Capsule: SOP for Cleaning Gelatin Feeders in Capsule Manufacturing – V 2.0

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Capsule: SOP for Cleaning Gelatin Feeders in Capsule Manufacturing – V 2.0

Standard Operating Procedure for Cleaning Gelatin Feeders in Capsule Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/119/2025
Supersedes SOP/CM/119/2022
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 gelatin feeders used in capsule manufacturing. The cleaning ensures that no cross-contamination occurs between batches and that the gelatin is processed without any residues, maintaining high quality and compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all gelatin feeders used in the production of hard gelatin capsules. It details the cleaning process to be followed after each production batch to ensure the feeders are free from any gelatin residue or contaminants before the next use.

3. Responsibilities

  • Production Operators: Responsible for disassembling the gelatin feeders, cleaning them thoroughly, and reassembling them after cleaning as per this SOP.
  • Quality Control (QC) Team: Ensures that the cleaning process has been carried out effectively and verifies that there are no residues or contaminants left in the feeders.
  • Quality Assurance (QA) Team: Verifies that the cleaning process complies with GMP standards and ensures proper documentation is completed.
  • Maintenance Team: Ensures that any mechanical issues with the gelatin feeders are addressed during the cleaning process and that the equipment is reassembled correctly.
  • Production Supervisor: Oversees the cleaning process, ensures adherence to this SOP, and confirms that the gelatin feeders are ready for the next production batch.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that the gelatin feeders are cleaned as per this SOP. The QA Manager ensures that the cleaning process complies with GMP and verifies that the documentation is completed accurately.

5. Procedure

5.1 Preparation for Cleaning

Before beginning the cleaning process, ensure the following steps:

  1. Turn Off the Equipment

    1. Ensure the gelatin feeder is powered off, and the power supply is disconnected to avoid electrical hazards during cleaning.
  2. Gather Cleaning Materials

    1. Collect the necessary cleaning materials, including warm water, approved cleaning agents, soft brushes, lint-free cloths, and any required PPE (Personal Protective Equipment) for safety.
    2. Ensure that cleaning agents are compatible with the gelatin feeder materials and non-corrosive.
  3. Prepare Cleaning Log

    1. Prepare the Cleaning Log (Annexure-1) to record all cleaning actions, operator details, time, and any deviations or observations.

5.2 Disassembling the Gelatin Feeder

If necessary, disassemble the gelatin feeder components for thorough cleaning:

  1. Remove Components for Cleaning

    1. Carefully disassemble the gelatin feeder parts, including trays, nozzles, and agitators, to ensure proper cleaning.
    2. Take care not to damage any sensitive components.
  2. Label Disassembled Parts

    1. Label each disassembled component to ensure proper reassembly after cleaning.
  3. Place Parts in Cleaning Stations

    1. Place all disassembled parts in designated cleaning stations to facilitate effective cleaning.

5.3 Cleaning Process

Follow these steps to clean the gelatin feeder:

  1. Initial Rinse

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

    1. Apply a mild, non-abrasive cleaning agent to all surfaces of the gelatin feeder and components. Use soft brushes to scrub surfaces and remove any remaining residues.
  3. Rinse with Warm Water

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

    1. If necessary, apply an appropriate disinfectant to the parts of the feeder to prevent microbial contamination. Follow the manufacturer’s guidelines for proper use.
  5. Final Rinse

    1. Perform a final rinse with clean warm water to ensure that all disinfectant or cleaning agents are removed.
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5.4 Drying and Reassembly

After cleaning, proceed with drying and reassembly:

  1. Dry the Components

    1. Dry all cleaned components with a clean, dry, lint-free cloth. If necessary, allow components to air dry completely.
  2. Reassemble the Equipment

    1. After the components are completely dry, carefully reassemble the gelatin feeder, ensuring that all parts are installed correctly and securely.

5.5 Post-Cleaning Inspection

Once the cleaning and reassembly are complete, perform the following checks:

  1. Inspect for Residual Contamination

    1. Visually inspect the gelatin feeder for any remaining cleaning agents, residues, or contamination. If contamination is found, repeat the cleaning process.
  2. Check for Proper Reassembly

    1. Ensure that all components are correctly reassembled and securely fastened.
  3. Run Test Batch

    1. Run a small test batch of gelatin to ensure that the feeder is working properly and that there is no contamination from previous batches.
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5.6 Documentation

Document the entire cleaning process for compliance and traceability:

  1. Complete Cleaning Log

    1. Record all cleaning actions, including 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 Disassembled and cleaned gelatin feeder components No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Gelatin Feeder 001 02/02/2025 No defects found, machine fully operational Jane Smith 02/02/2026

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Gelatin Feeder 001 02/02/2025 Cleaned and calibrated gelatin material flow 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 cleaning process and added post-cleaning inspection steps Improved cleaning process accuracy QA Head
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