SOP Guide for Pharma

Capsule: SOP for Handling Capsule Variability in High-Speed Machines – V 2.0

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Capsule: SOP for Handling Capsule Variability in High-Speed Machines – V 2.0

Standard Operating Procedure for Handling Capsule Variability in High-Speed Machines

Department Capsule Manufacturing
SOP No. SOP/CM/109/2025
Supersedes SOP/CM/109/2022
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 handling capsule variability in high-speed machines during the encapsulation process. Variability in capsule weight, fill volume, or sealing integrity can occur at high production speeds. This SOP outlines how to identify, mitigate, and control such variability to ensure consistent product quality.

2. Scope

This SOP applies to all high-speed capsule filling machines used in the manufacturing process. It covers the identification, monitoring, and correction of variability in capsule characteristics such as weight, fill volume, and sealing quality.

3. Responsibilities

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4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that all operators follow this SOP for monitoring and controlling capsule variability. The Maintenance Manager is responsible for ensuring that the equipment is functioning correctly. The QA Manager ensures that all deviations are addressed according to company policies and regulatory standards.

5. Procedure

5.1 Identifying Capsule Variability

Capsule variability is identified through regular inspections during production. The following steps must be followed:

  1. Monitor Capsule Weight
    1. Weigh random samples of capsules at regular intervals during production. Ensure that the capsules meet the weight specifications.
    2. If the weight of the sample is outside the acceptable range, investigate the possible cause and take corrective action.
  2. Monitor Capsule Fill Volume
    1. Inspect the fill volume of randomly selected capsules. Use appropriate equipment (e.g., automated volume measurement tools) to ensure consistency in fill volume.
    2. Adjust the filling system if the fill volume deviates from the target specification.
  3. Monitor Capsule Sealing
    1. Inspect capsule sealing quality by visually checking for cracks, leaks, or incomplete seals.
    2. If sealing variability is observed, check the machine for malfunctions such as pressure inconsistencies or improper sealing temperature.

5.2 Correcting Capsule Variability

If variability is detected, take the following corrective actions:

  1. Adjust Machine Settings
    1. If capsule weight or fill volume is inconsistent, adjust the machine settings such as filling volume, powder flow rate, or capsule alignment.
    2. For sealing issues, check the machine’s temperature and pressure settings, and make adjustments to achieve consistent sealing quality.
  2. Check and Replace Consumables
    1. Inspect the capsule filling material, such as powders or liquids, for consistency. If inconsistencies are found, replace or recondition the material before continuing production.
    2. Inspect sealing equipment, including sealing bands and gaskets, for wear. Replace any worn-out components to restore proper function.
  3. Perform Equipment Maintenance
    1. If variability persists despite adjustments, schedule a maintenance check. Inspect critical components, including the filler, seals, and capsule transport system, for malfunction or wear.
    2. Perform cleaning and calibration of the equipment if necessary.
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5.3 Monitoring and Documentation

Once corrective actions are taken, it is important to document and monitor the effectiveness of the changes:

  1. Record Variability Data
    1. Record the details of the variability event, corrective actions taken, and the results of the follow-up tests in the Variability Log (Annexure-1).
  2. Re-sample and Re-test
    1. After making corrections, re-sample and re-test the capsules to ensure that the variability has been addressed. Continue monitoring at regular intervals to ensure consistency in product quality.

5.4 Resuming Production

After ensuring that capsule variability has been corrected, production can resume:

  1. QA Review
    1. Have the QA team review all records, including machine settings, testing results, and corrective actions. Verify that the final product meets the required specifications.
  2. Production Resumption
    1. If everything meets the required standards, resume capsule production and continue to monitor the machine’s performance closely during the next few production runs.
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6. Abbreviations

7. Documents

  1. Variability Log (Annexure-1)
  2. Capsule Weight and Fill Volume Log (Annexure-2)
  3. Deviation Log (Annexure-3)
  4. Maintenance 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: Variability Log

Event ID Batch ID Type of Variability Corrective Action Operator Approval Status
VAR-001 Batch 001 Weight Inconsistency Adjusted fill volume John Doe Approved

Annexure-2: Capsule Weight and Fill Volume Log

Sample ID Capsule Weight (mg) Fill Volume (mL) Pass/Fail Operator
Sample 001 500 1.2 Pass Jane Smith

Annexure-3: Deviation Log

Deviation ID Batch ID Description Corrective Action Operator Approval Status
DEV-001 Batch 001 Irregular capsule weight Recalibrated the machine John Doe Approved

Annexure-4: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Filling Machine 001 02/02/2025 Recalibrated filling system Jane Smith 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 troubleshooting and corrective actions Improved accuracy and reduced errors QA Head
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