Installation Qualification(IQ)

 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 ± 5°C 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 -if not
 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.