Capsule: SOP for Environmental Cleaning of Capsule Manufacturing Areas – V 2.0

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Capsule: SOP for Environmental Cleaning of Capsule Manufacturing Areas – V 2.0

Standard Operating Procedure for Environmental Cleaning of Capsule Manufacturing Areas

Department Capsule Manufacturing
SOP No. SOP/CM/129/2025
Supersedes SOP/CM/129/2022
Page No. Page 1 of 7
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 procedures for environmental cleaning of capsule manufacturing areas. This process ensures that the manufacturing environment remains free from contamination and complies with Good Manufacturing Practices (GMP). Environmental cleaning is essential for maintaining product quality and preventing cross-contamination between batches.

2. Scope

This SOP applies to all areas in the capsule manufacturing department, including the production floor, packaging areas, equipment storage areas, and other critical zones. It defines the steps for cleaning the surfaces, floors, equipment, and surrounding environments after each production cycle to meet cleanliness standards.

3. Responsibilities

  • Production Operators: Responsible for initiating the environmental cleaning process and ensuring that cleaning is carried out according to this SOP.
  • Cleaning Staff: Responsible for cleaning all surfaces, floors, equipment, and the surrounding areas as per the defined cleaning procedure.
  • Quality Control (QC) Team: Verifies that the environmental cleaning has been performed to the required standards and that no residues or contamination remain.
  • Quality Assurance (QA) Team: Ensures that the cleaning process complies with GMP standards and that the cleaning process is adequately documented and reviewed.
  • Maintenance Team: Ensures that all cleaning equipment is functioning correctly and ready for use during the cleaning process.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for overseeing the environmental cleaning process and ensuring that it is carried out according to this SOP. The QA Manager ensures that the process meets GMP standards and that the cleaning records are properly maintained.

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5. Procedure

5.1 Preparation for Environmental Cleaning

Before starting the cleaning process, complete the following steps:

  1. Turn Off All Equipment

    1. Ensure that all capsule manufacturing equipment is turned off and disconnected from the power supply to avoid electrical hazards during cleaning.
    2. Confirm that no materials or capsules are left in the manufacturing area.
  2. Gather Cleaning Materials

    1. Collect all necessary cleaning agents, such as detergents, disinfectants, and water, along with PPE (Personal Protective Equipment) required for the cleaning staff.
    2. Ensure that all cleaning agents are compatible with the surfaces being cleaned and are effective in removing contaminants.
  3. Inspect the Area

    1. Inspect the manufacturing area for any visible contamination, residue, or debris. Pay close attention to areas where materials may have spilled or accumulated.
    2. Ensure that cleaning supplies are in good condition and ready for use.
  4. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) to document the cleaning process, including operator details, areas cleaned, and cleaning times.

5.2 Environmental Cleaning Process

Follow these steps for environmental cleaning:

  1. Initial Rinse

    1. Rinse the area and equipment with warm water to remove any loose dust, powders, or residues from the surfaces.
    2. Ensure that all surfaces are thoroughly rinsed, including equipment, floors, and walls.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to all surfaces, including walls, floors, and equipment, and allow it to sit for the required time to break down any contaminants.
    2. Use soft brushes or sponges to scrub areas that may have built-up residues or sticky materials.
  3. Rinse with Clean Water

    1. After the cleaning solution has been applied and scrubbed, rinse the area thoroughly with clean water to remove all cleaning agents and debris.
    2. Ensure that the rinse water is effectively drained and does not cause pooling in the cleaning area.
  4. Disinfection (If Required)

    1. If needed, apply an appropriate disinfectant to the area and allow it to sit for the required time to eliminate microbial contamination.
    2. Follow the manufacturer’s instructions for proper use and dilution of the disinfectant.
  5. Final Rinse

    1. Perform a final rinse with clean water to remove any disinfectant residues and cleaning agents.
    2. Ensure that all surfaces are thoroughly rinsed and no cleaning agents remain in the manufacturing area.
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5.3 Drying the Manufacturing Area

Once the cleaning process is complete, the area should be dried:

  1. Dry the Surfaces

    1. Wipe down all surfaces with clean, dry, lint-free cloths to remove any excess water.
    2. If necessary, allow the area to air dry to ensure that all surfaces are completely dry before reassembling or starting the next production batch.
    3. Use fans or air dryers to speed up the drying process in large or hard-to-reach areas.

5.4 Post-Cleaning Inspection

After cleaning and drying, perform the following checks:

  1. Inspect for Residual Contamination

    1. Inspect the area and equipment for any remaining cleaning agents, dust, or debris. If contamination is found, repeat the cleaning process.
  2. Check for Proper Drying

    1. Ensure that the surfaces are completely dry and free from any water or cleaning solution residues.
  3. Test for Equipment Functionality

    1. Ensure that all equipment is reassembled, if necessary, and fully functional before the next production cycle begins.
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5.5 Documentation

Ensure that all actions are properly documented for traceability and compliance:

  1. Complete Cleaning Log

    1. Record all cleaning actions, including operator details, cleaning times, areas cleaned, and any deviations from the standard procedure in the Cleaning Log (Annexure-1).
  2. Post-Cleaning Inspection

    1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (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. Equipment Inspection Log (Annexure-2)
  3. Maintenance Log (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-1: Cleaning Log

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Completed environmental cleaning of manufacturing area No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Mixer 001 02/02/2025 No defects found, fully sanitized Jane Smith 02/02/2026

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Mixer 001 02/02/2025 Checked air ventilation system, cleaned filters John Doe 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 steps and added inspection checks Improved process accuracy QA Head
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