Capsule: SOP for Routine Cleaning of Airlocks in Capsule Manufacturing Areas – V 2.0

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Capsule: SOP for Routine Cleaning of Airlocks in Capsule Manufacturing Areas – V 2.0

Standard Operating Procedure for Routine Cleaning of Airlocks in Capsule Manufacturing Areas

Department Capsule Manufacturing
SOP No. SOP/CM/141/2025
Supersedes SOP/CM/141/2022
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 routine cleaning procedure for airlocks in capsule manufacturing areas. Airlocks are critical to maintaining the cleanroom environment by preventing contamination between different areas. Proper cleaning of these airlocks ensures compliance with GMP, reduces the risk of cross-contamination, and maintains product quality.

2. Scope

This SOP applies to all airlocks in the capsule manufacturing areas, including those between different processing zones, raw material areas, and packaging zones. It covers the routine cleaning of airlocks to ensure they are free from dust, residue, and contamination before and after use.

3. Responsibilities

  • Production Operators: Responsible for performing the routine cleaning of airlocks and ensuring the area is properly cleaned and maintained.
  • Cleaning Staff: Responsible for executing the cleaning tasks using the appropriate cleaning materials and methods as per this SOP.
  • Quality Control (QC) Team: Ensures that the cleaning process meets the required standards and verifies that no residues are left in the airlocks after cleaning.
  • Quality Assurance (QA) Team: Reviews the cleaning logs and inspection reports to ensure compliance with GMP standards and provides oversight of the cleaning activities.
  • Production Supervisor: Oversees the cleaning of the airlocks and ensures that all cleaning procedures are completed properly before the airlocks are put back into use.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring the cleaning of airlocks according to this SOP. The QA Manager ensures that cleaning activities are performed in compliance with GMP and regulatory guidelines. The Waste Management Officer is accountable for overseeing the disposal of cleaning residues generated from the airlock cleaning process.

5. Procedure

5.1 Preparation for Cleaning Airlocks

Before starting the cleaning process, complete the following preparation steps:

  1. Turn Off Equipment and Isolate Airlock

    1. Turn off the airlock system and isolate it from any active processes to prevent contamination during cleaning.
    2. Ensure that no other equipment or production materials are in the vicinity of the airlock to avoid accidental contamination.
  2. Gather Cleaning Materials

    1. Collect all necessary cleaning agents (detergents, disinfectants) and cleaning tools (non-abrasive sponges, lint-free cloths, brushes, etc.).
    2. Ensure the cleaning agents are appropriate for the airlock material and do not cause damage or degradation to the components.
  3. Inspect Airlock

    1. Before cleaning, inspect the airlock for visible contamination or residues that need to be removed.
    2. Note any areas requiring special attention during the cleaning process, such as seals, hinges, and filters.

5.2 Cleaning Process for Airlocks

Follow these steps to clean the airlock effectively:

  1. Initial Dusting

    1. Use a soft brush or vacuum cleaner to remove any dust, powder, or loose particles from the airlock surfaces.
    2. Ensure that all vents, openings, and seals are free from dust build-up that may hinder airlock functionality.
  2. Apply Cleaning Solution

    1. Apply a cleaning solution to all internal and external surfaces of the airlock.
    2. Use a non-abrasive sponge or cloth to scrub all surfaces, paying attention to areas where residue may have accumulated, such as door seals and edges.
  3. Rinse with Clean Water

    1. Rinse all cleaned areas with clean water to remove any cleaning solution residues.
    2. Ensure that no detergent residues are left on the airlock surfaces, as this could affect air quality and product integrity.
  4. Disinfect (if required)

    1. If necessary, apply a disinfectant to all surfaces of the airlock, especially if the airlock is located in a critical area where contamination could be a concern.
    2. Allow the disinfectant to sit on the surfaces for the recommended time before rinsing thoroughly with clean water.
  5. Dry the Equipment

    1. Use clean, lint-free cloths to wipe down all surfaces and remove excess moisture.
    2. If required, use compressed air or a drying unit to ensure the airlock is completely dry before reassembly.
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5.3 Post-Cleaning Inspection

After cleaning, perform the following inspections to ensure that the airlock is properly cleaned and safe for use:

  1. Visual Inspection

    1. Visually inspect the airlock to ensure that all residues and cleaning agents have been removed.
    2. Check for any signs of contamination or wear and tear on the airlock components.
  2. Functional Check

    1. Perform a functional test on the airlock to ensure it is operating correctly after cleaning.
    2. Check that the airlock opens and closes properly and that all seals are intact.
  3. Document Cleaning Results

    1. Record all cleaning actions, including the date, operator, and any issues encountered, in the Cleaning Log (Annexure-1).
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5.4 Documentation

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

  1. Complete Cleaning Log

    1. Document all cleaning actions in the Cleaning Log (Annexure-1), including the date, operator name, and any issues found during cleaning.
  2. Inspection Report

    1. Record the results of the post-cleaning inspection, including functional test results, in the Inspection Report (Annexure-2).

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-1)
  2. Post-Cleaning Inspection Report (Annexure-2)

8. References

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

9. SOP Version

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Cleaning Log

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

Annexure-2: Post-Cleaning Inspection Report

Airlock ID Inspection Date Inspection Results Operator Next Maintenance Due
Airlock 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 process steps Enhanced cleaning process for airlocks QA Head
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