SOP Guide for Pharma

Capsule: SOP for Conducting Line Clearance Before Starting Capsule Manufacturing – V 2.0

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Capsule: SOP for Conducting Line Clearance Before Starting Capsule Manufacturing – V 2.0

Standard Operating Procedure for Conducting Line Clearance Before Starting Capsule Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/087/2025
Supersedes SOP/CM/087/2022
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 outline the procedure for conducting line clearance before starting the capsule manufacturing process. Proper line clearance ensures that the production line is free from any residual materials, tools, or foreign objects, preventing contamination and ensuring product quality.

2. Scope

This SOP applies to all capsule manufacturing processes. It covers the procedures for cleaning, inspecting, and verifying that the production line is clear of any leftover materials from previous batches or processes before starting a new batch of capsules.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the line clearance procedure is followed before every production run. The QA Manager is responsible for reviewing the line clearance and approving it before manufacturing begins.

5. Procedure

5.1 Preparing for Line Clearance

Before starting the line clearance process, ensure the following preparations are completed:

  1. Notify Relevant Departments
    1. Inform all relevant personnel (Production, QC, and Maintenance) of the upcoming line clearance procedure.
    2. Ensure that all required tools and cleaning materials are available for the procedure.
  2. Shut Down the Previous Production Line
    1. Stop the production equipment from the previous batch and ensure that it is not running.
    2. Ensure that all machinery is safely powered off before starting the line clearance process.
  3. Remove All Materials from the Line
    1. Ensure that all materials, including raw materials, capsules, and packaging materials, are removed from the production line and stored in the designated areas.
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5.2 Conducting Line Clearance

Follow these steps to perform the actual line clearance:

  1. Clean the Equipment
    1. Clean all machines, conveyors, and associated equipment to remove any residual materials from the previous batch.
    2. Ensure that cleaning materials used are appropriate for the equipment and product type.
    3. Document the cleaning procedure in the equipment cleaning log.
  2. Check for Residual Materials
    1. Inspect all equipment and production areas for any residual materials, such as leftover powders, capsules, or packaging waste.
    2. Ensure that the floor, conveyors, and all surfaces are free from contamination.
  3. Inspect Equipment Settings
    1. Ensure that all equipment settings are correct and suitable for the new batch, including adjusting the machine for the correct capsule size and fill weight.

5.3 Verifying Line Clearance

Once the line clearance process is complete, the following verification steps should be carried out:

  1. Visual Inspection
    1. QC personnel should visually inspect the production area and equipment to ensure that the area is clear of any foreign objects or materials.
    2. Check that the equipment has been properly cleaned and is free from contamination.
  2. Confirm Material Removal
    1. Ensure that all raw materials and products from the previous batch have been removed from the production area.
    2. Confirm that no materials have been left in the hoppers, filling stations, or other equipment.
  3. Document Clearance Completion
    1. Document the completion of the line clearance procedure in the line clearance log. Include details such as the time of clearance, personnel involved, and any deviations from the procedure.
    2. Ensure that the log is signed by the responsible operator and supervisor to confirm that the process has been completed successfully.
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5.4 Approving the Line Clearance

Once the line clearance has been completed and verified, the following steps must be taken before manufacturing begins:

  1. Final QA Review
    1. The QA team should review the line clearance documentation and conduct a final check of the production area to ensure compliance with GMP standards.
    2. Ensure that the production area is clear and suitable for starting the next batch of capsules.
  2. Approval of Line Clearance
    1. The QA Manager must sign off on the line clearance procedure, confirming that the production area is ready for the new batch.
    2. After approval, the production process can begin with the new batch of capsules.

5.5 Handling Deviations During Line Clearance

If any deviations from the SOP occur during the line clearance process, take the following steps:

  1. Document the Deviation
    1. Record the deviation in the deviation log, including the nature of the deviation, the root cause, and corrective actions taken.
  2. Implement Corrective Actions
    1. Implement corrective actions to address the cause of the deviation, such as additional cleaning, equipment adjustment, or re-training of personnel.
  3. Review and Approve Corrective Actions
    1. The QA team should review and approve the corrective actions taken before allowing the production process to start.
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5.6 Post-Line Clearance Actions

After the line clearance has been approved, the following actions should be taken:

  1. Prepare for Production
    1. Ensure that all necessary materials, tools, and equipment are available and ready for the start of the new production batch.
    2. Confirm that the production schedule aligns with the available resources and equipment.
  2. Documentation of Line Clearance
    1. Ensure that the line clearance log, deviation log (if applicable), and corrective action reports are completed and filed appropriately for future reference and auditing purposes.

6. Abbreviations

7. Documents

  1. Line Clearance Log (Annexure-1)
  2. Deviation Log (Annexure-2)
  3. Corrective Action Report (CAPA) (Annexure-3)

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Line Clearance Log

Clearance Date Batch Number Operator Name Inspection Results Approval Status
01/02/2025 Batch 001 John Doe Area cleared, no residual materials Approved

Annexure-2: Deviation Log

Deviation ID Description Corrective Action Taken Operator Name
DEV-001 Residue found on equipment Additional cleaning performed Jane Smith

Annexure-3: Corrective Action Report (CAPA)

CAPA ID Root Cause Corrective Action Completion Date Approval Status
CAPA-001 Inadequate cleaning procedure Updated cleaning SOP 02/02/2025 Approved

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 Revised line clearance procedures Standardization QA Head
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