Standard Operating Procedure for Use of Fluid Bed Dryers in API Processing

Department	API Manufacturing
SOP No.	SOP/API/071/2025
Supersedes	SOP/API/071/2022
Page No.	Page 1 of 10
Issue Date	13/04/2025
Effective Date	15/04/2025
Review Date	13/04/2026

1. Purpose

To define the procedure for the use of fluid bed dryers (FBD) in the drying of APIs and intermediates, ensuring efficient moisture reduction, uniform drying, and adherence to cGMP requirements.

2. Scope

This SOP applies to all drying operations using fluid bed dryers in the API manufacturing unit, including equipment preparation, operation, monitoring, unloading, and cleaning.

3. Responsibilities

• Production Operator: Operate the FBD as per process parameters and ensure safety during use.
• Production Supervisor: Review dryer setup, monitor process, and verify completion of documentation.
• QA Department: Ensure compliance with SOP, perform line clearance, and review batch records.
• Engineering Department: Maintain FBD and associated utilities and perform preventive maintenance.

4. Accountability

The Production Head is accountable for execution of drying using the FBD. QA Head is responsible for final approval and regulatory compliance review.

5. Procedure

5.1 Pre-Operation Checks

1. Ensure FBD is cleaned and labeled “Cleaned”.
2. Verify calibration status of inlet and exhaust temperature sensors, differential pressure gauges, and control panels.
3. Check integrity of FBD filter bags and record observations in the checklist.
4. Review line clearance from QA before loading the batch.

5.2 Charging Material into FBD

1. Transfer material from containers to the FBD bowl using a closed transfer system or under LAF.
2. Note the batch number, product name, weight of wet material, and date in the drying logbook.
3. Securely attach the bowl to the FBD column and ensure proper gasket sealing.

5.3 Drying Operation

1. Set the following parameters as per BMR:
   • Inlet temperature (e.g., 60–80°C)
   • Drying time (e.g., 20–40 minutes)
   • Fluidization air velocity
   • Target LOD or moisture level
2. Start blower to initiate fluidization.
3. Turn on heaters and monitor drying cycle in the PLC (if automated) or manually.
4. Record temperature, time, and airflow every 10–15 minutes in “FBD Operation Log” (Annexure-1).
5. Stop heating once in-process LOD result is within limits.

5.4 Unloading and Post-Drying Steps

1. Allow cooling of the material before unloading.
2. Discharge dry API into clean, labeled containers or drums lined with polybags.
3. Label each drum with:
   • Product Name
   • Batch No.
   • Net Weight
   • Drying Date
4. Send final sample to QC for testing and retain samples as per retention policy.

5.5 Cleaning and Maintenance

1. Clean product contact parts with suitable cleaning agent as per cleaning SOP.
2. Dry and inspect before labeling “Cleaned”.
3. Record cleaning in equipment cleaning logbook.
4. Engineering team shall perform periodic inspection and preventive maintenance.

6. Abbreviations

• FBD: Fluid Bed Dryer
• LOD: Loss on Drying
• SOP: Standard Operating Procedure
• QA: Quality Assurance
• QC: Quality Control
• BMR: Batch Manufacturing Record

7. Documents

1. FBD Operation Log (Annexure-1)
2. Cleaning Logbook
3. Batch Manufacturing Record

8. References

• ICH Q7 – GMP for Active Pharmaceutical Ingredients
• Internal Equipment Operation Manual
• US FDA 21 CFR Part 211

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: FBD Operation Log

Date	Batch No.	Start Time	End Time	Inlet Temp (°C)	LOD (%)	Operator
13/04/2025	API-FBD-20250413	09:15	09:50	70	0.35

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial SOP Release	New Equipment Qualification	QA Head
13/04/2025	2.0	Added Inlet/Exhaust Monitoring and Validation Parameters	Process Optimization	QA Head