1. EQUIPMENT VALIDATION
EQUIPMENT VALIDATION OF
OF FLUIDISED BED DRYER
FLUDIZED BED DRYER
PRESENTED BY:
PRIYANKA ODELA.
M PHARM
DEPARTMENT OF PHARMACEUTICS

2. CONTENTS
• Introduction.
• Construction of Fluidized Bed Dryer (FBD).
• Working of FBD.
• Validation of FBD.
 Design Qualification (DQ).
 Installation Qualification (IQ).
 Operational Qualification (OQ).
 Performance Qualification (PQ).
• Validation report.
• Bibliography

3. Introduction
 Fluid bed drying is most widely used technique for drying pharmaceutical
powders and granulation.
 The direct contact between particles and air/gas is possible in fluid bed
system.
 Here any type of inert gas or air is used.
 They can be designed in either batch or continuous type fluid bed dryer.
PRINCIPLE
 In fluidized bed dryer, hot air is passed at high pressure through a perforated
bottom of the container containing granules to be dried.
 The granules are lifted from the bottom and suspended in the stream of air.
 This condition is called fluidized state.

4.  The hot gas surrounding every granule to completely dry them.
 Thus, material or granules are uniformly dried.
 The hot air/gas used for drying can be generated by either steam coils or a
combustion furnace.
 In fluid bed drying uniform conditions of temperature, composition and
particle size distribution is achieved throughout the bed because of complete
mixing between the solids and gas is obtained.

5. FLUDISED BED DRYER:

6. CONSTRUCTION:
The construction of a vertical fluidised bed dryer
 The dryer is made of stainless steel or plastic.
 A detachable bowl is placed at the bottom of the dryer, which is used for
charging and discharging.
 The bowl has a perforated bottom with a wire mesh support for placing
materials to be dried.
 A fan is mounted in the upper part for circulating hot air.
 Fresh air inlet, prefilter and heat exchanger are connected serially to heat the
air to the required temperatures.
 The temperature of hot air and exit are monitored.
 Bag filters are placed above the drying bowl for recovery of fines.

7. ADVANTAGES
1) It requires less time to complete drying i.e.,20 to 40 mins compared
2)To 24 hrs of tray dryer. Handling time is also short. It is 15 times faster than
tray dryer.
3)Hot spots are not observed in the dryer, because of its excellent mixing and
drying capacities.
4)It facilitates the drying of thermo labile substances, since the contact time is
short.
5)It can be used either as batch type or continuous type.
6)The free movement of individual particles eliminates the risk of soluble
material migrating as may occur in static bed.

8. DISADVANTAGES:
1) Many organic powders develop electrostatic charges during
drying which can be avoided by efficient electrical earthing of
the dryer.
2) The turbulence of the fluidized state of granules may cause
attrition of some materials resulting in production of fines
which can be avoided by using suitable binding agent.

9. VALIDATION:
• The proof of validation is obtained through the collection and evaluation of
data .
• Beginning from the process development phase and continued through in to
the production phase.
• Validation is necessarily includes process qualification, material, equipment,
system, personnel.
• quoted as………………..
“Validation is not a destination,
It is a never Ending Journey…………..
Life is like a process, If u don’t validate it,
U can’t become a good person.

10. DEFINITION:
• European definition
• European Commission:
• 1991 -“Validation -Act of proving in accordance of GMPs that
any... Process... actually leads to expected results
• US Definition
• US Food and Drug Administration, 1987“Process Validation
is establishing documented evidence which provides a high
degree of assurance that a specified process will consistently
produce a product meeting its pre-determined specifications
and quality characteristics.”

11. Validation Plan
• A Validation plan includes
Validation Phases
Validation Protocols
Appropriate Validation Equipment
Specified Validation Studies

12. Validation Protocol
• A Validation Protocol is an approved document which
summarises the program to be carried out, the tests to
be done and the acceptance criteria for those tests.
Validation Phases:
DQ- Design Qualification
IQ- Installation Qualification
OQ-Operational Qualification
PQ- Performance Qualification

13. Design Qualification:
• Design qualification defines the functional and operational
specifications of the instrument and details for the conscious
decisions in the selection of the supplier.
• The steps that should be considered for inclusion in a design
qualification :
 Description of analysis problem.
 Description of the intended use of the equipment.
 Description of the intended decision.

14.  Preliminary selection of the functional and performance
specifications.
 Preliminary selection of the supplier.
 Final selection of the equipment.
 Final selection of the supplier.
 Development and documentation of final functional and
operational specifications.

15. Installation qualification (IQ)
Installation qualification establishes that the instrument is received as designed and specified, that it
is properly installed in the selected environment, and that this environment is suitable for the
operation and use of the instrument.
• The qualification involves the co-ordinated efforts of :
 The vendor
 The operating department.
 The project team (which provide input into the purchase, installation, operation and
maintenance of the equipment).
• Description of equipment/system including physical characteristics and function of key
components.
• List of manufacturer’s specifications, drawings and operating manuals.
• Verifying proper installation of utilities; water, steam, electrical, compressed air, ventilation,
etc.
• Calibration records for all instrumentation.

16. Operational qualification (OQ)
• Operational qualification is the process of demonstrating that an instrument
will function according to its operational specification in the selected
environment.
• The proper operation of equipment is verified by performing the test
functions specified in the protocol.
• A conclusion is drawn regarding the operation of equipment after the test
functions are checked and all data has been analyzed.
• Verifies correct operation of critical components and operating ranges as
defined by the specification and required performance.
– Control System, Instruments, Mechanical Features
• Operational Tests
– Empty Chamber Mapping
– Component Operation

17. Performance qualification (PQ)
Performance qualification is the process of demonstrating that an instrument consistently
performs according to a specification appropriate for its routine use.
• PQ should always be performed under conditions that are similar to routine sample
analysis.
• PQ should be performed on a daily basis or whenever the equipment is being used.
• In practice, PQ can mean system suitability testing, where critical key system
performance characteristics are measured and are often compared with documented.
• Tests to demonstrate that the equipment/system performs in an actu
– Distribution Studies
– Container Mapping
– Heat Penetration Studies
– Microbiological Challenge Studies

18. FBD DESIGN QUALIFICATION:
• The goal is to perform something similar to a risk analysis and to check the
design documents of a technical system to ensure that then fulfils the user
requirements.
• In fluidized bed dryer the design of the instrument should be:
 Should occupy small place
 Based on our requirement we can go for horizontal or vertical.
 The bed which contain the material should be dried in conical shape or
less some particles may retain as such at the corners
 All technical considerations should be kept in mind while doing the design.

19. Installation Qualification (IQ)
Installation Qualification for fluidized bed dryer include the following steps:
 Verifying the approved purchase order.
 Check the manufacturer and supplier.
 Check for any physical damage.
 Verify that the utilities required are available.
 User manual
 Maintenance manual.
 List of charge parts.
 Electrical drawings.
Specially for FBD:
 Air temperature distribution.
 Inlet air installation
 Microbiological quality of the inlet air.
 Influence on weather on inlet air conditions.

20. Operational Qualification (OQ)
• Documented verification that the system performs as intended throughout all
anticipated operating ranges. Some of them include:
• Verify alarm control.
• Verify that all switches and push button are functioning properly.
• Heat should distributed equally through out the system.
• Do the tests for uniform distribution of air.
• Establish training program for relevant stages.
• Operate all parts at their low, medium, and high levels.
Run three batches of each product and analyze for:
 Speed of air (velocity of air).
 Active ingredients homogeneity.
 Moisture content.
 Particle size distribution.
 Percentage fines.
 Tap density.
Based on this data we can fix drying end points for each process.

21. Performance Qualification (PQ)
PQ means to check what we want actually for that particular process from the
equipment,what processes are to be monitored.
i. Inlet air speed.
ii. Quality of air.
iii. Uniform distribution of air.
iv. Mixing of air with temperature.
Run the trail batch during operation and there should not be any change in
the
 Size
 Shape.
 Surface characteristics.

22. Validation Report
Standard format
1. Executive summary
2. Discussion
3. Conclusions & recommendation
4. List of attachment
 Topic should be presented in the order in which they appear
in the protocol.
 Protocol deviation are fully explained & justified.
 The report is signed & dated by designated representatives
of each unit involved.

23. BIBLIOGRAPHY:
 Guidelines on the Validation of Manufacturing Process, WHO,
1996.
 Development Pharmaceutics and Process Validation, CPMP,
1988.
 R.A.Nash and A.H.Wachter, “pharmaceutical process
validation” third edition, revised and expanded.