Qualification of FBD.pptx

Fluidized Bed Dryer
Principle of FBD
Construction of FBD
Working of FBD
Steps of Fluidization
Qualification of FBD
Design Qualification
Installation Qualification
Operational Qualification
Performance Qualification
References

1. Topic:- Qualification of Fluidized Bed Dryer Subject Name :- Pharmaceutical Validation Subject Code:- MQA204T Department of Pharmaceutical Quality Assurance Smt. B. N. B. Swaminarayan Pharmacy College, Salvav – vapi Presented by:- Machhi Dhruvi A. 2 nd sem M.Pharm .

2. CONTENTS Fluidized Bed Dryer Principle of FBD Construction of FBD Working of FBD Steps of Fluidization Qualification of FBD Design Qualification Installation Qualification Operational Qualification Performance Qualification References 22-05-2022 Dhruvi Anilkumar Machhi 2

3. Fluidized Bed Dryer (FBD) 22-05-2022 Dhruvi Anilkumar Machhi 3 FBD is used for drying of different pharmaceutical materials or products & it can easily achieve specific moisture content in granules & powders. FBD is able to remove excess moisture from different materials & its working principle is so precise & focused on drying the materials without changing their physical attributes.

4. In fluidization process, hot air is introduced at high pressure through a perforated bed of moist solid particulate. The wet solids are lifted from the bottom & suspended in a stream of air (fluidized state). As the hot air passes between the particles it takes the excess moisture from the particles thus drying the particles. Heat transfer is accomplished by direct contact between the wet solid and hot gases. 22-05-2022 Dhruvi Anilkumar Machhi 4 Principle of Fluidized Bed Dryer

5. There is a removable bowl on the side of the stainless steel fluidized bed dryer & the pressure chamber is made of stainless steel. Air handling units, product vessels, exhaust filters, exhaust blowers, control panels, air distribution plates, spray nozzles & solution delivery apparatuses are typical fluidized bed dryer components. A suitable pressure drop across the distributor is necessary to ensure proper fluidization. 22-05-2022 Dhruvi Anilkumar Machhi 5 Construction of Fluidized Bed Dryer

6. Solid powdered material is allowed to flow through an upward stream of air. This causes all particles to move at a faster rate than their setting rate. The air will blow up solid particles & suspend them in the airstream as it passes over them. Hot air can be used to aid in the fluidization of the bed after it has been fluidized. Hot air accelerates the drying process. The air is introduced into the bowl from the bottom & heated to a set temperature by heaters. Filtered air is passed through the bed of the material after it has been filtered. Fans at the top of the equipment are responsible for the constant airflow. Through the use of a control panel, all parameters of the equipment, such as flow rate and temperature, can be adjusted. 22-05-2022 Dhruvi Anilkumar Machhi 6 Working of Fluidized Bed Dryer

7. Steps of Fluidization Step 1: Fluidized bed dryer loading Step 2: Air inlet (intake) Step 3: Fluidization Step 4: Drying Step 6: Filter bag shaking Step 7: Discharging of dried material 22-05-2022 Dhruvi Anilkumar Machhi 7

8. Qualification of Fluidized Bed Dryer FBD control parameters: 22-05-2022 Dhruvi Anilkumar Machhi 8 Fixed Variable (Monitor) Response (Test) Bowl Porosity of filter bags Bowl sieve Inlet/exhaust air temperature Product temperature Drying time Air volume Humidity of incoming air Humidity of exhaust air Particle size distribution Densities Loss on drying Assay

9. Design Qualification It involves the functional & operational specification of dryers; Facility layout Utility requirement i.e. vertical or horizontal Required capacity of the dryer 22-05-2022 Dhruvi Anilkumar Machhi 9

10. Procedure: Check the IQ parameters against their specifications. Utility Installation, Operating Manual Check for any physical damage Verify electrical Supply Inlet Air installation SOP, Mfg. / Supplier Details After checking all the specifications as mentioned in the selection criteria, service engineer of the manufacturer shall be called for commissioning, if necessary. Authorized validation team shall carry out installation. Department Head of production, QA & engineering shall evaluate installation report. 22-05-2022 Dhruvi Anilkumar Machhi 10 Installation Qualification

11. Acceptance Criteria For Installation Qualification: The equipment shall fulfill the selection criteria & its purpose of Application. Name of the manufacturer & supplier shall be as mentioned in the Purchase order. The manufacturer/supplier shall provide complete equipment manual along with the equipment. 22-05-2022 Dhruvi Anilkumar Machhi 11

12. Procedure: Initiate the actual operation of the FBD to ensure that machine is operating within specification. Check the OQ parameters against their specifications. Check Alarm control Speed of Air Moisture content Tap Density Particle Size Distribution Heat Distribution study Observe the functioning of all controls available on control panel. Record the observation. Perform & attach report of heat distribution study as per Heat distribution study procedure. 22-05-2022 Dhruvi Anilkumar Machhi 12 Operational Qualification

13. Acceptance criteria (Heat Distribution Study) : Temperature difference between all thermocouples & set temperature should not differ by more than ± 5 ̊C. All operating inputs provided on the equipment when tested shall successfully comply /meet tolerance limit. The equipment should successfully perform when operated as per SOP. Critical gauges/indicators provided on the equipment should be calibrated. 22-05-2022 Dhruvi Anilkumar Machhi 13

14. Procedure: After completion of OQ initiate the PQ of FBD. Run the trial batch during operation there should not be change in the size, shape, surface characteristics. The effectiveness of drying will be qualified by determining reduction of % moisture content in drying process. 3 batches of any product will be taken for PQ of FBD. At least 2 gm of sample is sampled for % moisture content ;check from the top, middle & bottom trays & it will be reported. In case of any deviation reported, inform to department head for necessary action. Document the deviation details 22-05-2022 Dhruvi Anilkumar Machhi 14 Performance Qualification

15. Acceptance criteria: The reduction in moisture content after drying should be as per the specification in the BMR. % RSD of LOD should not be more than 6 %. The equipment should produce intended outputs with respect to quality & quantity consistently. 22-05-2022 Dhruvi Anilkumar Machhi 15

16. References http://www.slideshare.net/JadhavAnkushJadhav/qualification-of-manufacturing-equipments?from_m_app=android Chandrasekhar Panda, “ Principle and Working of Fluidized Bed Dryer”, https://pharmaceuticalupdates.com/2020/12/27/principle-and-working-of-fluidized-bed-dryer-fbd/ Ankur Choudhary, “ Principle, Construction, Working, Uses, Merits and Demerits of Fluidized bed dryer”. https://www.pharmaguideline.com/2007/02/principle-construction-working-uses-merits-demerits-of-fbd.html?m=1 Subrahmanyam CVS, Setty JT, Sarasija S & Devi VK in “ Pharmaceutical Engineering- Principles & Practices”, Vallabh Prakashan , New Delhi, 2001, 390-391, 397-399. 9. Ankur Choudhary, “ Working and Principle of Tablet Compression Machine”. 22-05-2022 16 Dhruvi Machhi Smt.BNB.SPC, Salvav-Vapi

17. Thank you 22-05-2022 17 Dhruvi Machhi Smt.BNB.SPC, Salvav-Vapi