SOP for FBD

Categories: Production , SOP

Apr 12, 2011

Standard operating procedure of Fluidised Bed Dryer used in drying during tablet manufacturing.

1.0 OBJECTIVE:
To lay down the procedure for Operation of Fluidised Bed Dryer.

2.0 SCOPE:
This SOP shall be applicable for Fluidised Bed Dryer Capacity-200 kg in
Granulation area in Production department.

3.0 RESPONSIBILITY:
3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above

4.0 ACCOUNTABILITY:
HOD-Production/Assigned Designee

5.0 PROCEDURE:
5.1 Production person shall ensure the cleanliness of the Fluidised Bed
Dryer, its part & area and ‘CLEANED’ label on it.
5.2 Check the integrity of FBD bowl sieve, and inspect the intactness of
finger bag.
5.3 Check proper fixing of finger bags, retarding chamber & bowl.
5.4 Before starting the operation production person get the line clearance
from Q.A person and affix the status label with Product Name, Batch Details
to equipment & area.
5.5 Adjust the FBD Bowl under the retarding chamber.
5.6 Put “ON” the mains.
5.7 Check that pressure is proper in pressure indicating switch i.e 0.210 to
0.250 kg/cm2 for panel pressure & 2.0 to 2.60 kg/cm2 for inflatable tube.
Pressure indicating switch show green color. Main screen display in Human
Machine Interface. Then press login switch & enter the password 1, 2, 3 & 4.
Main screen will show with manual & auto mode.
5.8 For manual mode – press two times “Manual” & then press “manual
action”, green indicator will glow on top of screen.
5.9 Main screen shows in front with finger bag seal, FBD bowl seal then
press for FBD bag sealing after this press for FBD bowl sealing.
5.10 After this press the “NEXT” again screen with inlet temperature,
product temperature & outlet temperature indicating. Set all parameter
according to Batch Manufacturing Record & then open the inlet damper
between 10-90 % as per product.
5.11 Then press “PREVIOUS” in screen & finally press exhaust blower & start
the drier for 2 minutes.
5.12 Keep the dampers of air inlet and outlet at pre-decided positions and
adjust timer as per Batch Manufacturing Record.
5.13 Ensure that there is no leakage of air from FBD bowl & out let.
5.14 Stop the drier and remove the trolley. Load the material which is to be
dried. Push the trolley below the retarding chamber and seal the trolley with
the help of HMI & start the air drying process for 5-10 minute or as per BMR.
5.15 Remove the product container after shaking & rack the material. Again
reset the product container & run for further drying. Take out the granules
intermittently from the sampling point as and when required for checking
the LOD (Loss on Drying).
5.16 After completion of operation, stop the drier. Before moving the trolley,
shake the bag thoroughly with the help of shaking piston provided in HMI.
5.17 Unload the dried material in process bins or go for the further process.
5.18 For Auto mode – press the “auto mode” & then login by entering
password. Seal the bag & FBD bowl through HMI.
5.19 Set the parameter as per batch manufacturing record in HMI & run the
dryer and after completion of drying shake the bag.
5.20 Remove the product container & go for further process.
5.21 Affix “To Be Cleaned” label & fill the “Equipment Log Book”.
NOTE:
• Dedicated finger bags to be used for each product on API (Active
Pharmaceutical Ingredient) basis.
• These bags should be stored in separate bins & should be properly
labeled.
• Inspection of FBD bag is carried out for its integrity Before & after the
usage and record in “FBD bag log book”.
• The new bag is procured it will be inspected and given the new I.D.No.
(Identification No.), and if FBD Bag is found torned or with holes formed in it
or unsuitable in any respect for usage, then it is to be replaced immediately
and record it in “FBD bag Inward, issuance & Destruction Register”.
6.0 ABBREVIATIONS:
6.1 SOP : Standard Operating Procedure
6.2 FBD : Fluidized Bed Dryer
6.3 HMI : Human Machine Interface
6.4 BMR : Batch Manufacturing Record
6.5 LOD : Loss On Drying
6.6 API : Active Pharmaceutical Ingredient