SOP Guide for Pharma

Tablets: SOP for Using Automated Spray Coating Systems – V 2.0

Auditor

Tablets: SOP for Using Automated Spray Coating Systems – V 2.0

Standard Operating Procedure for Using Automated Spray Coating Systems

Department Tablet
SOP No. SOP/TAB/066/2025
Supersedes SOP/TAB/066/2022
Page No. Page 1 of 6
Issue Date 10/01/2026
Effective Date 15/01/2026
Review Date 10/01/2027

1. Purpose

To provide guidelines for the use of automated spray coating systems to ensure uniform and consistent coating application during tablet manufacturing.

2. Scope

This SOP applies to the operation of automated spray coating systems used in the coating of tablets during the manufacturing process.

3. Responsibilities

4. Accountability

The Production Manager is accountable for ensuring that the automated spray coating system is used properly and efficiently. The QA Manager is responsible for ensuring compliance with the SOP and approving the batch for further processing.

5. Procedure

5.1 Pre-Coating Setup

  1. Ensure that the automated spray coating system is clean and free of contamination from previous batches.
  2. Check that the system is correctly set up with all necessary components, including spray nozzles, pumps, and temperature controls.
  3. Prepare the coating solution according to the batch record specifications. Ensure the solution has the correct viscosity and is filtered to remove any particulate matter.
  4. Load the tablets into the coating pan or tray, ensuring they are evenly distributed and able to rotate or tumble within the system.
  5. Verify that the system is calibrated, with the spray rate, pan speed, and air pressure set according to the batch record.
See also  Tablets: SOP for Applying Protective Seal Coating for Sugar-Coated Tablets - V 2.0

5.2 Operating the Automated Spray Coating System

  1. Start the spray coating system and allow the equipment to stabilize at the set parameters.
  2. Monitor the spray nozzle to ensure that the coating solution is being applied evenly across the tablets.
  3. Ensure the coating pan or tray rotates or tumbles the tablets uniformly to ensure uniform coverage.
  4. Adjust the spray rate, pan speed, or air pressure if necessary to maintain consistent and uniform coating throughout the process.
  5. Periodically check the tablets to confirm that the coating is being applied evenly and that the tablets are not stuck together or over-coated.

5.3 Monitoring the Coating Process

  1. Check the tablets periodically during the coating process for uniformity of appearance and ensure there are no defects such as uneven coating or streaking.
  2. Measure the coating weight at regular intervals to ensure the tablets meet the specified coating weight as per the batch record.
  3. If any issues are detected, such as uneven coating or excessive buildup, adjust the process parameters (e.g., spray rate, pan speed, or airflow) and resume the coating process.
See also  Tablets: SOP for Real-Time Monitoring of Tablet Coating Thickness - V 2.0

5.4 Post-Coating Inspection

  1. Once the coating process is complete, perform a visual inspection of the tablets to check for uniformity and appearance.
  2. Measure the coating thickness on a sample of tablets to confirm that the coating meets the required specifications.
  3. Ensure that the tablets are free from defects such as cracks, chips, or uneven coatings.
  4. If any defects are identified, remove the defective tablets from the batch or perform rework as per the deviation report (Annexure-1).

5.5 Documentation and Record-Keeping

  1. Document all coating parameters, including spray rate, pan speed, air pressure, and coating weight, in the batch record (Annexure-2).
  2. Record any deviations from the prescribed parameters in the deviation report (Annexure-1), including corrective actions taken.
  3. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.

5.6 Calibration and Maintenance of Coating Equipment

  1. Ensure that the spray coating system is regularly calibrated according to the manufacturer’s specifications.
  2. Perform routine maintenance on the system, including cleaning and inspection of spray nozzles, pumps, and temperature controls, to ensure optimal performance.
  3. Document all calibration and maintenance activities in the equipment maintenance log (Annexure-3).
See also  Tablets: SOP for Heat Application during Sugar Coating Process - V 2.0

6. Abbreviations

7. Documents

  1. Batch Record (Annexure-2)
  2. Deviation Report (Annexure-1)
  3. Equipment 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: Deviation Report

Deviation Date Batch Number Deviation Description Corrective Action Responsible Person
15/12/2025 Batch 001 Uneven coating Adjusted spray rate John Doe

Annexure-2: Batch Record

Batch Number Spray Rate Pan Speed Air Pressure Coating Weight
Batch 001 50 ml/min 10 rpm 1 bar 5 mg

Annexure-3: Equipment Maintenance Log

Maintenance Date Equipment Maintenance Performed Performed By Comments
01/12/2025 Automated Spray Coating System Calibration and Inspection Jane Smith Equipment ready for use

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 Coating Parameters Improved Efficiency QA Head
Exit mobile version