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PAT (Process Analytical Technology) For “LIQUID PARENTERAL” Pharmaceuticals i.e. SVP & LVP Manufacturing Line ....

Article in Pharmaceutical Development and Technology · August 2013

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Shivang Chaudhary
National Institute of Pharmaceutical Education and Research
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Some of the authors of this publication are also working on these related projects:

Formulation R&D Engineer | Lean Quality by Design / Process Analytical Technology (F&D | Lean QbD / PAT) View project

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© Created & Copyrighted by Shivang Chaudhary

PROCESS ANALYTICAL TECHNOLOGY (PAT) FOR

LIQUID PARENTERAL PHARMACEUTICALS MANUFACTURING LINE
(shivaniper@gmail.com)

© Created & Copyrighted by Shivang Chaudhary

API / EXCIPIENT PURITY by STEAM FOR STERILIZATION WFI FOR CLEAN IN TEMPERATURE & RELATIVE
IN PLACE (SIP) PLACE (CIP) STEAM FOR STERILIZATION HUMIDITY by At Line
In line BRUKER FT-NIR WFI FOR CLEAN IN
STEAM FOR STERILIZATION WFI FOR CLEAN IN IN PLACE (SIP) Thermo-hygrometer
pH METER & PLACE (CIP)
IN PLACE (SIP) PLACE (CIP) DO METER NITROGEN
NITROGEN NITROGEN FLUSHING
API / EXCIPIENT PARTICLE FLUSHING FLUSHING DO METER
VACCUM & PRESSURE
SIZE DISTRIBUTION by DO METER PUM SYSTEM VACCUM & PRESSURE
In line Lasentec FBRM
COMPOUNDING PUM SYSTEM
VACCUM & PRESSURE VESSEL STORAGE
PUM SYSTEM VESSEL
STERILE
RATE OF STIRRING FOR COMPLETE
VACUUM WATER FOR INJECTION
WATER PHASE HOMOGENIZED STATE FOR SOLUTION
TRANSFER MANUFACTURING
HEATING & MIXING & by BRUKER FT-NIR
SYSTEM STORAGE
VESSEL VESSEL

WORKING
PLATFORM

RATE OF STERILIZATION by In RATE OF STERILIZATION by In

Line Chemical Indicator for Line Chemical Indicator for
Parametric Release Parametric Release

INTEGRATED FILTRATION FILTRATION

CONTROL PANEL
RATE OF STERILIZATION by At
Line Bacteriological Indicator
for Parametric Release
PYROGENS / ENDOTOXIN
ASSEMBLY & RATE OF CONTROLLED FLOCCULATION ASSEMBLY &
OR EFFECTIVE PRECIPITATION by In DETECTION by In Line
TRANSFER TRANSFER
Line Lasentec FBRM or PVM OR STERLIZATION PROCESS
PUMPS PUMPS
At Line SVR/SHR Tests FOR PARAMETER S RECORDING
SUSPENSION OR EMULSIONS OR At Line LAL Test
 LIQUID PARENTERAL (BFS) MANUFACTURING LINE WITH CONTROL STRATEGY &
PROCESS ANALYTICAL TECHNOLOGY
© Copyrighted by Shivang Chaudhary

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