Standard Operating Procedure for Fluidised Bed Dryer (FBD)
The purpose of this SOP is to establish a standard procedure for operating the Fluid Bed Dryer.
This SOP applies to the Fluid Bed Dryer in the granulation area of the production section.
3.1 Machine Operator is responsible for operating the Fluidised Bed Dryer.
3.2 Production Incharge Pharmacist is responsible for the implementation of this SOP.
3.3 The Production Manager is responsible for ensuring the implementation of this SOP.
3.4 Quality Assurance inspector monitors the compliance of this SOP.
4.1 Production pharmacist will ensure that the Fluidised Bed Dryer and the area are properly cleaned.
4.2 Production pharmacist will ensure that the Fluidised Bed Dryer and Area is labelled with relevant Product labels.
4.3 Now start the Fluid Bed Dryer by switching ON the main power supply.
4.4 When the main power supply is ON, rotate the knob to ON the HMI of the Fluidised Bed Dryer.
4.5 When HMI is ON, select the language and enter the password to go to the main display.
4.6 Now Press the Deflate button to deflate the product trolley.
4.7 Pull the product trolley out and ensure that the filter bag or SS filters are properly installed.
4.8 Now add wet granules to the product trolley and install it over the bowl of the Fluidised Bed Dryer.
4.9 Press the inflate button on the HMI of the Fluidised Bed Dryer to properly seal the product trolley with the drying chamber of FBD ( Fluidised Bed Dryer)
4.10 After sealing the product trolley, insert the product temperature sensor into its port.
4.11 Now select the saved recipe from the list or enter parameters manually according to the BMR.
4.12 Following parameters are added
- Inlet Air Temperature
- Fan Motor Speed
- Drying Time
- Filter Shaking Time
- Scraper Rotation Time
4.13 After parameters selection, open the inlet air gate by pressing the gate Opening button.
4.14 Drying process will start according to the feed recipe.
4.15 Ensure that filter shaking and powder scraper rotation is according to the feed intervals, if operating in manual mode, press filter shaking and scraper rotation buttons at specified time intervals to ensure proper drying.
4.16 When drying is completed, take the sample of granules from the sample port and check its LOD (Loss On Drying).
4.17 If LOD is according to the BMR specified limit, collect or remove the dried granules in the containers.
4.18 Check the weight of granules to calculate the product yield and mention it in the BMR.
4.19 Affix to be cleaned,label on FBD and record the activity in the logbook of the fluid bed dryer and sign it.
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 FBD: Fluidised Bed Dryer
5.5 LOD: Loss On Drying