The purpose of this SOP to describe the procedure for the operation of fluidized bed dryer (FBD).
This SOP is applicable for operation of fluidized bed dryer located in the tablet production department at Manufacturing site..
Equipment Name : Fluidized Bed Dryer.
Equipment ID No. :
Manufactured by :
Production Officer/ Executive shall be responsible to supervise the operation of fluidized bed dryer.
IPQA Officer/ Executive shall be responsible for verifying the operation of fluidised bed dryer.
Head Production shall be responsible to check the procedure is followed as per SOP.
SOP : Standard operating procedure.
IPQA : In Process Quality Assurance.
FBD : Fluidized Bed Dryer.
I.D. No. : Identification Number
GENERAL INSTRUCTIONS :
Check the cleanliness of fluidized bed dryer, its part and area.
Check the ‘CLEANED’ status label available on fluidized bed dryer.
Check the integrity of FBD bowl sieve and inspect the intactness of finger bag.
Check the proper fixing of finger bags, retarding chamber and bowl.
These FBD bags should be stored in separate bins and should be properly labeled.
Use dedicated FBD bag for each product and then check the proper fitting of FBD bag.
Check the steam filter before applying.
After charging powder in FBD bowl push the trolley in the dryer.
Check whether the earthling provided on the dryer are touching the FBD trolley.
Steam indicator valve to be checked during operation.
Operation of Fluidized Bed Dryer:
Before starting the operation production officer / executive shall affix the activity status label having the details such as product name, B.No. Stage etc. to equipment and area and inform to IPQA officer / executive for line clearance.
Adjust the FBD bowl under the retarding chamber.
Switch ‘ON’ the mains. Open the compressed air valve to apply pneumatic pressure 2.5 kg to 3.5 kg to lock the bowl.
While starting steam drying, Keep steam valve and by pass valve open initially to drain the condensed water passing through the pipe. Close the condensed valve and adjust the steam valve so as to get the required air inlet temperature. Adjust the timer as per batch manufacturing record.
Ensure that there is no leakage of air from FBD bowl and outlet.
Remove the container after shaking and rack the material. Again reset the product container and run for further drying. Take out the granules intermittently from the sampling points as and when required for checking the loss on drying.
After completion of operation shut ‘OFF’ the steam valve and air dry the material till the granules attains ambient temperature.
Shake the FBD bag and allow the material to settle down.
Release the compressed air pressure to unlock the FBD bowl from the retarding chamber.
Remove the product container or go for the further process.
Affix “To be Cleaned “label to equipment .
Record the operation activity in equipment log sheet as per annexure – I.
Inspection of FBD bag shall be carried out for its integrity as per below given points
- Check bag for any small holes and torn.
- Check the finger of bag for stitches are intact.
- Check the corners of bag for intactness and stitches of corners .
Inspection of FBD bag shall be carried out for its integrity before and after the usage and record it in FBD bag usage record as per annexure –II.
After completion of operation clean the equipment as per cleaning procedure.
Annexure – I : Equipment Log Sheet.
Annexure – II : FBD Bag Usage Record.