"pat" for 'soft gelatin capsule
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
SOFTGEL CAPSULE MANUFACTURING PROCESS ANALYTICAL TECHNOLOGY FOR DESIGNING, ANALYZING & CONTROLLING
CMAs & CPPs OF SOFTGEL 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
© Created & Copyrighted by Shivang Chaudhary
MEDICINE HOPPER
LUBRICATION
ROLLERS
SPREADER
BOX
MEDICINE PUMP
LUBRICATION
ROLLERS
DIE
ROLLER
DIE
ROLLER
INJECTION
WEDGE
SPREADER
BOX
COOLING
DRUM
COOLING
DRUM
CONVEYER ROLL
ME
LT
ING
JA
CK
ET
ME
LT
ING
JA
CK
ET
COOLING
FAN
COOLING
FAN
GELATIN
MIXER /MELTER
GELATIN PREPARATION DRUG MATERIAL
PREPARATION A
D
B
C
E
F
G
CRITICAL PROCESSING STEPS
METERING OF DRUG MATERIAL
RIBBON CUTTING
CAPSULE SEALING
NAPHTHA BATH WASHING
1 ° FLUID BED TUNNEL & 2° TRAY DRYING
SPREADING OF GELATIN
COOILING OF RIBBON
H
I
© 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
MEDICINE HOPPER
LUBRICATION
ROLLERS
SPREADER
BOX
MEDICINE PUMP
LUBRICATION
ROLLERS
DIE
ROLLER
DIE
ROLLER
INJECTION
WEDGE
SPREADER
BOX
COOLING
DRUM
COOLING
DRUM
CONVEYER ROLL
ME
LT
ING
JA
CK
ET
ME
LT
ING
JA
CK
ET
COOLING
FAN
COOLING
FAN
GELATIN
MIXER /MELTER
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
HOMOGENEITY off FILL
analyzed by At line
UV/ HPLC system
CAPSULE FILL WEIGHT by
On Line Weight Variation &
Disintegration Testing
ONLINE VISUAL INSPECTION
for cleaning, polishing &
sorting of unfilled/ half
filled/ defective capsules
ONLINE GROUP
WEIGHT
CHECKING of
Filled Capsules
MOISTURE CONTENT of
GEL MASS by At line
Toluene Distillation
Method
RIBBON THICKNESS
by On line Digital Stage
Microscopy & Calipers
SEAL THICKNESS
by On line Digital Stage
Microscopy & Calipers
VISCOSITY of GEL MASS
by On line Brookfield
Viscometer SPECIFIC GRAVITY
Of fill material analyzed by
online Sp. Gravity bottle
RESIDUAL MOISTURE OF
FILLED CAPSULES
by At line Toluene
Distillation Method
© 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
MEDICINE HOPPER
LUBRICATION
ROLLERS
SPREADER
BOX
MEDICINE PUMP
LUBRICATION
ROLLERS
DIE
ROLLER
DIE
ROLLER
INJECTION
WEDGE
SPREADER
BOX
COOLING
DRUM
COOLING
DRUM
CONVEYER ROLL
ME
LT
ING
JA
CK
ET
ME
LT
ING
JA
CK
ET
COOLING
FAN
COOLING
FAN
GELATIN
MIXER /MELTER
CONTENT UNIFORMITY
analyzed by In Line Bruker FT-NIR
TEMPERATURE &
RELATIVE HUMIDITY
by In Line Thermo-
hygrometer
API / EXCIPIENT PURITY
analyzed by
In line Bruker FT-NIR
API / EXCIPIENT PARTICLE
SIZE DISTRIBUTION
analyzed by In line
Lasentec Focused Beam
Reflectance Measurement
(FBRM)
HOMOGENEITY off FILL
analyzed by In Line
Bruketr FT_NIR
CAPSULE FILL WEIGHT
by In line Check Weigher
based on Gravimetric
EMFR System
DIAMETER SORTER for inline
sorting of under/ overfill capsules
MOISTURE CONTENT of
GEL MASS by Inline Bruker/
MT FT_NIR System
RIBBON THICKNESS
by In line Digital HD
Microscopy & Video
Monitoring
SEAL THICKNESS
by In line Digital HD
Microscopy & Video
Monitoring
VISCOSITY of GEL MASS
by In line Viscometer
SPECIFIC GRAVITY
Of FILL MATERIAL
analyzed by inline
hydrometer
SPECIFIC GRAVITY
Of GEL MASS analyzed by
inline hydrometer
COLOR SORTER for inline sorting of
defective capsules with air bubbles
RESIDUAL MOISTURE OF
FILLED CAPSULES by In line
Bruker FT-NIR
© 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
MEDICINE HOPPER
LUBRICATION
ROLLERS
SPREADER
BOX
MEDICINE PUMP
LUBRICATION
ROLLERS
DIE
ROLLER
DIE
ROLLER
INJECTION
WEDGE
SPREADER
BOX
COOLING
DRUM
COOLING
DRUM
CONVEYER ROLL
ME
LT
ING
JA
CK
ET
ME
LT
ING
JA
CK
ET
COOLING
FAN
COOLING
FAN
GELATIN
MIXER /MELTER
Auto-controlling of
TEMPERATURE &
RELATIVE HUMIDITY
Air Handling Unit
(AHU)
Auto Controlling of
HOMOGENEITY off FILL
By adjusting Homogenizer
Mixing Speed &
Mixing Time
Auto-controlling of
FILLED CAPSULE WEIGHT &
by adjusting
Die Roller Speed,
Rotating Drum Speed
Auto Controlling of
RIBBON THICKNESS
by adjusting Gap between
spreader box & rotating
cooling drum
Auto controlling of
SEAL THICKNESS
by adjusting Gap
between Die Rollers
Auto-controlling of
RESIDUAL MOISTURE
by adjusting
Drying Temperature
Drying Time
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