SOP Guide for Pharma

Capsule: SOP for Using Metal Detectors in Capsule Manufacturing – V 2.0

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Capsule: SOP for Using Metal Detectors in Capsule Manufacturing – V 2.0

Standard Operating Procedure for Using Metal Detectors in Capsule Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/085/2025
Supersedes SOP/CM/085/2022
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 using metal detectors during capsule manufacturing. The goal is to ensure that any metallic contamination in the capsules is detected and removed before the product proceeds to the packaging stage. This is crucial for ensuring product safety and compliance with quality control standards.

2. Scope

This SOP applies to all capsule manufacturing batches where metal detectors are used to check for metallic contamination in capsules. It covers the setup, calibration, operation, and maintenance of metal detectors in capsule manufacturing, as well as handling procedures for any detected contamination.

3. Responsibilities

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that metal detectors are set up, calibrated, and operated correctly according to this SOP. The QA Manager is responsible for reviewing and approving any deviations from the SOP and ensuring regulatory compliance.

5. Procedure

5.1 Setup and Calibration of Metal Detectors

Before starting production, ensure that the metal detector is correctly set up and calibrated:

  1. Check Equipment Condition
    1. Inspect the metal detector for any signs of damage or malfunction. Ensure that all parts, such as belts, sensors, and detection coils, are in good condition.
    2. Ensure that the metal detector’s power supply and control systems are operational.
  2. Calibrate the Metal Detector
    1. Perform calibration using known metal test pieces (typically ferrous, non-ferrous, and stainless steel) to ensure the detector is sensitive to the appropriate metal types.
    2. Set the sensitivity level based on the product and type of metal contamination that may be encountered. Calibration should be done in accordance with the equipment manufacturer’s instructions.
  3. Set the Detection Parameters
    1. Set the detection parameters, including sensitivity and reject thresholds, based on the product and batch requirements. The sensitivity should be set to detect metallic contamination without causing false rejections.
  4. Verify Calibration
    1. Run a test batch of capsules through the metal detector to verify that it detects metal pieces as expected. Record the test results and make adjustments if necessary.
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5.2 Operating the Metal Detector During Production

Once the metal detector is set up, follow these steps to operate it during capsule manufacturing:

  1. Feed Capsules through Metal Detector
    1. Ensure that capsules are fed properly into the metal detection system. They should be spaced evenly to avoid overlapping, which could interfere with the detection process.
    2. Monitor the flow of capsules to ensure that they are being processed at the correct speed and are properly positioned in the detection area.
  2. Monitor Metal Detection Process
    1. Continuously monitor the metal detector during production to ensure it is operating at optimal levels. Look for any alerts or system errors that could indicate a malfunction or calibration issue.
    2. Check the detection logs for consistency and ensure that no deviations are occurring.
  3. Respond to Alerts
    1. If the metal detector detects contamination, it will trigger an alert or reject the capsule. Respond immediately by halting the production line and investigating the cause of the contamination.
    2. Document the rejection, noting the type of metal detected, the number of affected capsules, and the corrective actions taken.
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5.3 Handling Detected Contamination

If metallic contamination is detected, take the following steps to manage the situation:

  1. Reject Contaminated Capsules
    1. Remove any affected capsules from the production line immediately. These capsules should be placed in a designated rejection bin labeled “Metal Contamination.” Ensure that contaminated capsules are not mixed with good capsules.
  2. Investigate the Source of Contamination
    1. Investigate the root cause of the contamination. Check the equipment for any sources of metal contamination, such as faulty machine parts or broken components. Review the incoming raw materials to ensure they are free from contaminants.
    2. If the contamination is due to equipment malfunction, shut down the machine for maintenance and troubleshooting.
  3. Corrective Actions
    1. Implement corrective actions, such as repairing the equipment, replacing damaged components, or reviewing production processes. Document all actions taken in the deviation log.
  4. Run Test Batches
    1. Run test batches after corrective actions to ensure that the issue has been resolved and that the metal detector is functioning correctly.

5.4 Routine Maintenance and Calibration

Perform regular maintenance and calibration checks to ensure that the metal detector remains in good working order:

  1. Daily Maintenance
    1. Perform a quick inspection of the metal detector before and after each production shift to ensure that there are no obvious signs of damage or malfunction.
    2. Clean the metal detector according to the manufacturer’s instructions to prevent buildup of dust or contaminants that could affect its sensitivity.
  2. Monthly Calibration
    1. Perform a full calibration of the metal detector at least once a month using metal test pieces. Ensure that the detector is still sensitive enough to detect the appropriate size of metal particles.
  3. Record Calibration Results
    1. Document all calibration results in the equipment maintenance log and review the records periodically to ensure consistency.

5.5 Documentation and Reporting

Ensure that all actions related to metal detection are thoroughly documented:

  1. Document Detection Results
    1. Record the results of each metal detection check in the metal detector log, including any rejected capsules and corrective actions taken.
  2. Report Deviations
    1. If deviations or metal contamination issues occur, document them in the deviation report, including the steps taken to address the problem and prevent recurrence.
  3. Review Logs
    1. Regularly review the metal detection logs to identify any trends or recurring issues. Investigate any patterns of contamination and implement preventive measures.
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6. Abbreviations

7. Documents

  1. Batch Production Record (BPR) (Annexure-1)
  2. Metal Detector Calibration Log (Annexure-2)
  3. Deviation Report (Annexure-3)
  4. Metal Detection Test Log (Annexure-4)

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: Batch Production Record (BPR)

Batch ID Production Date Metal Detected Operator Name Action Taken
Batch 001 01/02/2025 None John Doe Approved

Annexure-2: Metal Detector Calibration Log

Calibration Date Metal Type Test Piece Size Operator Name Calibration Result
01/02/2025 Ferrous 3mm Jane Smith Pass
01/02/2025 Non-Ferrous 3mm Jane Smith Pass

Annexure-3: Deviation Report

Deviation ID Description Corrective Action Taken Operator Name Approval Status
DEV-001 Contaminated Capsule Detected Repaired faulty sealing component, recalibrated metal detector John Doe Approved

Annexure-4: Metal Detection Test Log

Test ID Test Date Metal Type Detected Capsules Affected Action Taken
TEST-001 01/02/2025 Ferrous 10 capsules Rejected, machine reset

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 calibration procedure and log format Standardization QA Head
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