Capsule: SOP for Handling Capsule Fines During Manufacturing – V 2.0

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Capsule: SOP for Handling Capsule Fines During Manufacturing – V 2.0

Standard Operating Procedure for Handling Capsule Fines During Manufacturing

Department Capsule Manufacturing
SOP No. SOP/CM/073/2025
Supersedes SOP/CM/073/2022
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 fines generated during manufacturing. Proper handling and disposal of capsule fines are essential to maintain product quality, prevent cross-contamination, and comply with regulatory requirements.

2. Scope

This SOP applies to all capsule production processes where capsule fines may be generated, including during encapsulation, handling, and packaging. It covers the collection, segregation, recycling, and disposal of capsule fines.

3. Responsibilities

  • Manufacturing Team: Responsible for identifying, collecting, and segregating capsule fines during the manufacturing process. Ensure that fines are handled according to this SOP and properly recorded in the batch production record.
  • Quality Control (QC) Team: Responsible for inspecting the quality of the capsule fines and ensuring they meet the required standards for recycling or disposal. Ensure that fines do not affect the overall product quality.
  • Quality Assurance (QA) Team: Ensures compliance with this SOP and reviews records of capsule fines handling to maintain compliance with GMP and regulatory guidelines.
  • Environmental and Safety Team: Responsible for ensuring that all disposal or recycling activities related to capsule fines comply with environmental and safety regulations.

4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the procedures for handling capsule fines are followed properly. The QA Manager is responsible for ensuring compliance with regulatory and quality standards regarding the handling of capsule fines.

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5. Procedure

5.1 Identification and Collection of Capsule Fines

During the manufacturing process, capsule fines can be generated at various stages. The following steps should be followed to ensure proper identification and collection:

  1. Identification of Capsule Fines

    1. Capsule fines are typically generated during the encapsulation process, when capsules are broken or damaged. Fines may also arise from mechanical handling during transportation or packaging.
    2. Capsule fines should be identified as small particles or broken capsule parts that do not meet the required specifications for the finished product.
  2. Collection of Capsule Fines

    1. Collect the capsule fines immediately after they are identified. Use dedicated containers or bags to segregate the fines from the rest of the capsule production batch.
    2. Ensure that all collected capsule fines are labeled with relevant details such as batch number, date, and reason for collection (e.g., mechanical breakdown, weight discrepancies).
  3. Segregation

    1. Ensure that capsule fines are segregated from intact capsules to prevent cross-contamination. Fines should be stored in a designated area or container separate from other capsules until they are disposed of or recycled.

5.2 Inspection and Quality Control of Capsule Fines

Once capsule fines are collected, they should undergo inspection and quality control tests:

  1. Visual Inspection

    1. Inspect the capsule fines visually to check for any contamination, foreign materials, or impurities. Only fines that are free from contamination should be considered for recycling or disposal.
  2. Moisture Content and Stability Test

    1. If capsule fines are intended for recycling or reuse in the manufacturing process, conduct moisture content testing and stability testing to ensure they meet the required specifications.
  3. Weight and Composition Analysis

    1. Analyze the weight and composition of the fines to ensure that they are consistent with the intended formulation. If the fines deviate significantly from the original formulation, they should not be reused.
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5.3 Recycling of Capsule Fines

If capsule fines meet the quality requirements, they may be recycled into the manufacturing process:

  1. Recycling Process

    1. Recycling of capsule fines involves reintroducing them into the capsule filling process. Ensure that the fines are reprocessed to meet the required specifications, including size, weight, and flowability.
  2. Reprocessing Procedure

    1. If reprocessing is needed, mix the fines with fresh excipients and API to achieve the desired granulation or fill material characteristics. Conduct appropriate quality control tests to verify the quality of the recycled material.
  3. Record Recycled Material

    1. Document all instances where capsule fines are recycled, including the batch numbers, reprocessing details, and test results. This ensures traceability and compliance with GMP.

5.4 Disposal of Capsule Fines

If capsule fines are not suitable for recycling, they must be disposed of in an environmentally responsible manner:

  1. Disposal Method

    1. Dispose of capsule fines in accordance with local environmental regulations. Use approved waste disposal methods, including incineration or landfill, if applicable.
  2. Waste Documentation

    1. Document the disposal of capsule fines in the waste disposal log. Include details such as batch number, quantity of fines, disposal method, and the date of disposal.

5.5 Documentation and Record-Keeping

Ensure proper documentation of all capsule fines handling activities:

  1. Batch Production Record (BPR)

    1. Document the handling, segregation, and quality control of capsule fines in the batch production record (BPR). Include the details of the fines collected, reasons for generation, and the final disposition.
  2. Deviation Report

    1. Record any deviations during the manufacturing process that led to the generation of capsule fines in a deviation report. Include corrective actions and preventive measures taken to avoid future occurrences.
  3. Recycling/Disposal Log

    1. Maintain a log of all recycled or disposed capsule fines, including the batch number, amount, and method of recycling or disposal. This ensures traceability for auditing purposes.
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6. Abbreviations

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

7. Documents

  1. Capsule Fines Collection Log (Annexure-1)
  2. Deviation Report (Annexure-2)
  3. Recycling/Disposal Log (Annexure-3)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • International Conference on Harmonization (ICH) Guidelines for Pharmaceutical 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 Fines Collection Log

Batch ID Capsule Type Fines Collected (g) Date Collected Reason for Fines Operator Name
Batch 001 Hard Gelatin 50g 01/02/2025 Breakage during encapsulation John Doe

Annexure-2: Deviation Report

Deviation ID Description Corrective Action Taken Operator Name
DEV-001 Excessive capsule breakage Adjusted capsule filling machine settings John Doe

Annexure-3: Recycling/Disposal Log

Batch ID Quantity of Fines Method of Disposal Disposal Date
Batch 001 50g Incineration 02/02/2025

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 handling and disposal process Standardization QA Head
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