VALIDATION OF FLUIDIZIED BED DRYER

Content:

Why to validate?Parts of Equipment ValidationWho should do Equipment Validation?Equipment qualificationTypical process flow of solid dosage formValidation of fluid bed dryer

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Why to validate?

Equipment validation is Vital for • Safety • Fewer interruptions of work • Lower repair costs • Elimination of premature replacement • Less standby equipment • Identification of high maintenance cost • Reduction of variation in results • Greater confidence in the reliability of results 3

Parts of Equipment Validation

EquipmentValidationEquipmentValidation

Installation Qualification (IQ)

Installation Qualification (IQ)

Operational Qualification (OQ) 

Operational Qualification (OQ) 

Performance Qualification (PQ)

Performance Qualification (PQ)

Design Qualification (DQ)

Design Qualification (DQ)

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Who should do Equipment Validation? The vendor or the user?

The user has the ultimate responsibility for equipment qualification.

DQ should always be done by the user.While IQ for a small and low cost instrument is

usually done by the user, and IQ for large, complex and high cost instruments

should be done by the vendor.OQ can be done by either the user or the vendor.PQ should always be done by the user 5

Equipment qualification

Equipment qualification / validation includes following things :

• Design qualification (DQ)• Installation qualification (IQ)• Operational qualification (OQ)• Performance qualification (PQ)

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Typical process flow of solid dosage form

Addition of raw material-active excipients

Preble bending-high speed mixer granulator

Granulating - high speed mixer granulator

Drying -fluid bed dryer-tray dryer

Tableting -high speed

rotary

Blending -v-blender

Addition of raw material-lubricant-disintegrants

Sizing -mill/sieve

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Typical variable of drying process

Control variable

Initial temperature Load sizeDrying temperature programAir flow programDrying timeCooling time

Measured responses

Density Yield Moisture content

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VALIDATION

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fluid bed dryer

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FBD control parameters

Fixed Variable(monitor)

Response (Test)

Bowl changePorosity of filter bagsBowl sieve

Inlet/exhaust air temperatureProduct temperatureDrying timeAir volumeHumidity of incoming air Humidity of exhaust air

Particle size distributionDensitiesLoss on dryingAssay

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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

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Conti…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 orderThe manufacturer/supplier shall provide complete

equipment manual along with the equipmentAll recommended utilities of recommended

capacities are to be provided near the place of installation 13

Conti…

Revalidation CriteriaThe 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

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Conti…

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

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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

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Conti…ProcedureInitiate 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 panelRecord the observation Perform and attach report of heat distribution

study as per ` Heat distribution study procedure’ 17

Conti…

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 limitThe equipment should successfully perform when

operated as per SOP18

Conti…

Critical gauges/indicators provided on the equipment---calibrated

The equipment when operated shall not - produce abnormal sound - show any discrepancy in its smooth operation.

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Conti…

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 correctedAt normal revalidation schedule.

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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.

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Conti…

ProcedureAfter 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 22

Conti…

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

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Conti…

Acceptance criteriaThe 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

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Conti…

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.

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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 sampleAt least 2.0 gm of sample is sampled for % MC

check from the top, middle and bottom trays and will be reported

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Conti…

Sampling Procedure:Ware nose mask, hand gloves before sampling.Label the sample bag with details as Product

name, stage, date, time and signCollect app. 2.0 gms of dried material composite

sample in poly bag as per location shownRecord the details of analysis.

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