SOP for Setup and Use of Fluid Bed Dryers

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