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Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
© Created & Copyrighted by Shivang Chaudhary
TABLETS MANUFACTURING LINE PROCESS ANALYTICAL TECHNOLOGY FOR DESIGNING, ANALYZING &
CONTROLLING CMAs & CPPs OF TABLET MANUFACTURING LINE
SHIVANG CHAUDHARY
© Copyrighted by Shivang Chaudhary
Formulation Engineer (QbD/PAT System Developer & Implementer) MS (Pharmaceutics)- National Institute of Pharmaceutical Education & Research (NIPER), INDIA
PGD (Patents Law)- National academy of Legal Studies & Research (NALSAR), INDIA
+91 -9904474045, +91-7567297579 [email protected]
https://in.linkedin.com/in/shivangchaudhary
facebook.com/QbD.PAT.Pharmaceutical.Development
Presented by
PAT FOR
© Created & Copyrighted by Shivang Chaudhary
Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
Process Analytical Technology (PAT) A System for- • Designing, • Analysing & • Controlling Manufacturing through Timely Measurements (i.e., during processing) of Critical Quality and Performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. Note: Through PAT, Online Feedback Controlling System for each & individual CMAs &/or CPPs will be developed through designing of controls by analysis at line/ on line/ in line analyser system
What is PAT?
Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
CONTROLLING PHASE
ANALYZING PHASE
DESIGNING PHASE
IDENTIFICATION OF CRITICAL STEPs
SIFTING DRYING GRANULATION SIZING COMPRESSION BLENDING COATING
SIFTER FOR
DELUMPING
RAPID MIXER
GRANULATOR FLUID BED
DRYER
BIN
BLENDER
COMPRESSION
MACHINE
COATING
MACHINE SIFTER CUM
MULTI MILL
A B C D E F G
CRITICAL PROCESSING STEPS
© Created & Copyrighted by Shivang Chaudhary
© Created & Copyrighted by Shivang Chaudhary
Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
SIFTER FOR
DELUMPING
RAPID MIXER
GRANULATOR FLUID BED
DRYER
BIN
BLENDER
COMPRESSION
MACHINE
COATING
MACHINE
TEMPERATURE &
RELATIVE HUMIDITY
At Line
Thermo-hygrometer
GRANULE SIZE DISTRIBUTION
At line Malvern
Particle Size Analyzer OR
On line Sieve Shaker Analysis,
BD-TD Apparatus &
Reposiography
API / EXCIPIENT PURITY
At line UV/ HPLC/ GC,
On line LOD/ HMB or W/KF
API / EXCIPIENT PARTICLE
SIZE DISTRIBUTION
At line Malvern Particle
Size Analyzer OR On Line
Sieve Shaker Analysis
RESIDUAL MOISTURE
CONTENT
On Line LOD
Halogen Moisture Balance or
At Line Water by KF/ GC
BLEND UNIFORMITY
At line UV/HPLC
system; LUBRICATION
analyzed by on line BD-
TD & Reposiography
COMPRESSION
On Line
Weight variation,
Hardness, Friability &
Disintegration Test
Content Uniformity &
Dissolution profiling
analyzed by At line
UV/ HPLC systems
COATING
On Line
Weight variation,
Disintegration test,
CU & Dissolution profiling
by At Line UV/ HPLC;
Color shade variation by
At line Raman Pectrometer
PARTICLE SIZE
DISTRIBUTION
At Line Malvern PSA or
On Line Sieve Shaking
SIFTER CUM
MULTI MILL
Risk Analysis of CMAs & CPPs with respect to CQAs at Raw Scale Developmental level by ON LINE / AT LINE Analyzers for Prediction of Real Time Data &
Designing of Control Strategies at Commercial Scale
CONTROLLING PHASE
ANALYZING PHASE
IDENTIFICATION OF CRITICAL STEPs
DESIGNING PHASE
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF CRITICAL STEPs
Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
TEMPERATURE &
RELATIVE HUMIDITY
In Line
Thermo-hygrometer
GRANULE SIZE DISTRIBUTION
In Line Lasentec FBRM (Focused
Beam Reflectance Measurement)
or
PVM (Particle Video Monitoring)
&
AES (Acoustic Emission
Spectroscopy)
API / EXCIPIENT PURITY
In Line FT-NIR
API / EXCIPIENT PARTICLE
SIZE DISTRIBUTION
In line FBRM
RESIDUAL MOISTURE
CONTENT
In Line Bruker FT-NIR
BLEND UNIFORMITY
In Line FT-NIR
COMPRESSION
In Line Compression Force
Sensor with Servo motor for
Automatic control of
Weight/ Hardness &
Content Uniformity by
In Line FT-NIR
COATING
Color measurement by In
Line UV-Visible spectro
Shade Variation by
In Line Raman Spectro;
Coating Integrity/
thickness by In Line
Terahertz spectroscopy
PARTICLE SIZE
DISTRIBUTION
In Line FBRM
Real Time Data Analysis at Scale UP-Exhibit Manufacturing Scale by IN LINE analyzers with auto-sensors & Real time data comparison with Raw scale data
for Finalization of Control Strategies at Commercial Scale
CONTROLLING PHASE
DESIGNING PHASE
ANALYZING PHASE
SIFTER FOR
DELUMPING
RAPID MIXER
GRANULATOR FLUID BED
DRYER
BIN
BLENDER
COMPRESSION
MACHINE
COATING
MACHINE SIFTER CUM
MULTI MILL
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF CRITICAL STEPs
DESIGNING PHASE
Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
Application of Auto-controllers at real time Manufacturing scale For Continuously attaining Acceptable ranges of CMAs & CPPs with respect to desired CQAs
Auto controlling of
GRANULE SIZE DISTRIBUTION
by adjusting
Impeller Speed
Chopper Speed
Granulation time
Solution spraying rate
Auto controlling of
RESIDUAL MOISTURE CONTENT
by adjusting Inlet air volume
Inlet air temperature
Auto controlling of
BLEND UNIFORMITY
by adjusting
Rotation speed *
Rotation Time =
Number of Revolutions
Auto-controlling of
TABLET WEIGHT &
HARDNESS by Adjusting
Filing Turret speed,
Feed Frame paddle speed
Feeder Fill depth
Pre Compression Force
Main Compression Force
Auto-controlling of
%WEIGHT GAIN/
COATING INTEGRITY
By adjusting
Spray rate per nozzle,
Atomization air pressure,
Pan Rotation Speed,
Inlet air temperature
Auto controlling of
PARTICLE SIZE DISTRIBUTION
by adjusting Milling Speed &
Number of recycles
Auto-controlling of
TEMPERATURE &
RELATIVE HUMIDITY
Air Handling Unit
(AHU)
A DEVELOPED PAT SYSTEM FOR CONTINUOS AUTOMATIC ANALYSING & CONTROLLING MANUFACTURING THROUGH TIMELY MEASUREMENTS OF CQA & CPPs WITH THE ULTIMATE GOAL OF CONSISTANTLY ENSURING FINISHED PRODUCT QUALITY AT REAL TIME COMMERCIAL SCALE
ANALYZING PHASE
CONTROLLING PHASE
SIFTER FOR
DELUMPING
RAPID MIXER
GRANULATOR FLUID BED
DRYER
BIN
BLENDER
COMPRESSION
MACHINE
COATING
MACHINE SIFTER CUM
MULTI MILL
Implementatn of
Control Strategy
PAT &Development
of Feedback Control system
DoE & Development of Design Space
Quality Risk Assessment of
CMAs & CPPs
Determination of CQAs
Definition of QTPP
© Created & Copyrighted by Shivang Chaudhary
WHEN NO ONE IS LOOKING
SHIVANG CHAUDHARY
© Copyrighted by Shivang Chaudhary
Formulation Engineer (QbD/PAT System Developer & Implementer) MS (Pharmaceutics)- National Institute of Pharmaceutical Education & Research (NIPER), INDIA
PGD (Patents Law)- National academy of Legal Studies & Research (NALSAR), INDIA
+91 -9904474045, +91-7567297579 [email protected]
https://in.linkedin.com/in/shivangchaudhary
facebook.com/QbD.PAT.Pharmaceutical.Development
Created & Copyrighted by
QUALITY MEANS DOING IT RIGHT
