Capsule: SOP for Cleaning and Drying Capsule Counting Machines – V 2.0

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Capsule: SOP for Cleaning and Drying Capsule Counting Machines – V 2.0

Standard Operating Procedure for Cleaning and Drying Capsule Counting Machines

Department Capsule Manufacturing
SOP No. SOP/CM/124/2025
Supersedes SOP/CM/124/2022
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 standardized procedure for cleaning and drying capsule counting machines. Regular cleaning and drying of these machines are essential to maintain proper functioning, prevent contamination, and ensure the accuracy of the counting process, in compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule counting machines used in the manufacturing process. It outlines the necessary steps to clean and dry the machines thoroughly after each batch to ensure they are free from any residues or contaminants that could affect the quality of the capsules.

3. Responsibilities

  • Production Operators: Responsible for disassembling, cleaning, drying, and reassembling capsule counting machines according to this SOP.
  • Quality Control (QC) Team: Verifies the cleaning process and ensures the machine is free from contaminants before the next production run.
  • Quality Assurance (QA) Team: Ensures that the cleaning procedure follows GMP standards and reviews the cleaning records for compliance and accuracy.
  • Production Supervisor: Oversees the cleaning procedure and confirms that the counting machines are cleaned, dried, and ready for the next production cycle.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule counting machines are cleaned and dried according to this SOP. The QA Manager ensures compliance with GMP standards and verifies that the cleaning process is properly documented.

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5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning and drying process, the following steps should be completed:

  1. Turn Off the Equipment

    1. Ensure that the capsule counting machine is turned off and disconnected from the power supply to avoid any electrical hazards during cleaning.
    2. Make sure there are no capsules left in the counting machine.
  2. Gather Cleaning Materials

    1. Collect the necessary cleaning materials, including approved cleaning agents, warm water, soft brushes, lint-free cloths, and PPE (Personal Protective Equipment).
    2. Ensure that the cleaning agents are compatible with the machine materials and are effective in removing any contaminants.
  3. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) to document all actions taken, including operator details, date, and any deviations from the standard procedure.

5.2 Disassembling the Capsule Counting Machine

If required, disassemble the capsule counting machine for thorough cleaning:

  1. Remove Parts for Cleaning

    1. Carefully disassemble any removable parts, such as trays, hoppers, or other components, to ensure complete access for cleaning.
  2. Label Components for Reassembly

    1. Label each part to ensure that they are reassembled correctly after cleaning and drying.
  3. Place Parts in Cleaning Area

    1. Place all disassembled parts in the designated cleaning area to ensure they are cleaned effectively.

5.3 Cleaning Process

Follow these steps for cleaning the capsule counting machine:

  1. Initial Rinse

    1. Rinse the equipment and parts with warm water to remove any dust, debris, or residues from the previous batch.
    2. Ensure that all parts, including the internal surfaces, are thoroughly rinsed.
  2. Apply Cleaning Agents

    1. Apply an approved cleaning agent to all parts of the capsule counting machine, including the removable components. Use soft brushes or sponges to scrub all areas thoroughly.
  3. Rinse with Water

    1. Rinse the machine thoroughly with warm water to remove all cleaning agents and contaminants.
    2. Ensure that no cleaning agents remain on any of the machine components.
  4. Disinfection (If Required)

    1. If necessary, apply an appropriate disinfectant to the machine components to eliminate microbial contamination.
    2. Follow the manufacturer’s instructions for the proper application of disinfectants.
  5. Final Rinse

    1. Perform a final rinse with clean water to ensure that no disinfectant or cleaning agents remain on the machine.
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5.4 Drying the Capsule Counting Machine

Once cleaning is complete, follow these steps to dry the components:

  1. Drying the Components

    1. Use a clean, dry, lint-free cloth to dry the machine parts. Ensure that no water droplets remain on the equipment.
    2. If required, allow the parts to air dry in a clean environment to ensure that all moisture is removed.

5.5 Reassembling the Capsule Counting Machine

Once the components are dry, proceed to reassemble the capsule counting machine:

  1. Reassemble the Machine

    1. Carefully reassemble the machine and ensure all parts are correctly installed and securely fastened.

5.6 Post-Cleaning Inspection

After reassembly, perform the following checks:

  1. Inspect for Residual Contamination

    1. Inspect the machine to ensure that there are no remaining cleaning agents, dust, or residues. If contamination is found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all parts are correctly reassembled and that the machine is functioning as expected.
  3. Test Run

    1. Conduct a test run of the capsule counting machine to ensure it is working correctly before the next production batch begins.
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5.7 Documentation

Ensure that all actions are properly documented:

  1. Complete Cleaning and Sanitization Log

    1. Document all cleaning actions, including dates, times, operator details, and any actions taken 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 Cleaned capsule counting machine No residue found

Annexure-2: Equipment Inspection Log

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

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Counting Machine 001 02/02/2025 Replaced belts and cleaned internal parts 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 process and added drying steps Improved machine performance QA Head
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