to prevent contamination.

Maintenance Team: Responsible for inspecting dust collection systems and ensuring that all equipment is functioning properly after cleaning.

Quality Control (QC) Team: Ensures that the cleaning process meets GMP standards and verifies that no residues are left in the dust collection system after cleaning.

Quality Assurance (QA) Team: Reviews cleaning documentation and ensures that cleaning activities are performed in compliance with regulatory requirements.

Production Supervisor: Oversees the cleaning of the dust collection systems and ensures that the process is carried out in a timely manner and according to the SOP.

4. Accountability

The Capsule Manufacturing Supervisor is responsible for ensuring that dust collection systems are cleaned in accordance with this SOP. The QA Manager ensures that cleaning activities are compliant with GMP standards and reviews all cleaning records.

5. Procedure

5.1 Preparation for Cleaning Dust Collection Systems

Before starting the cleaning process, the following steps must be completed:

1. Turn Off Equipment and Isolate the System
   1. Ensure that the dust collection system is turned off and isolated from any active processes to prevent contamination during cleaning.
   2. Shut down any equipment connected to the system to avoid accidental operation during cleaning.
2. Gather Cleaning Materials
   1. Collect necessary cleaning agents, such as non-abrasive cleaners, disinfectants, and brushes.
   2. Ensure that cleaning materials are safe for use on the dust collection system components and will not cause damage or degradation.
3. Inspect the Dust Collection System
   1. Inspect the dust collection system for any visible debris, dust build-up, or damage that needs special attention during the cleaning process.
   2. Note any areas that require additional maintenance or repairs and document them in the Equipment Maintenance Log (Annexure-1).

5.2 Cleaning Process for Dust Collection Systems

Follow these steps to clean the dust collection system effectively:

1. Remove Dust and Debris
   1. Using a soft brush or vacuum cleaner, carefully remove any dust and debris from the internal and external surfaces of the dust collection system, including ducts and filters.
   2. Be cautious not to damage delicate components while cleaning the filters and ducts.
2. Apply Cleaning Solution
   1. Apply an appropriate cleaning solution to the dust collection components that require cleaning. This may include wiping down the filters, ducts, and collection bins.
   2. Use non-abrasive cleaning materials to avoid damaging the system’s components.
3. Rinse and Clean Filters
   1. If the filters are removable, rinse them with clean water to remove any remaining dust or cleaning agents. Ensure that all residues are removed from the filters.
   2. If the filters cannot be removed, clean them in place by using a vacuum or air compressor to remove any dust or debris.
4. Clean and Disinfect Collection Bins
   1. Clean the collection bins by removing any accumulated dust and wiping them down with a clean cloth and suitable disinfectant.
   2. Ensure that no cleaning solution residue is left in the bins, as this could contaminate future products.
5. Dry the System
   1. Use clean, lint-free cloths to wipe down all parts of the dust collection system and remove any excess moisture.
   2. If required, use compressed air or drying equipment to ensure all parts are completely dry before reassembly.

5.3 Post-Cleaning Inspection

After cleaning, inspect the dust collection system to ensure it is free from residues and ready for use:

1. Visual Inspection
   1. Visually inspect all components of the dust collection system, including filters, ducts, and collection bins, to ensure they are clean and free from any residues or cleaning agents.
   2. Check that the system is properly reassembled and that no components are missing or damaged.
2. Functionality Check
   1. Test the dust collection system to ensure it is functioning properly. This includes checking airflow and ensuring that all components are operating as expected.
3. Document Cleaning Results
   1. Record the cleaning process in the Cleaning Log (Annexure-2), including the date, operator details, and any issues encountered during cleaning.

5.4 Documentation

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

1. Complete Cleaning Log
   1. Document all cleaning actions, including the date, operator name, and any issues found during cleaning, in the Cleaning Log (Annexure-2).
2. Post-Cleaning Inspection Report
   1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-3), including the functional test results and any corrective actions taken.

6. Abbreviations

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

7. Documents

1. Cleaning Log (Annexure-2)
2. Post-Cleaning Inspection Report (Annexure-3)

8. References

• USP <1163 You said: Continue ChatGPT said: Here is the continuation of SOP 142: SOP for Cleaning Dust Collection Systems in Capsule Production: html Copy
  

  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-2: Cleaning Log

  Batch ID	Cleaning Date	Operator	Cleaning Action	Comments
  Batch 001	02/02/2025	John Doe	Completed cleaning of dust collection system	No issues found

  Annexure-3: Post-Cleaning Inspection Report

  System ID	Inspection Date	Inspection Results	Operator	Next Maintenance Due
  Dust Collection System 001	02/02/2025	Clean and ready for use	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 cleaning process steps	Improved cleaning methodology	QA Head