Capsule: SOP for WIP (Wash-in-Place) of Capsule Manufacturing Equipment – V 2.0

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Capsule: SOP for WIP (Wash-in-Place) of Capsule Manufacturing Equipment – V 2.0

Standard Operating Procedure for WIP (Wash-in-Place) of Capsule Manufacturing Equipment

Department Capsule Manufacturing
SOP No. SOP/CM/126/2025
Supersedes SOP/CM/126/2022
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 Wash-in-Place (WIP) cleaning in capsule manufacturing equipment. WIP is used to clean equipment without disassembling it, reducing downtime and the risk of contamination between production batches. This process ensures compliance with Good Manufacturing Practices (GMP) and maintains product quality.

2. Scope

This SOP applies to all equipment used in capsule manufacturing that requires cleaning between production cycles, including mixers, granulators, filling machines, and conveyors. It describes the steps for using WIP cleaning to ensure that no residues or contaminants remain after each batch.

3. Responsibilities

  • Production Operators: Responsible for initiating and monitoring the WIP cleaning process, ensuring that the equipment is cleaned properly after each production cycle.
  • Quality Control (QC) Team: Verifies that the equipment is adequately cleaned and free from contaminants before the next production batch.
  • Quality Assurance (QA) Team: Ensures compliance with GMP during the WIP cleaning process and reviews cleaning logs for completeness and accuracy.
  • Maintenance Team: Ensures that the WIP system is functional and free of any blockages before use.
  • Production Supervisor: Oversees the WIP cleaning process, ensuring adherence to this SOP and verifying that equipment is ready for the next batch.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the WIP process is completed properly and that all equipment is cleaned according to this SOP. The QA Manager is responsible for ensuring compliance with GMP standards during the cleaning process.

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5. Procedure

5.1 Preparation for WIP Cleaning

Before initiating the WIP 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 to avoid any electrical hazards during the cleaning process.
    2. Confirm that there are no capsules or other materials left in the equipment.
  2. Gather WIP Materials

    1. Collect all necessary cleaning agents, including detergents, sanitizers, and water, as well as any PPE (Personal Protective Equipment) required for the process.
    2. Ensure that the cleaning agents are compatible with the equipment and effective at removing residues from previous batches.
  3. Inspect the WIP System

    1. Check the WIP system, including pipes, pumps, and cleaning tanks, to ensure it is functioning correctly and free from obstructions.
  4. Prepare Cleaning Log

    1. Prepare the WIP Cleaning Log (Annexure-1) to record all cleaning activities, operator details, dates, and any deviations or issues encountered during the process.

5.2 WIP Cleaning Process

Follow these steps to perform the WIP cleaning:

  1. Flush the System with Water

    1. Begin by flushing the system with warm water to remove any loose material or residues from the equipment.
    2. Ensure that water flows through all equipment and pipes to remove any visible residues.
  2. Circulate Cleaning Solution

    1. Introduce an approved cleaning solution into the WIP system and circulate it through the equipment for the recommended duration to remove any remaining contaminants.
    2. Ensure that the cleaning solution is in contact with all parts of the equipment, including the internal surfaces and hard-to-reach areas.
  3. Rinse with Clean Water

    1. Once the cleaning solution has circulated for the required time, rinse the equipment thoroughly with clean water to remove any remaining cleaning solution and contaminants.
    2. Ensure that the entire system is properly flushed to avoid contamination in the next production batch.
  4. Disinfection (If Required)

    1. If required, add an appropriate disinfectant to the WIP system and circulate it for the specified time to eliminate any microbial contaminants.
    2. Follow the manufacturer’s instructions for the disinfectant’s use and dilution.
  5. Final Rinse

    1. Perform a final rinse with clean water to remove any disinfectant residues from the system.
    2. Ensure that the system is free from any cleaning agents before it is used again for production.
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5.3 Drying the Equipment

Once the cleaning is complete, follow these steps for drying:

  1. Dry the Equipment

    1. Use clean, dry, lint-free cloths to wipe down any accessible surfaces. If necessary, allow the equipment to air dry in a clean environment to ensure all moisture is removed.
    2. If applicable, use drying fans or compressed air to assist in drying any internal parts.

5.4 Reassembling the Equipment

After drying, reassemble the equipment:

  1. Reassemble the Equipment

    1. Carefully reassemble the equipment, ensuring that all parts are securely fastened and correctly installed.

5.5 Post-WIP Inspection

After the cleaning and reassembly process, perform the following checks:

  1. Inspect for Residual Contamination

    1. Inspect the equipment for any visible cleaning agents, dust, or residues. If contamination is found, repeat the cleaning process.
  2. Check for Proper Reassembly

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

    1. Perform a test run of the equipment to ensure it is functioning properly and is free from contamination before the next production cycle.
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5.6 Documentation

Ensure that all actions are properly documented for traceability and compliance:

  1. Complete WIP Cleaning Log

    1. Record all actions in the WIP Cleaning Log (Annexure-1), including operator details, equipment IDs, and any deviations encountered during the cleaning process.
  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. WIP 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: WIP Cleaning Log

Batch ID CIP Date Operator CIP Action Comments
Batch 001 02/02/2025 John Doe Completed WIP 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 WIP system and replaced hoses 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 WIP process and added inspection steps Improved process accuracy QA Head
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