Capsule: SOP for CIP (Clean-in-Place) in Capsule Manufacturing Facilities – V 2.0

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Capsule: SOP for CIP (Clean-in-Place) in Capsule Manufacturing Facilities – V 2.0

Standard Operating Procedure for CIP (Clean-in-Place) in Capsule Manufacturing Facilities

Department Capsule Manufacturing
SOP No. SOP/CM/125/2025
Supersedes SOP/CM/125/2022
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 procedure for Clean-in-Place (CIP) in capsule manufacturing facilities. CIP ensures that all relevant equipment is thoroughly cleaned without disassembly, preventing cross-contamination and ensuring compliance with Good Manufacturing Practices (GMP). This process is essential for maintaining the quality and safety of the capsules produced.

2. Scope

This SOP applies to all manufacturing equipment used in capsule production, including mixers, granulators, hoppers, and conveyors, that require cleaning between batches. It describes the procedures for cleaning these systems using CIP to ensure no contamination remains in the equipment.

3. Responsibilities

  • Production Operators: Responsible for initiating the CIP process, monitoring its progress, and ensuring that all equipment is thoroughly cleaned according to the procedure.
  • Quality Control (QC) Team: Verifies that the CIP process has been carried out effectively and ensures that no residues remain on the equipment.
  • Quality Assurance (QA) Team: Reviews and ensures compliance with GMP during the CIP process and audits CIP logs for completeness and accuracy.
  • Maintenance Team: Ensures that CIP equipment such as pumps, pipes, and tanks are in good working condition and available for use during the cleaning process.
  • Production Supervisor: Oversees the CIP process, ensuring that it is performed as per this SOP and confirms that the equipment is ready for the next production batch.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the CIP procedure is followed. The QA Manager ensures that the process meets GMP standards, and the QC team confirms that the equipment is cleaned properly before the next batch.

5. Procedure

5.1 Preparation for CIP

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

  1. Turn Off the Equipment

    1. Ensure that all capsule manufacturing equipment is turned off and disconnected from the power supply.
    2. Confirm that no materials are left in the equipment or pipes.
  2. Gather CIP Materials

    1. Collect all required CIP materials, including cleaning agents (detergents, disinfectants), water, and PPE (Personal Protective Equipment).
    2. Ensure that the cleaning agents are compatible with the equipment and effective for cleaning.
  3. Check CIP System

    1. Ensure that the CIP system (pumps, pipes, tanks) is functional and free of any obstructions.
    2. Check that the system is capable of circulating cleaning agents effectively through the equipment.
  4. Prepare CIP Log

    1. Prepare the CIP Log (Annexure-1) to document the entire process, including times, operator details, and any deviations from the standard procedure.

5.2 Pre-CIP Cleaning

Follow these steps before starting the CIP process:

  1. Initial Rinse

    1. Rinse the equipment with warm water to remove any visible residues or powders from the previous batch.
    2. Ensure that all surfaces of the equipment, including pipes, tanks, and mixers, are thoroughly rinsed.
  2. Drain the Equipment

    1. Drain any residual water from the equipment to ensure that the cleaning agent will not be diluted.

5.3 CIP Process

Follow these steps to initiate the CIP process:

  1. Circulate Cleaning Solution

    1. Start the CIP system and circulate the cleaning agent through the equipment for a specified time, ensuring that all surfaces are in contact with the solution.
    2. Monitor the flow rate and temperature of the cleaning solution to ensure they are within the recommended range.
  2. Disinfection (If Required)

    1. If necessary, add a disinfectant to the cleaning solution and circulate it through the equipment to eliminate any microbial contamination.
    2. Follow the manufacturer’s instructions for proper dilution and application of disinfectants.
  3. Flush with Water

    1. After the cleaning solution has been circulated, flush the equipment with clean water to remove any remaining cleaning agents and contaminants.
    2. Ensure that all parts of the equipment are rinsed thoroughly.
  4. Inspect for Residual Contamination

    1. Inspect the equipment to ensure that no residues remain on the surfaces. If any contamination is observed, repeat the cleaning process.
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5.4 Drying the Equipment

After cleaning, proceed with drying the equipment:

  1. Dry the Equipment

    1. Use clean, dry, lint-free cloths to wipe down the equipment surfaces. If needed, allow the equipment to air dry in a clean environment.
    2. If applicable, use drying fans or compressed air to speed up the drying process.

5.5 Post-CIP Inspection

Once the CIP process is complete, perform the following checks:

  1. Inspect for Residual Contamination

    1. Ensure that the equipment is completely dry and free from any residual cleaning agents, dust, or debris.
    2. If any residues are found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all parts of the equipment have been correctly reassembled, and all valves, seals, and pipes are secure.
  3. Test Run

    1. Conduct a test run of the equipment to ensure that it is functioning properly and is free from any contamination before the next batch.
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5.6 Documentation

Document all actions for traceability and compliance:

  1. Complete CIP Log

    1. Record all cleaning actions, including operator details, cleaning times, equipment ID, and any deviations from the standard procedure in the CIP 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. CIP 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: CIP Log

Batch ID CIP Date Operator CIP Action Comments
Batch 001 02/02/2025 John Doe Completed CIP for 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 Checked and calibrated CIP system 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 CIP steps and added inspection stages Improved process accuracy QA Head
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