Standard Operating Procedure for Calibration of Fluid Bed Processor for Granulation

Department	Tablet
SOP No.	SOP/TAB/064/2025
Supersedes	SOP/TAB/064/2022
Page No.	Page 1 of 6
Issue Date	30/12/2025
Effective Date	05/01/2026
Review Date	30/12/2026

1. Purpose

The purpose of this Standard Operating Procedure (SOP) is to provide guidelines for the calibration of the Fluid Bed Processor used in the granulation process of tablet manufacturing. Calibration ensures that the equipment performs accurately and consistently, which is critical for producing uniform granules with the desired properties.

2. Scope

This SOP applies to the calibration of Fluid Bed Processors used in the tablet granulation process. It covers the calibration of temperature, airflow, and humidity controls, which directly influence the quality of the granules produced.

3. Responsibilities

• Manufacturing Personnel: Responsible for ensuring the fluid bed processor is set up correctly and for assisting with calibration activities. They must follow the procedures outlined in this SOP.
• Quality Control (QC): Responsible for verifying that the fluid bed processor is calibrated and operating within the required specifications. QC will also perform periodic checks during production to ensure continued compliance.
• Maintenance Personnel: Responsible for performing the actual calibration of the fluid bed processor, ensuring that the equipment is maintained and functioning according to the manufacturer’s specifications.
• Quality Assurance (QA): Ensures that the calibration procedure follows this SOP and that all required records are completed and maintained properly.

4. Accountability

The Production Manager is accountable for ensuring that the fluid bed processor is calibrated prior to production and that all calibration activities are documented. The QA Manager is responsible for verifying that the calibration process is followed and ensuring the equipment is suitable for granulation.

5. Procedure

5.1 Pre-Calibration Setup

1. Ensure that the Fluid Bed Processor is clean and free from any previous batch residues. Perform a thorough inspection to verify the condition of the equipment.
2. Ensure that all necessary calibration tools, such as thermocouples, flow meters, and humidity sensors, are available and in good working condition.
3. Verify that the equipment has been correctly installed and that all connections (e.g., electrical, air supply) are secure and functioning properly.
4. Ensure that the operator is trained in the calibration procedure and understands the importance of accurate calibration for the granulation process.

5.2 Calibration of Temperature

1. Place a calibrated thermocouple at multiple points in the fluid bed processor to measure the air temperature and bed temperature (top, middle, and bottom of the chamber).
2. Turn on the fluid bed processor and set it to the desired temperature as specified in the batch record.
3. Allow the equipment to reach the set temperature. Monitor the temperature readings at each of the measured points.
4. If the temperatures are within the required tolerance range (±2°C), the calibration is complete for temperature. If any deviations are found, adjust the temperature settings and retest until the equipment is calibrated within the specified range.

5.3 Calibration of Airflow

1. Attach a calibrated anemometer or airflow sensor to the inlet and outlet of the fluid bed processor.
2. Turn on the equipment and set the airflow rate to the specified value in the batch record.
3. Measure the airflow at multiple points, including the inlet and outlet of the fluid bed chamber, and ensure that the airflow is consistent with the set parameters.
4. If the airflow is within the acceptable range, document the calibration results. If any discrepancies are found, adjust the airflow and retest until the correct values are achieved.

5.4 Calibration of Humidity

1. Place a calibrated humidity sensor at the air inlet and within the fluid bed chamber to measure the relative humidity.
2. Turn on the equipment and allow it to stabilize at the specified humidity level as defined in the batch record.
3. Ensure that the humidity within the chamber matches the set parameters. If necessary, adjust the humidity control system and retest until the desired levels are achieved.
4. Document all readings and any adjustments made to the humidity control system during calibration.

5.5 Post-Calibration Check

1. Once the temperature, airflow, and humidity have been calibrated, perform a final operational check of the fluid bed processor to ensure all parameters are working in sync.
2. Run a trial batch to verify that the fluid bed processor maintains the set conditions throughout the granulation process. Monitor for any irregularities in temperature, airflow, or humidity.
3. Document the trial run results, ensuring that the equipment operates within specifications for the entire batch.

5.6 Documentation and Record-Keeping

1. Document all calibration results, including temperature, airflow, and humidity readings, in the calibration log (Annexure-1). Include any deviations and corrective actions taken during the process.
2. Ensure that all calibration data is signed and dated by the responsible personnel.
3. Maintain records of all calibration activities in compliance with the company’s record retention policy and ensure that they are available for audits or inspections.

5.7 Calibration and Maintenance Frequency

1. Perform calibration of the fluid bed processor at the start of each production run, as well as periodically as specified in the preventive maintenance schedule.
2. Ensure that calibration activities are conducted annually or as recommended by the equipment manufacturer.
3. Ensure that maintenance checks are carried out according to the manufacturer’s recommended schedule to ensure continuous optimal performance of the fluid bed processor.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• API: Active Pharmaceutical Ingredient
• HPLC: High-Performance Liquid Chromatography

7. Documents

1. Calibration Log (Annexure-1)
2. Equipment Maintenance 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: Calibration Log

Calibration Date	Temperature (°C)	Airflow (m³/h)	Humidity (%)	Comments
15/12/2025	45°C	200 m³/h	50%	Calibration verified, within spec

Annexure-2: Equipment Maintenance Log

Maintenance Date	Equipment Component	Maintenance Performed	Performed By	Comments
10/12/2025	Fluid Bed Processor	Calibration and inspection	John Doe	No issues found, equipment ready

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 Parameters	Improved Equipment Accuracy	QA Head