SOP Guide for Pharma

Tablets: SOP for Cleaning Checks Between Granulation Batches – V 2.0

Auditor

Tablets: SOP for Cleaning Checks Between Granulation Batches – V 2.0

Standard Operating Procedure for Cleaning Checks Between Granulation Batches

Department Tablet
SOP No. SOP/TAB/164/2025
Supersedes SOP/TAB/164/2022
Page No. Page 1 of 6
Issue Date 01/03/2026
Effective Date 06/03/2026
Review Date 01/03/2027

1. Purpose

To define the procedure for conducting cleaning checks between granulation batches to ensure equipment is free from residue, cross-contamination, and any other particles that could compromise the quality of the next batch.

2. Scope

This SOP applies to all equipment used in the granulation process, including mixers, blenders, and other related equipment, to ensure thorough cleaning between batches of tablet manufacturing.

3. Responsibilities

4. Accountability

The Production Supervisor is accountable for ensuring that the cleaning checks are performed according to this SOP. The QC Manager is responsible for verifying the effectiveness of the cleaning and ensuring all cleaning checks are documented properly.

See also  Tablets: SOP for Inspection of Granule Flow Properties During Compression - V 2.0

5. Procedure

5.1 Preparation for Cleaning Checks

  1. Ensure that the equipment has been turned off and is safe to clean.
  2. Remove any remaining granulation material from the equipment, including all trays, bowls, and containers.
  3. Verify that the cleaning agents and tools (e.g., cleaning wipes, brushes, water, and other cleaning materials) are available and appropriate for the type of equipment being cleaned.
  4. Ensure that all required Personal Protective Equipment (PPE) is worn during the cleaning process, including gloves, face shields, and lab coats.

5.2 Cleaning the Equipment

  1. Perform a first-stage cleaning to remove any loose powder or granulation material from the equipment surfaces.
  2. Use appropriate cleaning agents and tools to scrub the equipment and remove any remaining granulation residue. Ensure that all parts, including internal surfaces and hard-to-reach areas, are thoroughly cleaned.
  3. Rinse the equipment with clean water to remove any cleaning solution residue.
  4. If required, perform a final rinse with purified water to ensure that no cleaning agent residue remains.

5.3 Cleaning Checks

  1. Conduct a visual inspection to ensure that all surfaces of the equipment are free of visible residue, powder, or cleaning agent.
  2. Perform swab testing on critical areas (e.g., mixing surfaces, transfer hoses) to verify that no residues remain. Use appropriate swabbing materials and solvents to collect samples.
  3. Ensure that swab tests are performed in accordance with the validation standards, with results documented in the batch record (Annexure-2).
  4. If the visual inspection or swab testing reveals any contamination or residue, repeat the cleaning process in the affected areas and re-test.
See also  Tablets: SOP for Tablet Temperature Control During Compression - V 2.0

5.4 Documentation of Cleaning Checks

  1. Document the results of the visual inspection and swab tests in the batch record (Annexure-2), including the time, date, equipment cleaned, and any corrective actions taken.
  2. Ensure that the batch record is signed off by the Production Operator and QC personnel to confirm that the equipment is clean and ready for use in the next batch.

5.5 Corrective Actions for Cleaning Failures

  1. If cleaning checks fail (i.e., residues or contamination are found), investigate the root cause, which may include insufficient cleaning agents, improper cleaning techniques, or missed areas during the cleaning process.
  2. Adjust the cleaning process as needed, such as using stronger cleaning agents, improving the cleaning technique, or adding additional rinsing steps.
  3. Re-clean the equipment, perform another round of cleaning checks, and re-test until all results are within acceptable limits.
  4. Document all corrective actions in the deviation report (Annexure-1) and ensure the investigation is reviewed by QA for compliance.

5.6 Acceptance Criteria

  1. The equipment is considered acceptable for use in the next batch if no visible residues or contamination are present and all swab tests return negative results.
  2. If cleaning failures are identified and corrective actions are successful, the batch may be approved, and production may proceed after re-validation of the cleaning process.
  3. If the cleaning process cannot be completed successfully after corrective actions, the equipment should be removed from service, and further investigation should be conducted.

5.7 Post-Testing Actions

  1. If the cleaning checks are successful, proceed with the setup and preparation for the next granulation batch.
  2. Ensure that all cleaning documentation is filed according to the company’s document retention policy and is available for audit purposes.
See also  Tablets: SOP for Adhesion Testing of Coated Tablets During Production - V 2.0

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)

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: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Residues found in the granulation mixer after cleaning Re-cleaned mixer with additional cleaning agents and extended rinse time John Doe

Annexure-2: Batch Record

Equipment Cleaning Completed (Y/N) Inspection Result Swab Test Result Tested By
Granulation Mixer Y No residues found Negative Jane Smith

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 verification process Improved cleaning checks and documentation QA Head
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