SEMINARON

FLUIDIZED BED

DRYER

Presented by

SHEKHAR CHAUDHARY

M.Pharmacy (II sem)

Dept of Quality assurance

CONTENTS

Introduction.

Construction of Fluidized Bed Dryer (FBD).

Advantages of FBD.

Parameters.

Validation Protocol.

Design Qualification (DQ).

Installation Qualification (IQ).

Operational Qualification (OQ).

Performance Qualification (PQ).

Conclusion.

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INTRODUCTION

Fluid bed drying is most widely used technique for drying

Pharmaceutical powders , granules and slurries

Fluid bed processing involves drying, mixing, granulation,

and coating of particulate materials.

In fluid bed drying, heat is supplied by the fluidization gas,

but the gas flow need not be the only source. Heat may be

effectively introduced by heating surfaces (panels or tubes)

immersed in the fluidized layer.

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contd…

The direct contact between particles and air/gas is possible in

fluid bed system.

Fluid bed drying is suited for powders, granules,

agglomerates, and pellets with an average particle size

normally between 50 to 5,000 microns. Very fine, light

powders or highly elongated particles may require vibration

for successful fluid bed drying.

Materials with moisture content up to 80% such as some

polymers, dye stuffs and molecular sieve catalysts can also be

accommodated.4

CONSTRUCTION

The dryer is made up of stainless steel or plastic.

It consist of a hollow vertical chamber where dry, heated air

enters through the bottom of the chamber and exhaust air exits

through the top of the chamber.

A detachable bowl is placed at the bottom of the dryer, which

is used for charging and discharging of material.

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The bowl has a perforated bottom with a wire mesh support

for placing materials to be dried and to diffuse the upward

flowing air which helps to create a stable and uniform

fluidized bed.

A fan is mounted in the upper part for circulating hot air.

Fresh air inlet, pre-filter and heat exchanger are connected

serially to heat the air to the required temperature.

Bag filters are placed above the drying bowl for the recovery

of fines.

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Drying of granules in FBD

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ADVANTAGES OF FBD:

Fluidized bed dryer requires less time to complete

drying. i.e., 20 to 40 min.

Hot spots are not observed in the dryer, because of its

excellent mixing and drying capacities.

The thermal efficiency is 2 to 6 times greater than tray

dryer.

It facilitates the drying of thermolabile substances , since

the contact time for drying is short.

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Parameters

Fixed parameters:

Porosity of filter bags,

Bowl sieve.

Variable ( to be monitored):

Inlet/exhaust air temperature,

Product temperature,

Drying time,

Air volume,

Humidity of incoming air and exhaust air.

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VALIDATION

“ Establishing documented evidence that provides a high degree of

assurance that a specific process will consistently produce a product

meeting its predetermined specifications and quality attributes.”

Validation applies to processes or analytical methods.

Validation provides an approach to prove quality, functionality and

performance of a pharmaceutical/biotechnological manufacturing process.

This approach can be applied to individual pieces of equipment as well as

the manufacturing process as a whole

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Equipment Validation protocol

Equipment

Validation

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Installation

Qualification (IQ)

Operational

Qualification (OQ)

Performance

Qualification (PQ)

Design

Qualification (DQ)

DESIGN QUALIFICATION

Documented verification that the proposed design of

equipment/systems is suitable for the intended purpose.

Requirements are best created before “shopping” is

undertaken.

Requirements are created by the needs of the system/process

of which the equipment/system will be a part.

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INSTALLATION QUALIFICATION

“Assurance that the intended equipment is received as

designed and specified”.

Verifying proper installation of utilities; water, steam,

electrical, compressed air, ventilation, etc.

Instruments for measuring temperature, humidity, time, air

volume , pressure as well as recording devices for these

variables should be calibrated.

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Installation Qualification for fluidized bed dryer include the

following steps:

Verifying the approved purchase order.

Verify model number, serial number.

Ensure that all relevant documentation is received:

User manual,

Maintenance manual,

List of change parts,

Electrical drawings. 15

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Check the manufacturer and supplier.

Check for any physical damage.

Confirm location and installation requirements per

recommendation of manufacturer.

Verify that the utilities required are available.

Dust free area and moisture free air should be provided.

Installation shall be conducted per instructions provided in the

manual.

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OPERATIONAL QUALIFICATION

The documented evidence that the system or equipment

performs as intended throughout all anticipated operating

ranges.

“Confirmation that the equipment functions as specified and

operates correctly”.

Verifies correct operation of critical components and operating

ranges as defined by the specification and required

performance.

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Verify alarm control.

Operate the equipment at low, medium, and high speed per

operations manual to verify the operating control.

Verify that all switches and push buttons are functioning

properly.

Establish procedures for operation, maintenance, and

calibration.

Establish training program for relevant staff.

All the electrical fittings in the room must conform to ISI

specifications of Flameproof Electrical fittings.

Do the tests for uniform distribution of air.

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Run three batches of each product and analyze for:

Active ingredients homogeneity.

Moisture content.

Particle size distribution.

Percentage fines.

Based on this data we can fix drying end points for

each process.

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Specially for FBD:

i. Air temperature distribution: Using thermocouples.

ii. Inlet air installation:

a) Delay time for achieving constant air conditions: Using

thermocouple and hygrometer.

b) Microbiological quality of the inlet air: Using centrifugal

air sampler.

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PERFORMANCE QUALIFICATION

The documented evidence that the system, equipment or

process is capable of consistently producing a safe product of

high quality.

Tests to demonstrate that the equipment/system performs in an

actual as-used scenario.

Heat Distribution Studies

Heat Penetration Studies

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It is check up of what we want actually for that particular

process from the equipment.

i. Inlet air speed.

ii. Quality of air.

iii. Uniform distribution of air.

iv. Mixing of air with temperature.

Run the trial batch during operation and there should not be any

change in the:

1. Size, 2. Shape , 3.Surface characteristics of the material

which we kept for drying.

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Conclusion

Validation provides an approach to prove

quality, functionality and performance of a

pharmaceutical/biotechnological manufacturing

process.

Each time before use of the equipment it

should be calibrated and maintained and

proper precautions should be taken to increase

the life span of the equipment.

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