Standard Operating Procedure for Coating Machine Calibration and Setup
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/010/2025 |
| Supersedes | SOP/TAB/010/2022 |
| Page No. | Page 1 of 8 |
| Issue Date | 30/03/2025 |
| Effective Date | 04/04/2025 |
| Review Date | 30/03/2026 |
1. Purpose
To outline the process for calibrating and setting up the coating machine, ensuring uniform coating of tablets, and that all operational parameters are met according to the product specifications.
2. Scope
This SOP applies to the calibration, setup, and operation of the coating machine for tablet coating, including the setup of equipment and verification of operational parameters.
3. Responsibilities
- Manufacturing Personnel: Responsible for setting up and operating the coating machine and ensuring correct calibration and machine settings during operation.
- Quality Control (QC): Responsible for verifying that the coating process is consistent with the defined specifications, performing quality checks on the coated tablets, and ensuring equipment calibration is accurate.
- Quality Assurance (QA): Responsible for overseeing the entire coating process, ensuring compliance with SOP, and reviewing and approving all records and deviations.
4. Accountability
The Production Manager is accountable for the proper operation and setup of the coating machine. The QA Manager is responsible for ensuring compliance with this SOP and regulatory standards.
5. Procedure
5.1 Equipment Inspection and Setup
- Ensure the coating machine is clean and free from any residue from previous batches.
- Inspect all components of the coating machine, including spray guns, air pressure regulators, and temperature controllers, to ensure they are properly functioning.
- Verify that the machine is equipped with the correct tablet drum size and that the drum is properly aligned and free from damage.
- Check for proper air filtration and circulation systems, ensuring no blockages or leaks.
- Ensure that the coating material (e.g., sugar, film coating) is properly prepared and available for use.
5.2 Calibration of Coating Machine
- Calibrate the spray nozzles according to the manufacturer’s specifications to ensure uniform and accurate coating distribution.
- Verify the airflow rate, pressure, and temperature settings to ensure they are within the prescribed limits for the coating process.
- Perform a test run without tablets to check the spray pattern and adjust as necessary to achieve a consistent coating spray.
- Record calibration results in the equipment log for future reference and verification (Annexure-1).
5.3 Coating Material Preparation
- Prepare the coating solution by mixing the coating agent with the appropriate solvent (e.g., water, ethanol) as per the formulation guidelines.
- Ensure the coating material is filtered to remove any contaminants before it is loaded into the coating machine’s reservoir.
- Verify that the coating material is the correct batch and within its expiry date, checking the Certificate of Analysis (CoA) for quality assurance.
5.4 Loading Tablets into the Coating Machine
- Ensure that the tablets are properly prepared and free from defects (e.g., chips or cracks) before loading into the coating drum.
- Carefully load the tablets into the coating drum, ensuring that they are evenly distributed and not overcrowded to allow for optimal coating.
- Verify that the tablet feed mechanism is functioning properly to prevent blockage during the coating process.
5.5 Coating Process
- Start the coating machine, ensuring that the spray system is activated and the tablets are tumbling evenly inside the drum.
- Gradually introduce the coating material into the system, adjusting the flow rate to ensure a uniform coating.
- Monitor the tablet surface throughout the process to check for uniformity and avoid over-coating or under-coating.
- Adjust the airflow, temperature, and spray rate if needed to achieve the desired coating thickness.
- Ensure that tablets are coated evenly and that there are no defects such as uneven coverage, drips, or streaks.
5.6 In-Process Quality Control
- During the coating process, regularly sample the tablets and inspect them for uniformity, appearance, and coating thickness.
- Perform physical tests, such as checking for coating defects, tablet integrity, and adhesion quality (e.g., peel resistance, gloss, etc.).
- If any tablets show defects (e.g., uneven coating, cracks), stop the process and investigate possible causes. Make adjustments as necessary.
- Record all in-process checks in the batch record (Annexure-2) and ensure that results are documented and signed off by the responsible personnel.
5.7 Final Coating Inspection and Drying
- After completing the coating process, check the tablets for appearance and ensure the coating has dried properly without any tackiness.
- If the coating appears wet, adjust the drying time or temperature settings to ensure complete drying of the tablets.
- Perform the final inspection for coating defects and record the results in the batch record.
- Ensure the tablets are stored in an appropriate environment until the next stage in the process (e.g., packaging).
5.8 Equipment Shutdown and Cleaning
- Once the coating process is complete, turn off the machine and clean all parts that have come into contact with the coating material according to the cleaning SOP.
- Ensure that the spray nozzles, drum, and other components are thoroughly cleaned to avoid cross-contamination in future batches.
- Record cleaning details in the equipment log, including the date, cleaning method, and personnel responsible (Annexure-3).
5.9 Documentation and Record-Keeping
- Ensure that all steps of the coating process, including calibration, machine settings, in-process checks, and adjustments, are documented in the batch record.
- Sign off on the batch record to confirm the successful completion of the coating process, and store all records for regulatory compliance.
- Ensure that all relevant quality control data is properly documented, including any deviations and corrective actions taken during the process.
6. Abbreviations
- SOP: Standard Operating Procedure
- GMP: Good Manufacturing Practice
- QC: Quality Control
- QA: Quality Assurance
- CoA: Certificate of Analysis
7. Documents
- Coating Batch Record (Annexure-1)
- Coating Quality Control Log (Annexure-2)
- Equipment Cleaning 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: Coating Batch Record
| Batch Number | Tablet Type | Coating Material | Spray Rate | Tablet Weight | Remarks |
|---|---|---|---|---|---|
| Batch 001 | Tablet A | Sugar Coating | 5 g/min | 500 mg | Within specifications |
| Batch 002 | Tablet B | Film Coating | 7 g/min | 510 mg | Minor adjustment needed |
Annexure-2: Coating Quality Control Log
| Batch Number | Test Performed | Result | Test Date | QC Personnel |
|---|---|---|---|---|
| Batch 001 | Coating Thickness | Pass | 30/03/2025 | John Doe |
| Batch 002 | Tablet Appearance | Pass | 31/03/2025 | Jane Smith |
Annexure-3: Equipment Cleaning Log
| Equipment | Cleaning Date | Cleaning Method | Personnel |
|---|---|---|---|
| Coating Machine 1 | 30/03/2025 | Washing with detergent and rinsing with water | John Doe |
| Coating Machine 2 | 31/03/2025 | 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 Calibration Process | Standardization of Calibration and Coating Process | QA Head |