Standard Operating Procedure for Sugar Coating Process Parameters

Department	Tablet
SOP No.	SOP/TAB/012/2025
Supersedes	SOP/TAB/012/2022
Page No.	Page 1 of 8
Issue Date	09/04/2025
Effective Date	14/04/2025
Review Date	09/04/2026

1. Purpose

This SOP defines the process parameters for sugar coating tablets, ensuring consistent coating quality, uniformity, and proper adhesion of sugar coating to the tablet surfaces.

2. Scope

This SOP applies to the sugar coating process in tablet manufacturing, covering the parameters for coating solution preparation, machine settings, and quality control during the process.

3. Responsibilities

• Manufacturing Personnel: Responsible for setting up the coating machine, applying the sugar coating, and ensuring correct parameters are followed during the process.
• Quality Control (QC): Ensures that the sugar coating process meets all quality specifications, including uniformity, thickness, and appearance of the coating.
• Quality Assurance (QA): Oversees compliance with this SOP, reviews records, and approves any corrective actions taken during the coating process.

4. Accountability

The Production Manager is accountable for ensuring proper execution of the sugar coating process. The QA Manager ensures that the process follows the SOP and meets all regulatory requirements.

5. Procedure

5.1 Sugar Coating Solution Preparation

1. Prepare the sugar coating solution by dissolving sugar, syrup, and other necessary ingredients (e.g., binders, colorants) in the appropriate solvent (e.g., water, ethanol) according to the formulation specifications.
2. Ensure the solution is homogeneously mixed and free from contaminants.
3. Filter the coating solution to remove any impurities before transferring it to the coating machine’s reservoir.

5.2 Coating Machine Setup

1. Ensure that the coating machine is clean and calibrated, with all components free from previous batch residues.
2. Check that the coating drum is securely positioned and is rotating freely.
3. Verify that the spray nozzles are properly installed and calibrated to ensure uniform spraying of the sugar coating solution onto the tablets.
4. Adjust the airflow, temperature, and spray rate according to the coating formulation and product specifications.

5.3 Loading Tablets into the Coating Drum

1. Ensure that tablets are free from any cracks, chips, or defects before loading them into the coating drum.
2. Evenly distribute tablets within the drum to ensure that they tumble properly during the coating process.
3. Verify that the drum is not overfilled to allow for proper coating distribution.

5.4 Sugar Coating Process

1. Start the coating machine and ensure that the spray system is activated and the tablet drum is rotating smoothly.
2. Gradually introduce the sugar coating solution into the spray system while adjusting the spray rate to achieve an even and uniform coating of the tablets.
3. Monitor the coating process to ensure that the tablets are evenly coated and there is no dripping or uneven distribution of the coating solution.
4. Control the temperature and airflow during the process to maintain optimal drying conditions and prevent moisture buildup on the tablets.
5. Continue the process until the desired coating thickness is achieved.

5.5 In-Process Quality Control

1. Perform periodic checks on the coated tablets for uniformity, appearance, and coating thickness during the coating process.
2. Check the tablets for defects such as uneven coating, cracking, or streaking, and adjust the spray rate, temperature, or coating solution as necessary.
3. Record all in-process quality control data in the batch record (Annexure-1).

5.6 Drying Process

1. Ensure that the tablets are dried adequately after coating to prevent any tackiness or adhesion between tablets.
2. Monitor the drying time and temperature to ensure the tablets are thoroughly dried without overheating or causing coating degradation.
3. Use moisture content testing methods to verify that tablets have reached the desired moisture levels (e.g., using a moisture analyzer or loss on drying method).

5.7 Post-Coating Inspection

1. After the coating process is complete, perform a visual inspection of the coated tablets to check for uniformity, appearance, and defects such as cracking or chipping.
2. Ensure that the coating thickness is consistent across the batch and meets the product specifications.
3. Perform any necessary corrective actions if defects are observed, such as adjusting the coating process or reworking tablets that do not meet quality standards.

5.8 Equipment Shutdown and Cleaning

1. Once the sugar coating process is completed, turn off the machine and clean all parts that came into contact with the coating material (e.g., spray nozzles, tablet drum, collection container).
2. Use an approved cleaning method and ensure that all equipment is thoroughly cleaned to prevent cross-contamination between batches.
3. Record all cleaning activities in the cleaning log (Annexure-2).

5.9 Documentation and Record-Keeping

1. Document all process parameters, including solution preparation, machine setup, coating process, in-process checks, and final inspection in the batch record.
2. Ensure that all records are reviewed and signed off by the responsible personnel and stored for regulatory compliance.
3. Document any deviations from the standard process and corrective actions taken in the batch record.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• CoA: Certificate of Analysis

7. Documents

1. Coating Batch Record (Annexure-1)
2. Cleaning Log (Annexure-2)

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: Coating Batch Record

Batch Number	Tablet Type	Coating Solution	Spray Rate	Tablet Weight	Coating Thickness	Remarks
Batch 001	Tablet A	Sugar Coating	6 g/min	500 mg	15 µm	Within specifications
Batch 002	Tablet B	Sugar Coating	7 g/min	510 mg	18 µm	Minor adjustment needed

Annexure-2: Cleaning Log

Equipment	Cleaning Date	Cleaning Method	Personnel
Coating Machine 1	08/04/2025	Washing with detergent and rinsing with water	John Doe
Coating Machine 2	09/04/2025	Washing with detergent and rinsing with water	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 Coating Process Parameters	Optimization of Sugar Coating Process	QA Head