3. Introduction:
Fluidized bed dryer (FBD) is well known and widely used equipment in the pharmaceutical
manufacturing .
The direct contact between particles and air is possible in fluid bed system
It is used in granulation process for drying the material to get desired moisture content in the
granules required for perfect compression of tablet formulation.
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4. Principle
The main principle involved in fluidized bed dryer is
FLUIDIZATION
1. Hot air is passed at high speed through a perforated bottom of the container
containing granules
2. The granules are lifted from the bottom and suspended in the stream of air this
condition is called βfluidized stateβ.
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5. CONSTRUCTION:
1. Made up of stainless steel
2. Detachable bowl
3. Fan
4. Fresh air inlet, heat exchanger
5. Bag filter
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10. ADVANTAGES:
1. High rates of moisture removal
2. Low capital and maintenance cost
3. Highly efficient in material drying
4. Handling is easy
5. Wide range
6. No hot spot on the product
7. Suitable for both
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11. DIS-ADVANTAGES:
1. Poor fluidization and low flexibility
2. Not the best choice of equipment
3. Entertainment of fine particles
4. Product loss
5. Sticky material is quite difficult
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12. Application:
1. Drying of the granules in the production of the tablet
2. Coating of the tablet
3. Agriculture , pharma, food ,dairy
4. Polymer film coating
5. Drying moist (DCPA)
6. Top spray granulators
7. Formulation , development and production
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13. VALIDATIONprotocol:
A Validation Protocol is an approved document which outlines the program to be employed,
the tests that will be made and the acceptance criteria for those tests.
Validation Phases:
DQ- Design Qualification
IQ- Installation Qualification
OQ-Operational Qualification
PQ- Performance Qualification
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14. DESIGNQUALIFICATION
In fluidized bed dryer the design of the instrument should be:
occupy the small place.
Based on our requirement we can go for horizontal or vertical.
kept in mind while doing the design.
Every fluid bed dryer must have explosion relief device .
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15. INSTALLATIONQUALIFICATION:
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β’ Verifying the approved purchase order
model number, serial number
β’ Ensure all documentation is received
β’ Check the manufacturer and supplier.
β’ Check for any physical damage.
β’ Confirm location and installation
β’ Dust free area and moisture free air
should be provided.
β’ Installation shall be conducted per
instructions provided in the manual.
16. OPERATIONALQUALIFICATION:
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β’ Verify alarm control.
β’ Operate the equipment at
low, medium, and high
speed
β’ Verify that all switches
and push buttons are
functioning properly.
β’ procedures
β’ training program
β’ electrical fittings