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

• Manufacturing Personnel: Responsible for operating the automated spray coating system and ensuring proper application of the coating according to the batch record.
• Quality Control (QC): Responsible for verifying the uniformity and quality of the coating, including inspecting the tablets after the coating process.
• Quality Assurance (QA): Ensures compliance with this SOP and oversees the validation of the coating process.
• Maintenance Personnel: Responsible for maintaining and calibrating the spray coating equipment to ensure its optimal performance.

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.

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.

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).

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient

7. Documents

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

8. References

• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• EU GMP Guidelines Part I – Basic Requirements for Medicinal Products
• ICH Q7 – Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

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