This document discusses fluidized bed dryers (FBDs) used in pharmaceutical manufacturing. It provides information on:
1) The principle of fluidization where hot air is passed through granules in a container, lifting and suspending them in a "fluidized state" for drying.
2) The construction of FBDs using stainless steel with a detachable bowl, fan, filters and air inlets/outlets.
3) The working where granules are placed in the dryer and hot air flows through them to achieve drying before the air exits.
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
• Hot air is passed at high speed through a perforated bottom of the container
containing granules
• The granules are lifted from the bottom and suspended in the stream of air this
condition is called “fluidized state”.
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5. CONSTRUCTION:
• Made up of stainless steel
• Detachable bowl
• Fan
• Fresh air inlet, heat exchanger
• Bag filter
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10. ADVANTAGES:
• High rates of moisture removal
• Low capital and maintenance cost
• Highly efficient in material drying
• Handling is easy
• Wide range
• No hot spot on the product
• Suitable for both
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11. DIS-ADVANTAGES:
• Poor fluidization and low flexibility
• Not the best choice of equipment
• Entertainment of fine particles
• Product loss
• Sticky material is quite difficult
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12. Application:
• Drying of the granules in the production of the tablet
• Coating of the tablet
• Agriculture , pharma, food ,dairy
• Polymer film coating
• Drying moist (DCPA)
• Top spray granulators
• Formulation , development and production
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13. VALIDATION protocol:
• 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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• Verifying the approved purchase order
model number, serial number
• Ensure all documentation is received
• Check the manufacturer and supplier.
• Check for any physical damage.
• Confirm location and installation
• Dust free area and moisture free air
should be provided.
• Installation shall be conducted per
instructions provided in the manual.
16. OPERATIONAL QUALIFICATION:
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• Verify alarm control.
• Operate the equipment at
low, medium, and high
speed
• Verify that all switches
and push buttons are
functioning properly.
• procedures
• training program
• electrical fittings
17. PERFORMANCE QUALIFICATION:
• Run the trial batch during the:
• 1. Size
• 2. Shape
• 3.Surface of the material which we kept for drying.
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18. MAKERS OF FBD:
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• Tapasya Engineering
works Pvt Ltd.
• Chitra Machineries
Pvt Ltd.
• NU Pharma
Engineers And
Consultant.
• Chamunda Pharma
Machinery Pvt. Ltd.