K1 Competence Center - Initiated by the Federal Ministry of Transport, Innovation and Technology (BMVIT). and the Federal Ministry of Economy, Family and Youth (BMWFJ)Funded by the Austrian Research Promotion Agency (FFG), Land Steiermark and the

Styrian Business Promotion Agency (SFG).

Analytical and Process Equipment

Research Center Pharmaceutical Engineering GmbH (RCPE)

July 2013

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Overview Analytical Services I

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AttributeMeasurement

PrincipleMeasurement Device

Particle Size Laser Diffraction HELOS KR (Sympatec)

Particle Size Laser Diffraction Mastersizer 2000 (Malvern)

Particle Size & ShapeDynamic Picture

Analysis QICPIC (Sympatec)

Particle SizeDynamic Light

ScatteringNano ZS (Malvern)

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Overview Analytical Services II

AttributeMeasurement

PrincipleMeasurement Device

DensityGas Pressure

DifferentialAccuPyc 1340 Helium

Pyknometer (Micromeritics)

(Compacted) Bulk DensityVolume Change of Bulk

PowderPT-TD200 (Pharmatest)

Flow Properties / Fluidisation Segregation / Cohesion / Friction Angle

Normal Force, Shear Strength and Torque

FT4 Powder Rheometer System (FreemanTechnology)

Particle Size and Shape in Fluid Dispersion

Flow-Through Microscopy

MFI 5100 (Protein Simple)

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Overview Analytical Services III

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AttributeMeasurement

PrincipleMeasurement Device

Zeta PotentialLaser Doppler Micro-

ElectrophoresisNano ZS (Malvern)

Dissolution Rate / in vitro Drug Release Information

Dissolution Apparatus USP 1 (Basket) and

USP 2 (Paddle) / UV Spectrophotometer

DT820LH (Erweka) + UV/ViS Lambda 25

(Perkin Elmer)

FriabilityExposure of Tablets to Mechanical Shock and

Attrition

PTF10E(PharmaTest)

Density / Velocity of Sound

Oscillating U-tube Sensor

DSA 5000 M (Anton Paar)

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Overview Analytical Services IV

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AttributeMeasurement

PrincipleMeasurement Device

Specific Surface / Porosity

Gas Adsorption Krypton / Nitrogen,

BET (Brunauer–Emmett–Teller) theory

Tristar II 3020 (Micromeritics)

Specific Surface / Porosity

Gas Adsorption Nitrogen,

BET (Brunauer–Emmett–Teller) theory

ASAP 2000(Micromeritics)

Structure / Polymorphism / Inner Surface

Small and Wide Angle X-Ray Scattering

(SWAXS)

S3-Micro SWAXS (Hecus/Bruker)

Secondary Protein Structure / Extruder

Residence Time

Raman Scattering (Flexible Process

Probe)

RXN2 Hybrid

(Kaiser Optics)

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Overview Analytical Services V

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AttributeMeasurement

PrincipleMeasurement Device

Concentration /Enzyme Kinetics

UV/VIS Spectroscopy (Transmission,

Absorption)

Lambda 950 (Perkin Elmer)

Concentration / Reaction Kinetics

Fourier Transform IR/Near-IR

Spectroscopy (Transmission,

Absorption, Diffuse Reflection)

Spectrum 400 (PerkinElmer)

Concentration / Polymorphism / Surface

Mapping

Raman Scattering (Scan Stage, Flexible

Probe)

RamanStation 400 (PerkinElmer)

Concentration / Reaction Kinetics

In-lineNear-IR Spectroscopy

(Diffuse Reflection)

SentroPAT FO (Sentronic), Probes: DR LS 300 (Dynisco)

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Overview Analytical Services VI

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AttributeMeasurement

PrincipleMeasurement Device

ConcentrationSeperation via Ultra-High Pressure Liquid

Chromatography

Acquity UPLC + MS( Waters)

Concentration

Seperation via Liquid Chromatography / Photo Diode Array

Detector

Agilent 1260 HPLC + PDA(Agilent)

Identification of Substances

Triple- Quad Mass Spectroscopy

Alliance HPLC + MS(Waters)

ConcentrationSeperation via Gas Chromatography

Clarus500 (PerkinElmer)

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Overview Analytical Services VII

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AttributeMeasurement

PrincipleMeasurement Device

Contact Angle / Surface Tension

Sessile Drop and Captive Bubble Method

(Static & Dynamic)

Easydrop (Krüss)

Contact Angle / Surface Tension

Washburn Method for Powders / Sessile Drop

and Captive Bubble

KT100 (Krüss)

Nanoparticle InclusionSpray Drying (Piezoelectric

Pulverizer)

Nano Spray Dryer B-90 (Büchi)

Residual Moisture Content

Karl Fischer TitrationTitroLine 7500 KF

(SI Analytics )

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Overview Analytical Services VIII

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AttributeMeasurement

PrincipleMeasurement Device

Particle Shape / Imaging

MicroscopyDM4000 with

DFC290 Camera (Leica)

Weight (Precision 0.01 mg)

High Precision ScaleXP205DR /m

(Mettler Toledo)

Characterize Flow of Materials / Elasticity

EC Motor Drive with Normal Force and

Torque Sensor

Physica MCR 300

(Anton Paar)

Transformation Enthalpies / Specific Heat

Differential Scanning Calorimetry

DSC 204 F1 Phönix(Netzsch)

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Overview Analytical Services IX

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AttributeMeasurement

PrincipleMeasurement Device

Particle Separation due to differences in their size,

shape, or density Sifting Segregation

Jenike & Johanson Segregation Tester SS1

 

Testing of inhaled products, measuring the

aerodynamic particle size distribution

Inertial ImpactionCopley Scientific Cascade Impactor

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Overview Process Services I

Attribute Process Principle Process Device

Hot Melt ExtrusionPlastification, mixing,

degassing, shaping by twin screw

Micro 27 Extrusion System(Leistritz)

Hot Melt Extrusion

Plastification, mixing, degassing, shaping by

twin screw

ZSK18 Extrusion System(Coperion)

Downstream extrusion Rotating knifeDie Face Pelletizer

Prototype(Automatik)

Downstream extrusion Rotating knifeStrand Granulator P60E

(Automatik)

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Overview Process Services II

Attribute Process Principle Process Device

Mixing 3D rotation Shake MixerTurbula T2F

(WAB)

GranulationGranulation by applying

high shear forcesHigh Shear Mixer P25

(Diosna)

MillingCooling with liquid

nitrogen and millingCryo Mill (Retsch)

Capsule fillingFilling of capsules with

nozzles

Laboratory Capsule FillerLabby(MG2)

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Overview Process Services III

Attribute Process Principle Process Device

Tablet pressing Rotary pressLaboratory Tablet Press 102i

(Fette Compacting)

Tablet pressingSimulation of rotary

presses

Compaction SimulatorSTYLCAM 200R(MedelPharm)

Coating, drying, encapsulation

Fluid bedBatch Fluid

Bed System Ventilus(Innojet)

Coating, drying, encapsulation Fluid bed

Batch Fluid Bed System GPC G1

(Glatt Process Technology)

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Overview Process Services IV

Attribute Process Principle Process Device

Dosing of liquidsMicro annular gear

pumpHNP mzr 7205 G

Dosing of powder Loss in weight feederK-Tron

K-CL-SFS-KT20

Dosing of powderLoss in weight feeder

small scale

BrabenderDDW-DDSR20 Hyg.