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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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