SOP Guide for Pharma

Capsule: SOP for Cleaning Capsule Drying Trays and Racks – V 2.0

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Capsule: SOP for Cleaning Capsule Drying Trays and Racks – V 2.0

Standard Operating Procedure for Cleaning Capsule Drying Trays and Racks

Department Capsule Manufacturing
SOP No. SOP/CM/120/2025
Supersedes SOP/CM/120/2022
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 establish a standard procedure for cleaning capsule drying trays and racks used in the production process. Proper cleaning ensures that no residues from previous batches remain, preventing contamination and ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

This SOP applies to all capsule drying trays and racks used during the drying process of capsules. It covers the cleaning procedure to be followed after each batch to ensure that the trays and racks are free from any contaminants before being used in the next batch.

3. Responsibilities

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4. Accountability

The Capsule Manufacturing Supervisor is accountable for ensuring that the capsule drying trays and racks are cleaned according to this SOP. The QA Manager is responsible for ensuring compliance with GMP and verifying that all cleaning documentation is complete and accurate.

5. Procedure

5.1 Preparation for Cleaning

Before starting the cleaning process, ensure the following:

  1. Turn Off the Equipment
    1. Ensure that the drying trays and racks are turned off, and the power supply (if any) is disconnected to avoid any electrical hazards during cleaning.
  2. Gather Cleaning Materials
    1. Collect necessary cleaning materials, including warm water, non-abrasive cleaning agents, brushes, lint-free cloths, sponges, and Personal Protective Equipment (PPE) for safety.
    2. Ensure that all cleaning agents are compatible with the material of the drying trays and racks and non-corrosive.
  3. Prepare Cleaning Log
    1. Ensure that the Cleaning Log (Annexure-1) is ready to record cleaning actions, the name of the operator, the time, and any deviations during the process.

5.2 Disassembling the Drying Trays and Racks

If necessary, disassemble the trays and racks for proper cleaning:

  1. Remove Components for Cleaning
    1. Carefully disassemble the trays and racks, including removable trays, filters, and any other detachable components.
    2. Handle each part with care to avoid damage to any sensitive components.
  2. Label Disassembled Parts
    1. Label each disassembled component to ensure correct reassembly after cleaning.
  3. Place Components in Cleaning Stations
    1. Place all disassembled parts in the designated cleaning stations for thorough washing.

5.3 Cleaning Process

Follow these steps to clean the drying trays and racks:

  1. Initial Rinse
    1. Rinse the trays and racks with warm water to remove any residues, dust, or particles from the previous batch.
    2. Ensure all areas, including internal parts, are rinsed thoroughly.
  2. Apply Cleaning Agents
    1. Apply an approved, mild, non-abrasive cleaning agent to the trays and racks. Use soft brushes to scrub surfaces and remove any remaining residues.
  3. Rinse with Warm Water
    1. Rinse all parts thoroughly with warm water to remove any cleaning agents and contaminants.
    2. Ensure that no cleaning agents remain on the trays or racks.
  4. Disinfect (If Required)
    1. If necessary, apply an appropriate disinfectant to the trays and racks to prevent microbial contamination.
    2. Follow the manufacturer’s instructions for proper dilution and use of disinfectants.
  5. Final Rinse
    1. Perform a final rinse with clean warm water to ensure that all disinfectant or cleaning agents are removed.
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5.4 Drying and Reassembly

After cleaning, proceed with drying and reassembly:

  1. Dry the Components
    1. Dry the cleaned trays and racks with a clean, dry, lint-free cloth. Allow parts to air dry completely if necessary.
  2. Reassemble the Equipment
    1. Once dry, carefully reassemble the trays and racks, ensuring all parts are correctly reinstalled and securely fastened.

5.5 Post-Cleaning Inspection

Once cleaning and reassembly are completed, perform the following checks:

  1. Inspect for Residual Contamination
    1. Visually inspect the trays and racks for any remaining cleaning agents, residues, or contamination. If contamination is detected, repeat the cleaning process.
  2. Check for Proper Reassembly
    1. Ensure that all components are correctly reassembled and securely fastened.
  3. Run Test Batch
    1. Run a small test batch of capsules to ensure that the trays and racks are functioning properly and there is no contamination from the previous batch.
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5.6 Documentation

Ensure that the cleaning process is properly documented:

  1. Complete Cleaning Log
    1. Record all cleaning actions, including date, time, operator, actions taken, and any observations or deviations in the Cleaning Log (Annexure-1).
  2. Post-Cleaning Inspection
    1. Document the results of the post-cleaning inspection in the Equipment Inspection Log (Annexure-2).

6. Abbreviations

7. Documents

  1. Cleaning Log (Annexure-1)
  2. Equipment Inspection Log (Annexure-2)
  3. Maintenance Log (Annexure-3)

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: Cleaning Log

Batch ID Cleaning Date Operator Cleaning Action Comments
Batch 001 02/02/2025 John Doe Disassembled and cleaned drying trays and racks No residue found

Annexure-2: Equipment Inspection Log

Equipment ID Inspection Date Inspection Results Operator Next Maintenance Due
Drying Tray 001 02/02/2025 No defects found, equipment fully operational Jane Smith 02/02/2026

Annexure-3: Maintenance Log

Equipment ID Maintenance Date Maintenance Activity Performed By Next Maintenance Due
Drying Tray 001 02/02/2025 Cleaned and recalibrated tray rack system John Doe 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 steps and added post-cleaning inspection Improved process accuracy QA Head
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