and adjusted during the coating process. The QC Manager is responsible for verifying nozzle performance and coating uniformity.

5. Procedure

5.1 Preparation for Monitoring and Adjusting Spray Nozzles

1. Ensure that the coating machine is set up correctly and that the correct coating solution is prepared according to the batch record.
2. Verify that the spray nozzles are installed and connected properly, with no visible signs of damage or blockage.
3. Check that all required equipment for monitoring nozzle performance, such as pressure gauges and spray pattern testers, are available and functional.
4. Review the batch record to confirm the desired spray nozzle settings, including spray pressure, flow rate, and pattern requirements for the coating process.

5.2 Monitoring Spray Nozzles During Coating

1. During the coating process, visually monitor the spray nozzles to ensure that the spray pattern is even and consistent across all tablets.
2. Check for any nozzle blockages or irregularities in the spray pattern, such as droplets clumping or uneven coverage on the tablets.
3. If using automated systems, ensure that the monitoring system is functioning properly and recording data for spray pattern and pressure.
4. Verify the spray pressure regularly using the pressure gauges and ensure that the pressure is within the specified range outlined in the batch record.
5. If a nozzle is found to be clogged or malfunctioning, stop the coating process and clean or replace the nozzle as needed.

5.3 Adjusting Spray Nozzles

1. If the spray pattern is not uniform or the pressure is out of specification, adjust the spray nozzle settings accordingly:
• For uneven spray patterns, adjust the nozzle angle, distance, or the spray pressure to ensure even coverage of the tablet surface.
• If the spray pressure is too low, increase the pressure until the desired spray effect is achieved, ensuring that the coating is applied uniformly.
• If the spray pattern is too fine or too coarse, adjust the flow rate or the spray nozzle type to achieve the correct pattern for the coating material.
2. Re-test the spray pattern after adjustments to ensure uniformity and proper coverage on the tablets.
3. Document any adjustments made to the spray nozzles in the batch record (Annexure-2), including the reason for the adjustment and the new settings used.

5.4 Verifying Nozzle Performance

1. After adjustments, verify the performance of the spray nozzles by performing a test run and ensuring that the coating is applied uniformly to the tablets.
2. Visually inspect the tablets after the test run for any inconsistencies in coating coverage, such as streaks or patches where coating may be missing.
3. If the performance is satisfactory, document the results and continue with the coating process. If the performance is still unsatisfactory, repeat the adjustment process or replace the nozzles.

5.5 Cleaning Spray Nozzles

1. If spray nozzles are found to be clogged or malfunctioning, clean the nozzles thoroughly following the cleaning SOP for coating equipment.
2. Ensure that the nozzles are completely free of any coating residues before reinstallation to prevent future blockages or inconsistencies in the spray pattern.
3. Document any cleaning activities in the batch record and ensure that the nozzles are inspected after cleaning to confirm that they are functioning properly.

5.6 Acceptance Criteria

1. The spray nozzles are considered acceptable if the coating is applied evenly, the spray pattern is uniform, and the pressure is within the specified range.
2. If the spray pattern is irregular or the nozzles cannot be adjusted to meet the specifications, corrective actions must be taken, and re-testing must be performed.

5.7 Post-Testing Actions

1. If the spray nozzles are functioning correctly, proceed with the coating process as planned and monitor the tablets for uniform coating coverage.
2. Ensure that all records related to the nozzle monitoring and adjustments are completed and stored according to the company’s document retention policy.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• CAPA: Corrective and Preventive Action

7. Documents

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

8. References

• USP <701> – Tablet Coating Process Guidelines
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – Coating Process Standards

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	Spray nozzle blockage	Cleaned and adjusted nozzles	John Doe

Annexure-2: Batch Record

Time	Spray Nozzle Adjustment	Tested By
08:00 AM	Adjusted spray pattern and pressure	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 nozzle adjustment procedures	Improved spray pattern adjustment	QA Head