Capsule: SOP for Cleaning Blender Machines Used in Capsule Production – V 2.0

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Capsule: SOP for Cleaning Blender Machines Used in Capsule Production – V 2.0

Standard Operating Procedure for Cleaning Blender Machines Used in Capsule Production

Department Capsule Manufacturing
SOP No. SOP/CM/138/2025
Supersedes SOP/CM/138/2022
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 ensure that blender machines used in the production of capsule formulations are cleaned thoroughly between batches. Effective cleaning is essential to prevent cross-contamination between different capsule formulations and to maintain product quality. This SOP outlines the cleaning process to ensure that blender machines are free from residues, dust, and contaminants before the next production run.

2. Scope

This SOP applies to all blender machines used in capsule production. The procedure covers the cleaning of equipment used to blend APIs (Active Pharmaceutical Ingredients) and excipients. The cleaning process ensures the removal of product residues and any other contaminants from the machine’s interior and exterior surfaces.

3. Responsibilities

  • Production Operators: Responsible for performing the cleaning of blender machines according to this SOP after every batch, ensuring that the equipment is thoroughly cleaned.
  • Cleaning Staff: Responsible for conducting the cleaning process using appropriate cleaning agents, ensuring that no residues are left on the equipment.
  • Quality Control (QC) Team: Responsible for inspecting the cleaned blender machines and verifying that they are free from residues and contamination before the next batch is processed.
  • Quality Assurance (QA) Team: Ensures that cleaning activities are performed according to GMP standards and reviews the cleaning logs for compliance.
  • Production Supervisor: Oversees the cleaning process to ensure that it is carried out according to the established schedule and that the equipment is cleaned properly before re-use.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that blender machines are cleaned according to this SOP. The QA Manager ensures that the cleaning process meets GMP requirements and reviews the cleaning documentation.

5. Procedure

5.1 Preparation for Cleaning Blender Machines

Before starting the cleaning process, the following preparatory steps must be completed:

  1. Turn Off and Disconnect Equipment

    1. Ensure that all equipment is turned off and disconnected from the power supply to prevent electrical hazards during cleaning.
    2. Remove any remaining blend from the machine, including API and excipients.
  2. Gather Cleaning Materials

    1. Collect the necessary cleaning agents such as detergents, disinfectants, and non-abrasive cleaning tools like brushes, sponges, and cloths.
    2. Ensure that the cleaning agents are safe to use on the machine parts and effective at removing product residues without causing damage.
  3. Inspect Blender Machine for Visible Contamination

    1. Inspect the machine thoroughly for visible contamination such as residue from the previous batch or dust accumulation.
    2. Note any areas requiring special attention during the cleaning process.

5.2 Cleaning Process for Blender Machines

Follow these steps to clean the blender machine effectively:

  1. Initial Rinse

    1. Rinse the blender machine’s internal surfaces with warm water to remove any loose residues or powder.
    2. Ensure that all exposed parts of the machine, including hoppers and mixing containers, are rinsed thoroughly.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to all machine parts that were in contact with the product. This includes the blades, hoppers, and mixing chambers.
    2. Use non-abrasive brushes, sponges, or cloths to scrub the surfaces and ensure that all residues are removed.
  3. Rinse with Clean Water

    1. After scrubbing, rinse the blender machine thoroughly with clean water to remove all detergent and cleaning solution residues.
    2. Ensure that no cleaning agents are left on the machine’s surfaces, as this could affect the next batch.
  4. Disinfection (if required)

    1. If required, apply a disinfectant to the blender machine surfaces to eliminate any microbial contamination.
    2. Allow the disinfectant to sit on the machine for the recommended duration, then rinse thoroughly with clean water to remove all disinfectant residues.
  5. Dry the Equipment

    1. Wipe down the machine surfaces with clean, lint-free cloths to remove any excess moisture.
    2. If necessary, use compressed air or drying equipment to ensure the machine is completely dry before reassembly.
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5.3 Post-Cleaning Inspection

After cleaning, inspect the blender machine to ensure that no residues remain:

  1. Visual Inspection

    1. Visually inspect all surfaces of the blender machine to ensure that they are clean and free from any residues or cleaning solution.
    2. If residues or cleaning solution are still present, repeat the cleaning process and document the issue in the Cleaning Log (Annexure-1).
  2. Functional Check

    1. Perform a functional check on the blender machine to ensure that all components are working properly after cleaning.
    2. Confirm that the machine is ready for the next batch by checking for proper operation and assembly of all parts.
  3. Document Cleaning Results

    1. Document the cleaning process in the Cleaning Log (Annexure-1), including the date, operator details, and inspection results.
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5.4 Documentation

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

  1. Complete Cleaning Log

    1. Document all cleaning actions, including the date, equipment cleaned, operator details, and any issues encountered in the Cleaning Log (Annexure-1).
  2. Inspection Report

    1. Record 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. 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

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 blender machine No residue found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Blender Machine 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 and inspection procedures Improved cleaning process QA Head
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