Capsule: SOP for Cleaning and Sanitizing Granulation Equipment – V 2.0

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Capsule: SOP for Cleaning and Sanitizing Granulation Equipment – V 2.0

Standard Operating Procedure for Cleaning and Sanitizing Granulation Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/122/2025
Supersedes SOP/CM/122/2022
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 define the procedure for cleaning and sanitizing granulation equipment used in capsule manufacturing. Effective cleaning and sanitization of granulation equipment are essential to prevent cross-contamination, maintain product quality, and ensure compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all granulation equipment used in the capsule manufacturing process, including mixers, blenders, and any associated components. It describes the cleaning and sanitizing process after each batch to ensure that the equipment is free of residues and contaminants.

3. Responsibilities

  • Production Operators: Responsible for cleaning and sanitizing granulation equipment as per this SOP, including disassembling, cleaning, sanitizing, and reassembling the equipment.
  • Quality Control (QC) Team: Ensures that the cleaning and sanitization process meets required standards and verifies that no contaminants remain on the equipment.
  • Quality Assurance (QA) Team: Ensures that the cleaning and sanitization procedures comply with GMP guidelines and reviews the cleaning logs for completeness and accuracy.
  • Maintenance Team: Responsible for inspecting and repairing any parts of the equipment that may be damaged during cleaning and ensuring that the equipment is reassembled correctly after sanitization.
  • Production Supervisor: Oversees the cleaning process, ensuring that all steps are followed, and confirms that the granulation equipment is ready for the next production batch.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the granulation equipment is cleaned and sanitized in accordance with this SOP. The QA Manager is accountable for verifying that the process complies with GMP standards and ensuring proper documentation is maintained.

5. Procedure

5.1 Preparation for Cleaning

Before starting the cleaning process, ensure the following steps are completed:

  1. Turn Off the Equipment

    1. Ensure that the granulation equipment is powered off and disconnected from the power supply.
    2. Ensure all material is removed from the equipment.
  2. Gather Cleaning Materials

    1. Collect the required cleaning materials, including approved cleaning agents, clean water, soft brushes, sponges, lint-free cloths, and PPE (Personal Protective Equipment).
    2. Ensure that the cleaning agents are non-corrosive and compatible with the materials of the equipment.
  3. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) to record all cleaning actions, the name of the operator, date, and any deviations observed during the process.

5.2 Disassembling the Granulation Equipment

If required, disassemble the equipment for thorough cleaning:

  1. Remove Components for Cleaning

    1. Carefully disassemble the granulation equipment, including removable parts such as paddles, trays, and mixing blades, to ensure a thorough cleaning.
    2. Take care not to damage any components during disassembly.
  2. Label Components for Reassembly

    1. Label each disassembled component to ensure correct reassembly after cleaning and sanitization.
  3. Place Components in Cleaning Area

    1. Place all disassembled components in the designated cleaning area to ensure effective cleaning and sanitization.

5.3 Cleaning Process

Follow the steps below to clean the granulation equipment:

  1. Initial Rinse

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

    1. Apply an approved cleaning agent to the surfaces of the equipment. Use soft brushes and sponges to scrub all surfaces, including hard-to-reach areas.
  3. Rinse with Warm Water

    1. Rinse the equipment thoroughly with warm water to remove any cleaning agents and residues.
    2. Ensure that no cleaning agents remain on any of the components.
  4. Disinfect (If Required)

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

    1. Perform a final rinse with clean water to ensure that no disinfectant or cleaning agents remain on the equipment.
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5.4 Drying and Reassembly

After cleaning, follow these steps:

  1. Dry the Components

    1. Dry the equipment components with a clean, dry, lint-free cloth. Allow components to air dry completely if necessary.
  2. Reassemble the Equipment

    1. Once the components are dry, carefully reassemble the granulation equipment, ensuring that all parts are correctly installed and securely fastened.

5.5 Post-Cleaning Inspection

Once the equipment is cleaned and reassembled, conduct the following checks:

  1. Inspect for Residual Contamination

    1. Visually inspect the granulation equipment for any remaining cleaning agents, dust, or contaminants. If any residues are found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all parts of the equipment are correctly reassembled and securely fastened.
  3. Test Run

    1. Perform a test run of the granulation equipment to ensure it is functioning properly before the next batch is processed.
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5.6 Documentation

Record all actions in the following logs for traceability and compliance:

  1. Complete Cleaning and Sanitization Log

    1. Document all cleaning and sanitization actions, including the date, time, operator, and 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 and sanitized granulation equipment No residue found

Annexure-2: Equipment Inspection Log

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

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Granulator 001 02/02/2025 Replaced seals and cleaned the internal components 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 post-cleaning inspection Improved sanitization accuracy QA Head
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