Capsule: SOP for Cleaning Vacuum Systems Used in Capsule Filling – V 2.0

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Capsule: SOP for Cleaning Vacuum Systems Used in Capsule Filling – V 2.0

Standard Operating Procedure for Cleaning Vacuum Systems Used in Capsule Filling

Department Capsule Manufacturing
SOP No. SOP/CM/144/2025
Supersedes SOP/CM/144/2022
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 outline the cleaning procedure for vacuum systems used in capsule filling. Vacuum systems play a crucial role in maintaining air flow and preventing contamination during capsule manufacturing. Proper cleaning is essential to ensure the system’s functionality, prevent cross-contamination, and ensure that the vacuum system operates within GMP standards.

2. Scope

This SOP applies to the cleaning of all vacuum systems used in capsule filling processes. This includes systems used for dust collection, air filtration, and material transport. It outlines the procedures for removing contaminants, cleaning the components, and maintaining the integrity of the system to ensure it performs efficiently in the manufacturing environment.

3. Responsibilities

  • Production Operators: Responsible for ensuring that vacuum systems are cleaned in accordance with this SOP, documenting the cleaning process, and ensuring that equipment is free from contaminants before reuse.
  • Cleaning Staff: Assist with cleaning tasks, ensuring that all parts of the vacuum system are cleaned properly using appropriate materials and techniques.
  • Quality Control (QC) Team: Ensures that vacuum systems are cleaned in compliance with GMP and verifies the cleanliness and proper functioning of the systems after cleaning.
  • Quality Assurance (QA) Team: Reviews cleaning documentation to ensure that it complies with regulatory requirements and provides oversight for the cleaning process.
  • Maintenance Team: Responsible for inspecting vacuum systems after cleaning to ensure they are in proper working order and ready for use.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that vacuum systems are cleaned according to this SOP. The QA Manager ensures that cleaning activities meet GMP standards and that all documentation is complete and accurate.

5. Procedure

5.1 Preparation for Cleaning Vacuum Systems

Before beginning the cleaning process, follow the steps below:

  1. Turn Off and Isolate Equipment

    1. Ensure the vacuum system is turned off and safely isolated from any active processes. Disconnect the system from electrical and air supply sources to avoid hazards during cleaning.
    2. Ensure that the area around the vacuum system is clear of any equipment or materials that could be accidentally contaminated during cleaning.
  2. Gather Cleaning Materials

    1. Collect appropriate cleaning materials such as detergents, disinfectants, non-abrasive brushes, microfiber cloths, and gloves.
    2. Ensure that cleaning solutions are compatible with the vacuum system components and do not damage any sensitive parts of the system.
  3. Inspect Vacuum System

    1. Inspect the vacuum system for visible contamination, leaks, or damage that may require special attention during the cleaning process.
    2. Document any issues found during the inspection in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Vacuum Systems

Follow these steps to clean the vacuum system:

  1. Remove Dust and Debris

    1. Using a soft brush or vacuum, gently remove any accumulated dust or debris from the vacuum system components, including hoses, filters, and inlets.
    2. Ensure that all accessible surfaces are free from debris that could interfere with the system’s operation or contaminate future batches.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to all components that require cleaning. Use a soft cloth or sponge to clean surfaces, ensuring that no cleaning residue remains on any parts.
    2. Pay extra attention to areas that come into direct contact with raw materials or dust collection parts.
  3. Clean Filters and Hoses

    1. If the vacuum system has filters or removable components, clean them by soaking and scrubbing gently with a cleaning solution, or replace them if necessary.
    2. For hoses, ensure they are free from clogs or accumulated materials that may obstruct airflow.
  4. Rinse and Dry

    1. Rinse all components thoroughly with clean water to remove any remaining cleaning solution or residue.
    2. Use clean, lint-free cloths or compressed air to dry all parts completely, ensuring that no moisture remains on sensitive components.
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5.3 Post-Cleaning Inspection

After cleaning, the following inspections should be performed:

  1. Visual Inspection

    1. Inspect all cleaned components for any signs of contamination, damage, or missed cleaning.
    2. Ensure that filters, hoses, and other parts are clean and intact.
  2. Functional Check

    1. Perform a functionality test of the vacuum system to verify that it is operating properly and that airflow is unobstructed.
    2. Ensure that the system is functioning efficiently without any unusual noises or leaks.
  3. Document Cleaning Results

    1. Record all cleaning actions, including the date, operator name, and any issues found during inspection, in the Cleaning Log (Annexure-2).
    2. Document any necessary repairs or adjustments made during the inspection process in the Equipment Maintenance Log (Annexure-1).

5.4 Documentation

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

  1. Complete Cleaning Log

    1. Document all cleaning actions, including the date, operator name, and specific cleaning tasks completed, in the Cleaning Log (Annexure-2).
  2. Inspection Report

    1. Record the results of the post-cleaning inspection, including the functionality check and any corrective actions taken, in the Post-Cleaning Inspection Report (Annexure-3).
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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

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

Annexure-3: Post-Cleaning Inspection Report

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

Annexure-1: Equipment Maintenance Log

Equipment ID Maintenance Date Maintenance Details Operator Next Inspection Date
Vacuum System 001 02/02/2025 Performed routine maintenance and cleaning 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 methodology QA Head
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