 5
Issue Date 01/02/2025
Effective Date 05/02/2025
Review Date 01/02/2026

1. Purpose

The purpose of this SOP is to ensure the effective cleaning of sensors used in encapsulation machines. These sensors play a crucial role in the accurate operation of capsule filling machines, and proper cleaning is necessary to avoid inaccuracies caused by dust or product residues. This SOP provides a step-by-step process for cleaning sensors to ensure their optimal performance and longevity.

2. Scope

This SOP applies to all sensors in encapsulation machines used in the capsule manufacturing process. It covers the cleaning of sensors involved in the monitoring and control of capsule filling, sealing, and other critical processes. The procedure ensures that sensors remain free of contaminants that could impact their performance.

3. Responsibilities

  • Production Operators: Responsible for performing the cleaning of sensors in encapsulation machines, ensuring that all steps are followed as per this SOP.
  • Cleaning Staff: Assist with the cleaning of sensors, ensuring that appropriate tools and cleaning solutions are used.
  • Quality Control (QC) Team: Responsible for inspecting cleaned sensors to ensure that they are free from residues and functioning properly.
  • Quality Assurance (QA) Team: Ensures that cleaning processes are in compliance with GMP and verifies that cleaning documentation is maintained properly.
  • Production Supervisor: Oversees the cleaning process and ensures that sensors are cleaned in a timely and effective manner before machine re-use.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that encapsulation machine sensors are cleaned according to this SOP. The QA Manager ensures that the cleaning of sensors meets GMP standards and reviews the cleaning documentation to ensure compliance.

5. Procedure

5.1 Preparation for Cleaning Encapsulation Machine Sensors

Before beginning the cleaning process, the following preparatory steps must be completed:

  1. Turn Off and Disconnect Equipment

    1. Ensure that all equipment is powered off and disconnected from the power source to prevent electrical hazards during the cleaning process.
    2. Disconnect any cables or connections leading to the sensors to avoid damage during cleaning.
  2. Gather Cleaning Materials

    1. Collect necessary cleaning materials such as soft brushes, lint-free cloths, cleaning solutions, and protective gloves.
    2. Ensure that all cleaning agents are suitable for the sensor components and will not cause damage to sensitive parts of the machine.
  3. Inspect the Sensors for Visible Contamination

    1. Before cleaning, check the sensors for visible contamination or residue that may need to be removed. This may include dust, product residues, or moisture.
    2. Record any issues or damage found during the inspection in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Encapsulation Machine Sensors

Follow these steps to clean the encapsulation machine sensors effectively:

  1. Initial Dusting

    1. Gently use a soft brush or compressed air to remove any loose dust or particles from the sensors and surrounding areas.
    2. Be cautious not to damage delicate components while brushing or blowing air onto the sensors.
  2. Apply Cleaning Solution

    1. Use a clean cloth dampened with an appropriate cleaning solution to wipe down the sensors.
    2. Gently wipe the sensors to remove any residues from the previous production run. Avoid excessive moisture, which could damage the sensors.
  3. Clean Sensitive Parts

    1. Use a non-abrasive cloth or brush to clean any sensitive parts of the sensors, such as the sensor lenses or electronic connections.
    2. If necessary, use a specialized cleaning solution designed for electronic components to ensure no damage occurs to the sensitive parts of the sensors.
  4. Rinse and Dry

    1. Use a dry cloth to wipe down all parts of the sensors and remove any excess moisture or cleaning solution.
    2. Ensure that the sensors are completely dry before reassembling the equipment and reactivating the system.
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5.3 Post-Cleaning Inspection

After cleaning, perform the following inspections to ensure that the sensors are ready for use:

  1. Visual Inspection

    1. Visually inspect the sensors to confirm that they are free from dust, residue, and moisture.
    2. Check that all sensitive parts, such as lenses and connectors, are clean and undamaged.
  2. Functionality Check

    1. Perform a functionality check on the sensors to ensure they are working correctly and that no issues were caused during cleaning.
    2. Test the sensor readings and make sure they are within the normal operating range.
  3. Document Cleaning Results

    1. Document the cleaning process, including the date, the operator’s name, and any issues found during inspection, in the Cleaning Log (Annexure-2).
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5.4 Documentation

Ensure that all cleaning activities are documented for traceability and compliance:

  1. Complete Cleaning Log

    1. Record all cleaning actions, including the date, operator details, and any issues encountered during the cleaning process, in the Cleaning Log (Annexure-2).
  2. Inspection Report

    1. Document the results of the post-cleaning inspection, including the functionality check, in the Equipment Inspection Log (Annexure-3).

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)

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

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Completed cleaning of sensors No issues found

Annexure-3: Post-Cleaning Inspection Report

Sensor ID Inspection Date Inspection Results Operator Next Calibration Due
Sensor 001 02/02/2025 Clean and ready for use 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 procedure steps Enhanced cleaning process QA Head
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