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SOP for FBD


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 & outlet.
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 Loss on Drying (LOD).
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 logbook”.
•  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
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
Email: .moc.enilediugamrahp@ofni Need Help: Ask Question


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