Capsule: SOP for Cleaning Equipment Between Soft Gel and Hard Gelatin Batches – V 2.0

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Capsule: SOP for Cleaning Equipment Between Soft Gel and Hard Gelatin Batches – V 2.0

Standard Operating Procedure for Cleaning Equipment Between Soft Gel and Hard Gelatin Batches

Department Capsule Manufacturing
SOP No. SOP/CM/136/2025
Supersedes SOP/CM/136/2022
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 provide a standardized cleaning procedure for the equipment used in the production of soft gelatin and hard gelatin capsules. Cleaning is essential to avoid cross-contamination between different types of gelatin and ensure the quality and safety of the final product. This SOP ensures that all equipment is thoroughly cleaned before switching between soft and hard gelatin batches.

2. Scope

This SOP applies to all equipment used in the production of soft and hard gelatin capsules, including capsule filling machines, mixers, granulators, hoppers, and other related equipment. The procedure covers the steps for cleaning between the manufacturing of different types of gelatin-based capsules to prevent contamination.

3. Responsibilities

  • Production Operators: Responsible for performing the cleaning procedures as outlined in this SOP between soft and hard gelatin batches.
  • Cleaning Staff: Responsible for ensuring that all equipment is cleaned thoroughly according to the SOP and ensuring no residues are left from previous production runs.
  • Quality Control (QC) Team: Responsible for inspecting the equipment to ensure that no residues from the previous batch remain and that cleaning is completed to the required standards.
  • Quality Assurance (QA) Team: Ensures that cleaning activities are in compliance with GMP and reviews cleaning logs to confirm adherence to the SOP.
  • Production Supervisor: Oversees the cleaning process and ensures that the cleaning procedures are followed as per the established schedule and standard.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the cleaning of equipment between soft and hard gelatin batches is performed according to this SOP. The QA Manager ensures that cleaning is compliant with GMP standards and reviews all documentation and inspection results.

5. Procedure

5.1 Preparation for Cleaning Between Soft Gel and Hard Gelatin Batches

Before starting the cleaning process, complete the following preparations:

  1. Turn Off and Disconnect Equipment

    1. Ensure that all equipment is turned off and disconnected from the power supply to avoid electrical hazards during cleaning.
    2. Remove any remaining material, including soft gelatin and other substances, from the equipment.
  2. Gather Cleaning Materials

    1. Collect all necessary cleaning agents, such as detergents, disinfectants, and PPE (Personal Protective Equipment) like gloves, masks, and goggles.
    2. Ensure that the cleaning agents are suitable for removing both soft gelatin residues and any contaminants that could affect the hard gelatin batch.
  3. Inspect Equipment for Visible Contamination

    1. Inspect the equipment for any visible contamination, residues, or build-up from the previous soft gelatin batch.
    2. Note any areas that may require special attention during cleaning, such as crevices or intricate parts.

5.2 Cleaning Process for Equipment Between Soft Gel and Hard Gelatin Batches

Follow these steps to clean the equipment effectively:

  1. Initial Rinse

    1. Rinse all equipment with warm water to remove any loose residues from the previous batch.
    2. Ensure that the rinse water flows through all parts of the equipment, including hoppers, mixers, and filling machines.
  2. Apply Cleaning Solution

    1. Apply an appropriate cleaning solution to the equipment, ensuring that it reaches all surfaces that were in contact with the previous soft gelatin batch.
    2. Use non-abrasive brushes, sponges, or cloths to scrub and clean the surfaces, paying special attention to hard-to-reach areas.
  3. Rinse with Clean Water

    1. After scrubbing, rinse the equipment thoroughly with clean water to remove all traces of detergent and residues from the previous batch.
    2. Ensure that no detergent or cleaning agents remain on the equipment before proceeding to the next step.
  4. Disinfect Equipment (if required)

    1. If necessary, apply a disinfectant to the equipment to ensure the complete removal of any microbial contamination.
    2. Allow the disinfectant to sit on the equipment for the recommended time as per the disinfectant manufacturer’s guidelines.
    3. Rinse thoroughly with clean water after the required contact time.
  5. Dry the Equipment

    1. Wipe down the equipment with clean, lint-free cloths to remove excess moisture.
    2. If necessary, use compressed air or fans to speed up the drying process and ensure the equipment is fully dry before reassembly.
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5.3 Post-Cleaning Inspection

After cleaning, the equipment must be inspected to ensure that no residues remain:

  1. Inspect for Residues

    1. Visually inspect the equipment to confirm that there are no residues from the soft gelatin batch left on the equipment.
    2. If necessary, use a wipe or swab sample from critical surfaces and analyze it to check for any residual contamination.
  2. Ensure Proper Reassembly

    1. If the equipment was disassembled during cleaning, ensure that all parts are properly reassembled and functioning correctly before use.
  3. Document the Results

    1. Document all actions taken during the cleaning process, inspection results, and any deviations or issues encountered in the Cleaning Log (Annexure-1).
    2. If any discrepancies are found during the inspection, repeat the cleaning process and document corrective actions taken.
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5.4 Documentation

Ensure that all cleaning activities are 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 equipment between batches No residue found

Annexure-2: Post-Cleaning Inspection Report

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Capsule Filling 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 process steps Improved cleaning procedures QA Head
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