"pat" for 'hard gelatin capsule' manufacturing line
TRANSCRIPT
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
HARD GELATIN CAPSULE MANUFACTURING PROCESS ANALYTICAL TECHNOLOGY FOR DESIGNING, ANALYZING & CONTROLLING
CMAs & CPPs OF HARDGEL CAPSULE 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
PAT For
HARD GELATIN CAPSULE MANUFACTURING (Contd…)
© Created & Copyrighted by Shivang Chaudhary
EMPTY CAPSULE
SHELL ELEVATOR
AUTOMATIC CAPSULE
SHELL CONVEYING
SYSTEM
INLINE WEIGH
CHECKING SYSTEM
INLINE METAL
DETECTOR SYSTEM
MINI CAPSULE
SORTER
EMPTY CAPSULE
ELIMINATOR by
VACCUM
FILLING STATION
BY TAMPING /
DOSATOR SYSTEM
BIN BLENDER
FOR PRODUCT
MIXING
AUTOMATIC
PRODUCT
ELEVATOR SYSTEM
CAPSULE ORIENTS &
CAP/ BODY SEPARATES
BY VACUUM SYSTEM
CAPSULE READY
FOR PACKING
DEDUSTING &
POLISHING
SYSTEM
AUTOMATIC
PRODUCT
CONVEYING SYSTEM
AUTOMATIC
CAPSULE FILLING
MACHINE
AIR DISPLACEMENT
UNIT
DRY MIXING
SEPARATION OF CAP FROM BODY
LOADING OF EMPTY CAPSULES
FILLING OF CAPSULES
DE DUSTING
CLOSING OF CAPSULES
CLEANING & POLISHING
A B C D E F G
CRITICAL PROCESSING STEPS
SORTING
H
© 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
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
TEMPERATURE &
RELATIVE HUMIDITY
by At Line Thermo-
hygrometer
API / EXCIPIENT PURITY
analyzed by
At line UV/ HPLC/ GC,
On line LOD/ HMB or W/KF
API / EXCIPIENT PARTICLE
SIZE DISTRIBUTION
analyzed by At line Malvern
Particle Size Analyzer
OR On Line
Sieve Shaker Analysis
BLENDING &
LUBRICATION
Blend Uniformity
analyzed by At line
UV/HPLC system
CAPSULE FILLING
On Line Weight Variation &
Disintegration Testing
ONLINE METAL
DETECTOR SYSTEM
ONLINE VISUAL INSPECTION
FOR DEDUSTING, POLISHING
& SORTING OF UNFILLED/
DEFECTIVE CAPSULES
ONLINE GROUP
WEIGHT
CHECKING of
Filled Capsules
CAPSULE READY
FOR PACKING
ONLINE GROUP
WEIGHT
CHECKING of
Empty Capsules
MOISTURE CONTENT of
EMPTY CAPSULE SHELLS by
On line Halogen Moisture
Balance or At line
Water by KF
PAT For
HARD GELATIN CAPSULE MANUFACTURING (Contd…)
© 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
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
WEIGHT VARIATION
of Filled Capsules
by In line
Check Weigher
based on Gravimetric
EMFR System
INLINE METAL
DETECTOR SYSTEM
IN LINE MINI
CAPSULE
SORTER
IN LINE
EMPTY CAPSULE
ELIMINATOR by
VACCUM
TEMPERATURE &
RELATIVE HUMIDITY
by In Line Thermo-
hygrometer
IN LINE
DEDUSTING &
POLISHING
SYSTEM
API / EXCIPIENT PURITY
analyzed by In line
Bruker FT NIR
API / EXCIPIENT PARTICLE
SIZE DISTRIBUTION
by In Line Lasentec
Focused Beam Reflectance
Measurement (FBRM)
CONTENT UNIFORMITY
analyzed by In Line Bruker FT-NIR BLEND UNIFORMITY
analyzed by In line
Bruker FT-NIR
WEIGHT VARIATION
of Empty Capsules
Shells by In line
Check Weigher
based on Gravimetric
EMFR System
MOISTURE CONTENT
OF EMPTY CAPSULE SHELLS
by Inline Bruker/ MT
FT_NIR System
CAPSULE READY
FOR PACKING
PAT For
HARD GELATIN CAPSULE MANUFACTURING (Contd…)
© 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
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
INLINE WEIGHT
CHECKING SYSTEM
auto controlling
Turret Speed of
Filled Capsules
IN LINE MINI
CAPSULE
SORTER
IN LINE EMPTY
CAPSULE
ELIMINATOR
by VACCUM
CAPSULE READY
FOR PACKING
Auto-controlling of
TEMPERATURE &
RELATIVE HUMIDITY
Air Handling Unit
(AHU)
IN LINE
DEDUSTING &
POLISHING
SYSTEM
Auto controlling of
BLEND UNIFORMITY
by adjusting
Rotation Speed *
Rotation Time =
Number of Revolutions
Auto-controlling of
FILLED CAPSULE WEIGHT &
PLUG HARDNESS by adjusting
Filing Turret Speed,
Feed Frame Paddle speed
Tamping Force, Dosator
Piston Stroke Volume
INLINE METAL
DETECTOR SYSTEM
Auto controlling
ON/OFF System of
Machine
Auto Controlling of
EMPTY CAPSULE
SHELL WEIGHT by
adjusting Feeder
Speed for Empty
Capsule shells
PAT For
HARD GELATIN CAPSULE MANUFACTURING (Contd…)
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
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QUALITY MEANS DOING IT RIGHT