Definition of
QTPP
PAT FOR
SOFTGEL CAPSULE MANUFACTURING Determination of
PROCESS ANALYTICAL TECHNOLOGY FOR DESIGNING, ANALYZING & CONTROLLING CMAs & CPPs OF SOFTGEL CAPSULE MANUFACTURING LINE
CQAs
Quality Risk Assessment of
CMAs & CPPs
DoE
& Development of Design Space
PAT
&Development of Feedback Control system
Presented 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
Implementatn of
Control Strategy
facebook.com/QbD.PAT.Pharmaceutical.Development https://in.linkedin.com/in/shivangchaudhary +91 -9904474045, +91-7567297579
© Copyrighted by Shivang Chaudhary
[email protected]
© Created & Copyrighted by Shivang Chaudhary
What is PAT? Definition of
QTPP
Determination of
CQAs
Process Analytical Technology (PAT) Quality Risk Assessment of
CMAs & CPPs
DoE
& Development of Design Space
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.
PAT
&Development of Feedback Control system
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
Implementatn of
Control Strategy
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF CRITICAL STEPs
DESIGNING PHASE
ANALYZING PHASE
CONTROLLING PHASE
Definition of
QTPP GELATIN MIXER /MELTER
MEDICINE HOPPER MEDICINE PUMP
Determination of
CQAs A
GELATIN PREPARATION
D
DRUG MATERIAL PREPARATION
E
METERING OF DRUG MATERIAL
Quality Risk Assessment of
B
INJECTION WEDGE
SPREADING OF GELATIN
F SPREADER BOX
PAT
LUBRICATION ROLLERS
COOLING DRUM
&Development of Feedback Control system
RIBBON CUTTING
Implementatn of
Control Strategy
C
DIE ROLLER
DIE ROLLER
G
COOLING DRUM
CAPSULE SEALING
H
COOILING OF RIBBON
SPREADER BOX
LUBRICATION ROLLERS
CONVEYER ROLL COOLING FAN
MELTING JACKET
DoE
& Development of Design Space
MELTING JACKET
CMAs & CPPs
COOLING FAN
NAPHTHA BATH WASHING
I
1 ° FLUID BED TUNNEL & 2° TRAY DRYING © Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF CRITICAL STEPs
DESIGNING PHASE
ANALYZING PHASE
CONTROLLING PHASE
Definition of
QTPP GELATIN MIXER /MELTER
MEDICINE HOPPER
CQAs
MOISTURE CONTENT of GEL MASS by At line Toluene Distillation Method
SPECIFIC GRAVITY Of fill material analyzed by online Sp. Gravity bottle
SPREADER BOX
PAT
INJECTION WEDGE
RIBBON THICKNESS LUBRICATION by On line Digital Stage ROLLERS Microscopy & Calipers
COOLING DRUM
&Development of Feedback Control system
Implementatn of
Control Strategy
SPREADER BOX
LUBRICATION ROLLERS DIE ROLLER
DIE ROLLER
CAPSULE FILL WEIGHT by On Line Weight Variation & Disintegration Testing
SEAL THICKNESS by On line Digital Stage Microscopy & Calipers
CONVEYER ROLL COOLING FAN
MELTING JACKET
MELTING JACKET
CMAs & CPPs
TEMPERATURE & RELATIVE HUMIDITY by At Line Thermohygrometer
HOMOGENEITY off FILL analyzed by At line UV/ HPLC system
VISCOSITY of GEL MASS by On line Brookfield Viscometer
Quality Risk Assessment of
DoE
API / EXCIPIENT PARTICLE SIZE DISTRIBUTION analyzed by At line Malvern Particle Size Analyzer OR On Line Sieve Shaker Analysis
MEDICINE PUMP
Determination of
& Development of Design Space
API / EXCIPIENT PURITY analyzed by At line UV/ HPLC/ GC, On line LOD/ HMB or W/KF
COOLING DRUM
ONLINE VISUAL INSPECTION for cleaning, polishing & sorting of unfilled/ half filled/ defective capsules
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
COOLING FAN RESIDUAL MOISTURE OF FILLED CAPSULES by At line Toluene Distillation Method
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF CRITICAL STEPs
DESIGNING PHASE
ANALYZING PHASE
CONTROLLING PHASE
Definition of
QTPP GELATIN MIXER /MELTER
API / EXCIPIENT PURITY analyzed by In line Bruker FT-NIR
MEDICINE HOPPER
API / EXCIPIENT PARTICLE SIZE DISTRIBUTION analyzed by In line Lasentec Focused Beam Reflectance Measurement (FBRM)
MEDICINE PUMP
Determination of
CQAs
MOISTURE CONTENT of GEL MASS by Inline Bruker/ MT FT_NIR System
HOMOGENEITY off FILL analyzed by In Line Bruketr FT_NIR
VISCOSITY of GEL MASS by In line Viscometer Quality Risk Assessment of
MELTING JACKET
INJECTION WEDGE
SPREADER BOX
PAT
RIBBON THICKNESS LUBRICATION by In line Digital HD ROLLERS Microscopy & Video Monitoring
COOLING DRUM
&Development of Feedback Control system
MELTING JACKET
DoE
& Development of Design Space
SPECIFIC GRAVITY Of FILL MATERIAL analyzed by inline hydrometer
SPECIFIC GRAVITY Of GEL MASS analyzed by inline hydrometer
CMAs & CPPs
TEMPERATURE & RELATIVE HUMIDITY by In Line Thermohygrometer
SPREADER BOX
LUBRICATION ROLLERS DIE ROLLER
DIE ROLLER
CAPSULE FILL WEIGHT by In line Check Weigher based on Gravimetric EMFR System
SEAL THICKNESS by In line Digital HD Microscopy & Video Monitoring
COOLING DRUM
CONTENT UNIFORMITY analyzed by In Line Bruker FT-NIR
CONVEYER ROLL Implementatn of
Control Strategy
DIAMETER SORTER for inline sorting of under/ overfill capsules
COOLING FAN
COOLING FAN COLOR SORTER for inline sorting of defective capsules with air bubbles
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
RESIDUAL MOISTURE OF FILLED CAPSULES by In line Bruker FT-NIR
© Created & Copyrighted by Shivang Chaudhary
IDENTIFICATION OF CRITICAL STEPs
DESIGNING PHASE
ANALYZING PHASE
CONTROLLING PHASE
Definition of
QTPP GELATIN MIXER /MELTER
MEDICINE HOPPER MEDICINE PUMP
Determination of
Auto-controlling of TEMPERATURE & RELATIVE HUMIDITY Air Handling Unit (AHU)
CQAs Auto Controlling of HOMOGENEITY off FILL By adjusting Homogenizer Mixing Speed & Mixing Time
Quality Risk Assessment of
SPREADER BOX
PAT
INJECTION WEDGE
Auto Controlling of LUBRICATION RIBBON THICKNESS ROLLERS by adjusting Gap between spreader box & rotating cooling drum COOLING DRUM
&Development of Feedback Control system
Implementatn of
Control Strategy
SPREADER BOX
LUBRICATION ROLLERS DIE ROLLER
DIE ROLLER
Auto-controlling of FILLED CAPSULE WEIGHT & by adjusting Die Roller Speed, Rotating Drum Speed
Auto controlling of SEAL THICKNESS by adjusting Gap between Die Rollers
CONVEYER ROLL COOLING FAN
MELTING JACKET
DoE
& Development of Design Space
MELTING JACKET
CMAs & CPPs
COOLING DRUM
Auto-controlling of RESIDUAL MOISTURE by adjusting Drying Temperature Drying Time
COOLING FAN
Application of Auto-controllers at real time Manufacturing scale For Continuously attaining Acceptable ranges of CMAs & CPPs with respect to desired CQAs © Created & Copyrighted by Shivang Chaudhary
Definition of
QTPP
QUALITY MEANS DOING IT RIGHT
WHEN NO ONE IS LOOKING Determination of
CQAs
Quality Risk Assessment of
CMAs & CPPs
DoE
& Development of Design Space
PAT
&Development of Feedback Control system
Created & 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
Implementatn of
Control Strategy
facebook.com/QbD.PAT.Pharmaceutical.Development https://in.linkedin.com/in/shivangchaudhary +91 -9904474045, +91-7567297579
© Copyrighted by Shivang Chaudhary
[email protected]
© Created & Copyrighted by Shivang Chaudhary
