FBD control parameters Fixed Bowl change Porosity of filter bags Bowl sieve Variable (monitor) Inlet/exhaust air

air temperature Product temperature Drying time Air volume Humidity of incoming air Humidity of exhaust air Response (Test) Particle size distribution Densities Loss on drying Assay

Installation Qualification(IQ) Installation Procedure: 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 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 All recommended utilities of recommended capacities are to be provided near the place of installation Revalidation Criteria The equipment shall be revalidated if; Location of the equipment is changed. There is change of spare/parts,major maintenance or breakdown that have a direct effect on the performance of the equipment Conclusion: The equipment shall be considered qualified for installation provided it meets all the parameters mentioned in the acceptance criteria. After receiving installation report, it shall be evaluated & released for operational qualification, provided installation report is evaluated & the equipment is found meeting all parameters of acceptance criteria Operational Qualification (OQ) Training record Before initiating OQ ensure that SOP for Cleaning and operation of FBD is available. Purpose: To train the qualification team for performing OQ

 Procedure Initiate the actual operation of the FBD to ensure that machine is operating within specification. Check the OQ parameters against their specifications. Observe the functioning of all controls available on control panel Record the observation Perform and attach report of heat distribution study as per ` Heat distribution study procedure Acceptance criteria (Heat Distribution Study:) Temperature difference between all thermocouples and 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---calibrated The equipment when operated shall not - produce abnormal sound - show any discrepancy in its smooth operation. Revalidation Criteria: The equipment shall be revalidated if; Location of the equipment is changed. There is change of spare/ parts, major maintenance or breakdown that have a direct effect on the performance of the equipment Critical gauges shall be replaced or corrected At normal revalidation schedule.

Performance Qualification(PQ) To check Heat Distribution by placing 10 thermocouples in geometric pattern with the FBD Shell and empty Product Container without any load to ensure heat distribution in the drying chamber Heat distribution study will be performed at 65 5C for two hour after achieving the temperature on the controlling sensors to ensure proper heat distribution. Procedure After completion of OQ initiate the PQ of FBD. The effectiveness of drying will be qualified by determining reduction of % moisture content in drying process. 3 batches/ lots of any product will be taken for PQ of FBD.

 At least 2.0 gm of sample is sampled for % MC check from the top, middle and bottom trays and will be reported In case of any deviation inform to department head for necessary action Document the deviation details Deviation is acceptable or not will be decided -if yes 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 Revalidation Criteria: The equipment shall be revalidated if; Location of the equipment is changed. There is change of spare/ parts, major maintenance or breakdown that have a direct effect on the performance of the equipment At normal revalidation schedule. Procedure for Drying Efficacy Study in Fluidized bed Dryer: Ensure the cleaning of machine Load the wet mass in the FBD product container Set the process time & outlet temperature and run the FBD. After completion of drying take out FBD bowl and collect the sample At least 2.0 gm of sample is sampled for % MC check from the top, middle and bottom trays and will be reported Sampling Procedure: Ware nose mask, hand gloves before sampling. Label the sample bag with details as Product name, stage, date, time and sign Collect app. 2.0 gms of dried material composite sample in poly bag as per location shown Record the details of analysis. -if not

 1.2 OPERATIONAL QUALIFICATION (OQ)

Ensure machine

operating within specification.

Check the OQ parameters

Observe controls available

Record and Report

Critical parameters tested during OQ Adjustment Inlet air temperature Adjustment Inlet air quantity Adjustment Spray rate Adjustment Atomizing air

Flow rate test The facility is started with a flow rate of 1000 m3/h The air velocity is measured and recorded at three different measuring points. This measurement is then repeated with a flow rate of 3500 m3/h and 6000 m3/h. The values determined at the various measuring points are compared with one another and assessed. TEMPERATURE CONTROL The temperature control is checked without a product with a flow rate of 5000 m3/h, at 50 C, 80 C and 110 C respectively. After the five minute warm-up phase the temperature must settle down to a constant level which is maintained for 10 minutes. The deviations must not be more than 5 C from the preset value.

Atomizing air Testing conditions: 1.0; 1.5; 2.0; 2.5 bar Testing time: 15 min Specification: fluctuation: 10 %

SPRAYING RATE It is started with a flow rate of 2000 m3/h without heating and without product. The spray medium to be used is water. Measurements must be carried out for 10 minutes with the minimum, with 50% and with the maximum spray rates respectively. The spray quantity is determined by weighing. The trial must be carried out three times for each spray rate which must not deviate by more than 5%. INLET AIR TEMPERATURE Testing conditions: 35C, 55C and 75C at two flows (1500 and 3500 m3/h) Testing time: 30 min Specification: lag time: max.~15 min fluctuation: 2C INLET AIR QUANTITY Testing conditions: 1000; 1500; 2500 and 3500 m3/h long-term stability: 30 min short-term stability: 10 min Specification: fluctuation: 450 m3/h 1.3 PERFORMANCE QUAIFICATION (PQ) 1,2 HEAT DISTRIBUTION To check the heat distribution, must be started with a flow rate of 3000 m3/h without a product load. The temperature is set at 50 C. Following a five minute warm-up phase, the temperature is measured at five different points above the sieve screen for 10 minutes. None of the measured values may deviate by more than 5 C from the average value determined above the screen. The trial is repeated at 80 C and 110 C. The effectiveness of drying will be qualified by determining reduction of % moisture content in drying process. 3 batches/ lots of any product will be taken for PQ of FBD.

 At least 2.0 gm of sample is sampled for % MC check from the top, middle and bottom trays and will be reported. 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 % DRYING EFFICIENCY

Load wet mass

Set Time and Temperature Run the FBD After completation collect sample Check % MC (Moiture content)
Sampling Procedure Ware nose mask, hand gloves before sampling. Label the sample bag with details as Product name, stage, date, time and sign. Collect app. 2.0 gms of dried material composite sample in poly bag as per location shown. Record the details of analysis.