Capsule: SOP for Operating Capsule Filling Machines – V 2.0

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Capsule: SOP for Operating Capsule Filling Machines – V 2.0

Standard Operating Procedure for Operating Capsule Filling Machines

Department Capsule Manufacturing
SOP No. SOP/CM/054/2025
Supersedes SOP/CM/054/2022
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 standard operating procedures for the operation of capsule filling machines. This procedure ensures that the capsule filling process is efficient, accurate, and complies with all regulatory and quality standards.

2. Scope

This SOP applies to all operators and personnel involved in the operation of capsule filling machines for the manufacturing of capsules. It covers machine setup, operation, and troubleshooting processes for filling hard gelatin capsules.

3. Responsibilities

  • Machine Operators: Responsible for operating the capsule filling machine, ensuring correct setup, and ensuring the filling process is carried out as per this SOP.
  • Maintenance Team: Responsible for performing routine maintenance and troubleshooting of capsule filling machines to ensure proper functioning.
  • Quality Control (QC) Team: Responsible for verifying that the capsules meet weight uniformity, fill accuracy, and other specifications as part of the quality assurance process.
  • Quality Assurance (QA) Team: Ensures that all filling operations follow GMP and regulatory guidelines, and reviews records for compliance with this SOP.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring the proper operation of capsule filling machines. The QA Manager is responsible for ensuring that all procedures comply with GMP and regulatory requirements.

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5. Procedure

5.1 Pre-Operation Setup

Before starting the capsule filling machine, ensure the following steps are completed:

  1. Machine Inspection

    1. Inspect the capsule filling machine to ensure it is clean and free of any debris or previous batch remnants.
    2. Ensure that all machine components, such as the hopper, dosing unit, and capsule guides, are properly aligned and functional.
  2. Preparation of Materials

    1. Ensure that the capsules (empty shells) and the fill material (powders, granules, liquids) are ready for use.
    2. Weigh the fill material to ensure it meets the required batch weight specifications for capsule filling.
  3. Loading Capsules

    1. Load the empty capsules into the hopper of the filling machine. Ensure the capsules are properly aligned to avoid jamming or misplacement during the filling process.
  4. Machine Calibration

    1. Calibrate the machine to ensure accurate capsule filling. Adjust the settings for capsule size, fill weight, and fill speed according to the formulation requirements.

5.2 Operation of the Capsule Filling Machine

Once the machine setup is complete, follow the steps below to operate the capsule filling machine:

  1. Starting the Machine

    1. Start the machine according to the manufacturer’s instructions. Monitor the initial operation to ensure that the capsules are filling smoothly.
  2. Filling Process

    1. Monitor the filling process continuously to ensure that the capsules are filled evenly. Check the consistency of the fill material and ensure that there are no blockages or deviations in the capsule filling process.
  3. Capsule Ejection

    1. Once filled, the capsules will be ejected into a designated container. Ensure that the filled capsules are free of defects and are properly sealed.
  4. Adjustments During Operation

    1. If any issues such as overfilling or underfilling occur, adjust the settings of the machine. Ensure that the fill weight is uniform and meets the required specifications.
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5.3 Quality Control and Monitoring

During the capsule filling operation, continuous quality control is essential:

  1. Weight Check

    1. Regularly check the weight of the filled capsules to ensure uniformity. Take samples at set intervals and check the weight against the target specification.
  2. Visual Inspection

    1. Visually inspect the filled capsules for defects, such as broken or poorly sealed capsules. Reject any capsules that do not meet the required quality standards.
  3. Filling Accuracy

    1. Monitor the filling accuracy, ensuring that the capsules are filled with the correct amount of fill material as per the batch record. Perform fill weight tests at regular intervals.

5.4 Post-Operation Cleaning and Maintenance

After completing the capsule filling process, perform the following steps:

  1. Cleaning the Machine

    1. Turn off the machine and clean all parts that came into contact with the fill material and capsules. Use appropriate cleaning agents and ensure that all residues are removed.
    2. Ensure that the machine is properly dried before storing it or starting the next batch.
  2. Maintenance Check

    1. Perform a quick maintenance check to ensure that no parts of the machine are worn out or require replacement. Lubricate the machine if necessary according to the manufacturer’s guidelines.

5.5 Documentation and Record-Keeping

Ensure proper documentation and record-keeping for the capsule filling process:

  1. Batch Records

    1. Document all aspects of the filling process, including the machine settings, batch number, fill material details, and operator information.
  2. Quality Control Records

    1. Maintain records of all quality control checks, including capsule weight checks, visual inspections, and any deviations observed during the operation.
  3. Deviation Reports

    1. If any deviations or issues are identified during the filling process, document them in a deviation report and outline corrective actions taken.
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • API: Active Pharmaceutical Ingredient
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance

7. Documents

  1. Capsule Filling Machine Batch Record (Annexure-1)
  2. Quality Control Test Report (Annexure-2)
  3. Deviation Report (Annexure-3)

8. References

  • USP <616> – Capsule Filling Machines
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical Product Manufacturing

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Capsule Filling Machine Batch Record

Batch ID Machine ID Fill Material Capsule Size Operator Name Filling Speed
Batch 001 Machine 15 Vitamin C Size 00 John Doe 50 rpm

Annexure-2: Quality Control Test Report

Test Type Result Specification Remarks
Weight Check 100 mg 95-105 mg Pass

Annexure-3: Deviation Report

Deviation ID Description Corrective Action Action Taken By
DR-001 Underfilled Capsules Increased fill weight Manufacturing Supervisor

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 fill material and weight check procedures Standardization QA Head
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