Post on 02-Jun-2020
THE�REVOLUTIONARY�FRACTIONAL�LOBE�PROCESSORMoving�the�pharmaceutical�industry�from�batch�to�novel�continuous�processing�(B2C)
The�current�manufacturing�involves�single�or�multistage�batch�processes,�comprising�of�a�number�of�reactive�or�non-reactive�steps.��Every�stage�operation�has�to�be�supported�by�confirming�outcomes�either�through�testing�or�validation,�including�that�of�cleanliness.�Several�batch�processes�are�further�limited�by�either�a�lack�of�clearly�defined�end�point�or�lack�of�ability�to�produce�quality�attributes�consistently.�It�is�left�to�subjective�human�discretion�in�the�form�of�heuristics�or�rules�of�thumb�to�decide�the�end�point�rather�than�the�outcome�being�solely�dictated�by�design.�Subjective�discretion�
An�urgent�need�for�Continuous�Process
is�also�seen�in�managing�the�effect�of�most�inputs�including�several�environmental�or�supply�conditions�that�change�the�quality�and�characteristics�of�output.�This�leads�to�the�production�of�rejects,�rework�and�off-specification�products.�The�decisions�are�generally�investigative�relying�on�quality�certification�through�post-operative�analytical�testing�rather�than�assured�by�design.�The�sum�of�the�time�spent�at�various�stages�in�such�batch�processes�is�often�large�resulting�in�loss�of�efficiency.�Finally,�release�of�such�products�in�the�market�creates�enormous�risks�to�consumers,�regulators�and�producers.
STEERLife’s�Fractional�Lobe�Processor�(FLP)�offers�a�huge�leap�over�the�existing�batch�processing�equipment�and�the�current�continuous�manufacturing�equipment.�
The�rotating�members�of�the�FLP�may�be�considered�as�a�cascading�arrangement�of�infinitesimally�thin�layers�without�any�interruptions�or�discontinuities�with�the�unique�ability�to�wipe�themselves�clean.�FLP�provides�significant�improvement�in�building�both�temporal�and�spatial�control�in�engineering�the�process�through�removal�of�hot�spots�and�dead�zones�while�maintaining�seamless�process�
Introducing�the�revolutionary�Fractional�Lobe�Processor� �-Moving�from�ʻQuality�by�Testingʼ� to ʻQuality�by�Designʼ
continuity.�These�attributes�of�FLP�make�it�not�only�desirable�but�absolutely�essential�in�pharmaceutical�applications.�
The�energy�transfer�is�made�effective�using�thermal�or��mechanical�means�at�wide�ranging�magnitudes�with�minimal�shear�or�pressure�peaks.�This�provides�specific�advantages�in�handling�sensitive�input�materials�that�may�or�may��not�tolerate�adverse�influencing�factors.�The�multifold�increase�in�output�capacity��and�built-in�process�control�has�wide-ranging�pharmaceutical�applications.
Control�over�Work�in�Fractional�Lobe�Processor
The�FLP�has�the�ability�to�work�on�materials�in�solid�state�to�achieve�intimate�interaction�between�the�constituents�while�imparting�physico-chemical�changes�through�reaction,�de-volatilization,�shear,�compression,�elongation,�surface�renewal,�distribution,�dispersion�‒�either�alone�with�minimal�interfering�effects�from�other�actions�or�in�any�desirable�combination�of�actions.�
Work�imparted�by�the�Fractional�Lobe�provides�the�required�uniformity�in�a�three-dimensional�force�field�eliminating�hot�zones�that�could�result�in�material�degradation.�This�can�be�been�shown�by�mathematical�models�using�analytical�methods�or�computational�fluid�dynamic�models�based�on�principles�of�finite�elements�method.�Fractional�lobe�processor�completely�eliminates�meta-radial�shear,�thus�achieving�stable�and�improved�process�control.
Process�Analytics�with�Feed-Back�and�Feed-Forward�Control
Continuous�pharmaceutical�processing�when�combined�with�process�analytical�tools�allows�further�enhancement�in�control�of�the�product�quality�attributes.�This�is�achieved�by�finely�adjusting�for�variability�in�input�or�process�conditions.�These�controls�can�actually�be�programmed�into�the�controls�algorithm�to�establish�an� .intelligent�system
B2C-�Extrusion
Fixed�dose�combination�(FDC)�therapy�is�the�preferred�approach�to�treat�HIV�in�order�to�minimize�the�virus�developing�resistance.�Protease�inhibitors�given�either�alone�or�in�combination�have�an�important�role�in�the�treatment�of�HIV.�Currently�available�products�in�the�market�have�been�formulated�using�hot�melt�extrusion�process�to�make�solid�amorphous�state�with�hydrophilic�polymers�to�increase�aqueous�solubility.�Hot�melt�extrusion�process�involves�melting�of�drug�substance�at�elevated�processing�temperature�utilizing�a�combination�of�thermal�and�mechanical�energy�and�requires�a�tight�control�of�both�quantum�and�uniformity�of�work�being�carried�during�the�processing�in�order�to�meet�stringent�critical�quality�attributes�of�the�final�product.
STEERLife’s�experience�of�hot�melt�extrusion�using�FLP�for�shear-sensitive�material�clearly�demonstrates�significant�improvement�in�process�efficiency�as�measured�in�terms�of�both�improved�throughput�rate�and�quality�attributes�due�to�better�control�on�fundamental�processing�factors�such�as�residence�time,�shear�peak�and�uniformity�of�work.
B2C-�Fragmentation
Fractional�geometry�as�a�result�of�uniform�shear�fields�in�the�previous�sections�results�in�much�uniform�size�and�a�narrower�distribution�in�comparison�with�the�Erdmenger�geometry.�Plastic�energy�dissipation�is�an�important�physical�phenomenon�that�occurs�during�the�fragmentation�process.�As�a�result�of�lesser�effects�of�dissipation,�it�is�possible�to�fragment�the�material�with�lower�melting�point�or�glass�transition�temperature.
B2C�-�Granulation
Particle�size�distribution�of�pharmaceutical�powders�have�influence�on�every�step�of�manufacturing�processes�for�solid�oral�dosage�forms,�including�pre-mixing/mixing,�granulation,�drying,�milling,�blending,�coating,�encapsulation�or�compression.�Continuous�granulation�in�a�FLP�involves�particle�agglomeration�due�to�various�activating�factors�such�as�water,�moisture,�mechanical�shear�or�heat�either�alone�or�in�combination.�The�process�integrates�mixing,�granulation,�drying�and�sizing�steps�followed�typically�in�a�batch�process�into�a�single�continuous�process�to�produce�free�flowing�and�compressible�granules.�STEERLife’s�experience�with�this�process�clearly�demonstrates�improved�ability�to�produce�customized�granules�measured�both�in�terms�of�mean�and�distribution�of�particle�size�without�needing�separate�drying�and�milling�steps�as�process�downstream.
STEERLife’sFractional�Lobe�Processoravailable�as�highly�customised�from�Lab�to�Commercial�Scale�Operation�either�in�the�form�of:Ÿ Single�drive�-Single�Vessel(or)Ÿ Multiple�drive�-�Multiple�Vessel
Key�FeaturesŸ Pre-formulation,�Development,�Pilot�and�Commercial�Scale
Ÿ Conforms�to�GMPŸ Option�of�Clam�Shell�and�Segmented�Jiffy�Clamp�Barrel�Design
Ÿ Upstream:�Split/�Side�FeedingŸ Liquid/�Gas�injectionŸ Degassing
AdvantagesŸ ScalabilityŸ Process�FlexibilityŸ Easy�Cleaning�and�DismantlingŸ lnline�Process�Control�(PAT)Ÿ Better�mixing�capabilityŸ Shorter�residence�timeŸ Reliable�data�logging
ApplicationsŸ Exhibit�batchesŸ Clinical�batchesŸ Scale-up�studiesŸ Solid�Molecular�dispersionsŸ Bio-availability�EnhancementŸ Taste�MaskingŸ Sustained�Release
Specifications
CUSTOMISED�SOLUTIONS�FOR�COMMERCIAL�NEEDS
B2C�-E B2C�-F B2C-�G�(Novel�Hot�Melt�Extrusion),� �(Hot�Melt�Fragmentation)�and� �(Activated�Granulation)
ITʼS�TIMETO�CHANGE
STEERLife INDIA
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