Capsule: SOP for Disposal of Cleaning Residues from Capsule Machines – V 2.0

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Capsule: SOP for Disposal of Cleaning Residues from Capsule Machines – V 2.0

Standard Operating Procedure for Disposal of Cleaning Residues from Capsule Machines

Department Capsule Manufacturing
SOP No. SOP/CM/139/2025
Supersedes SOP/CM/139/2022
Page No. Page 1 of 5
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 process for the proper disposal of cleaning residues from capsule manufacturing machines. Proper disposal of residues is critical to avoid contamination, ensure environmental compliance, and maintain workplace safety. This SOP ensures that all residues from cleaning operations, including dust, powders, cleaning agents, and other by-products, are disposed of in accordance with regulatory and safety guidelines.

2. Scope

This SOP applies to the disposal of all cleaning residues from capsule manufacturing equipment, including but not limited to capsule filling machines, blenders, sieves, and mixers. It covers the safe collection, handling, and disposal procedures for cleaning residues after cleaning operations.

3. Responsibilities

  • Production Operators: Responsible for collecting cleaning residues from capsule manufacturing machines and ensuring they are disposed of according to the SOP.
  • Cleaning Staff: Responsible for assisting with the disposal of cleaning residues and ensuring compliance with the disposal procedures.
  • Waste Management Team: Responsible for overseeing the collection and disposal of cleaning residues, ensuring that waste disposal is carried out according to regulatory requirements.
  • Quality Control (QC) Team: Ensures that cleaning residues are properly disposed of and confirms that no residues remain in equipment or are disposed of improperly.
  • Quality Assurance (QA) Team: Reviews and approves the procedures for cleaning residue disposal to ensure compliance with GMP and safety regulations.
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4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that cleaning residues are disposed of properly according to this SOP. The Waste Management Officer is accountable for overseeing the safe disposal of residues and ensuring that all applicable environmental and safety regulations are followed.

5. Procedure

5.1 Collection of Cleaning Residues

Before disposing of cleaning residues, complete the following steps:

  1. Ensure Equipment is Cleaned First

    1. Confirm that all equipment has been cleaned thoroughly according to the SOP for cleaning, and no residues remain in the equipment.
    2. Check the equipment visually to ensure that no product or cleaning agents remain inside the machines.
  2. Collect Residues

    1. Collect all cleaning residues, including dust, powder, detergent, and other waste materials, in a designated container for disposal.
    2. Ensure that the container is properly sealed to prevent contamination during transportation to the disposal area.
  3. Record Collection Details

    1. Document the collection of cleaning residues in the Waste Collection Log (Annexure-1), noting the type of residue, equipment cleaned, and the date of collection.

5.2 Disposal of Cleaning Residues

Follow the steps below to dispose of cleaning residues properly:

  1. Segregate Waste

    1. Ensure that all cleaning residues are segregated based on their type, such as dust, cleaning agents, and product residues.
    2. Use separate containers for hazardous and non-hazardous residues to avoid contamination and ensure compliance with safety regulations.
  2. Transport Residues to Disposal Area

    1. Transport the collected residues to the designated disposal area using appropriate waste management procedures.
    2. Ensure that all containers are securely sealed and labeled with the content type and disposal instructions.
  3. Disposal by Authorized Personnel

    1. Only authorized personnel should handle and dispose of cleaning residues. The Waste Management Team is responsible for managing the disposal process.
    2. Ensure that all cleaning residues are disposed of following local environmental and regulatory guidelines, such as through licensed waste disposal companies or designated disposal facilities.
  4. Document Disposal Process

    1. Record all disposal actions, including the date, type of residues, disposal method, and personnel involved in the process, in the Waste Disposal Log (Annexure-2).
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5.3 Post-Disposal Inspection

After disposal, inspect the disposal area to ensure that no residues remain and that proper disposal was carried out:

  1. Inspect Disposal Area

    1. Inspect the disposal area to ensure that all waste containers are properly sealed and no residues remain in the area.
    2. If any residues are found, take immediate corrective actions to clean the area and document the findings in the Waste Disposal Log (Annexure-2).
  2. Verify Documentation

    1. Ensure that all cleaning residue disposal actions have been documented accurately, including signatures from authorized personnel and any issues encountered during disposal.

5.4 Documentation

Ensure all cleaning residue disposal activities are properly documented for traceability and compliance:

  1. Complete Waste Collection Log

    1. Document all waste collection details, including the type of cleaning residue, equipment cleaned, and operator details in the Waste Collection Log (Annexure-1).
  2. Complete Waste Disposal Log

    1. Record all waste disposal actions, including the date, method of disposal, and personnel involved, in the Waste Disposal Log (Annexure-2).
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6. Abbreviations

  • SOP: Standard Operating Procedure
  • GMP: Good Manufacturing Practice
  • QC: Quality Control
  • QA: Quality Assurance
  • PPE: Personal Protective Equipment

7. Documents

  1. Waste Collection Log (Annexure-1)
  2. Waste Disposal Log (Annexure-2)

8. References

  • USP <1163> – Pharmaceutical Dosage Forms: Capsules
  • FDA Guidelines for Capsule Manufacturing
  • Good Manufacturing Practice (GMP) Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Waste Collection Log

Batch ID Residue Type Collection Date Operator Comments
Batch 001 Cleaning Residues 02/02/2025 John Doe No contamination

Annexure-2: Waste Disposal Log

Residue Type Disposal Date Disposal Method Authorized Personnel Comments
Cleaning Residues 02/02/2025 Incineration Jane Smith No issues

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 disposal steps Clarification of waste disposal procedures QA Head
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