Standard Operating Procedure for Setup and Use of Fluid Bed Dryers
1) Purpose
This SOP provides instructions for the setup and use of fluid bed dryers in the manufacturing of nasal formulations. Fluid bed drying is used for the uniform drying of granular and powdered materials in pharmaceutical production.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of fluid bed dryers at [Company Name].
3) Responsibilities
- Operators: Responsible for setting up and operating the fluid bed dryer according to the product specifications.
- Quality Assurance (QA): Ensures that the drying process meets quality requirements and that the dried material meets product specifications.
- Maintenance Team: Responsible for routine maintenance and calibration of the fluid bed dryer.
4) Procedure
4.1 Pre-Operation Setup
4.1.1 Equipment Inspection
- Inspect the fluid bed dryer to ensure that it is clean, calibrated, and in good working condition. Check that all filters, valves, and blowers are functional.
- Verify that the air filters and dust collection systems are clean and operational. Document the inspection in the equipment log.
4.1.2 Setup for Drying
- Set the drying temperature,
airflow rate, and drying time based on the formulation’s specifications. Record the setup parameters in the Batch Manufacturing Record (BMR).
Load the material to be dried into the fluid bed dryer’s chamber, ensuring even distribution of material across the bed.
4.2 Operation of Fluid Bed Dryer
4.2.1 Starting the Drying Process
- Start the dryer and monitor the temperature, airflow, and drying time throughout the process. Ensure that the material is fluidizing properly and that no clumps are forming.
- Perform in-process checks to ensure that the material is drying uniformly. Record the drying time and temperature at regular intervals.
4.2.2 Sampling and In-Process Testing
- Periodically take samples from the dryer to check the moisture content of the material. Ensure that the moisture content meets the specified limit before proceeding to the next stage of production.
- Document the in-process testing results in the BMR and submit for QA review.
4.3 Post-Operation Activities
4.3.1 Cleaning and Shutdown
- Once the drying process is complete, turn off the dryer and allow it to cool down. Disassemble any removable parts and clean them using an approved cleaning solution.
- Rinse the parts with sterile water and allow them to dry. Document the cleaning process in the cleaning log.
4.3.2 Final Documentation
- Ensure that all drying parameters, in-process checks, and cleaning activities are recorded in the Batch Manufacturing Record (BMR) and equipment log. Submit all documents to QA for approval.
4.4 Maintenance and Calibration
4.4.1 Routine Maintenance
- Inspect the fluid bed dryer weekly for signs of wear, including fan blades, filters, and valves. Replace any worn-out components and document the maintenance in the log.
4.4.2 Annual Calibration
- Calibrate the temperature and airflow control systems annually to ensure accurate drying parameters. Document the calibration results in the calibration log and submit for QA review.
5) Abbreviations, if any
- BMR: Batch Manufacturing Record
- QA: Quality Assurance
6) Documents, if any
- Batch Manufacturing Record (BMR)
- Equipment Log
- Cleaning Log
- Maintenance Log
- Calibration Log
7) References, if any
- Manufacturer’s equipment manual
- Internal SOP for cleaning and maintenance
8) SOP Version
Version 1.0
Annexure
1. Drying Process Log Template
| Date | Batch No. | Drying Temperature (°C) | Drying Time (min) | Airflow Rate (CFM) | Moisture Content (%) | Operator Initials | QA Approval |
|---|---|---|---|---|---|---|---|
| DD/MM/YYYY | Batch Number | Temperature | Time | Airflow Rate | Moisture Content | Operator Name | QA Name |