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Inspection Parenterals

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Inspection Parenterals
Bethesda 2005 PDA Visual Inspection
The Top Ten compounds of particulate contamination in parenterals
Markus Lankers Rap.ID Particle Systems GmbH

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Bethesda October 20, 2005

Liquid Particle Explorer: Number Size, Composition in Minutes

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Liquid Particle Explorer®
Number

Particles >2µm
•Fully Automated •Easy Calibration

Size Shape Chemical Composition (ID)

Liquid Particle Explorer: Number Size, Composition in Minutes

Visual Inspection - Production given: product free of visible (foreign) particles (>50 µm) results: 1. 100 % visual inspection 2. separation of rejects 3. removal of rejects 4. reject rate (PM): 0.2-3%

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Liquid Particle Explorer: Number Size, Composition in Minutes

Know Your Particles particle !

Source ! source ?

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Liquid Particle Explorer: Number Size, Composition in Minutes

Particle Characterization in the Lab method light microscopy EDX analysis IR – microscopy RAMAN microscopy meaning colour + form e.g.: black fibres elements e.g.: 96% Fe, 4%Cr,.. compounds e.g.: Teflon, PE, compounds e.g.: Teflon, PE, TiO2

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time/particle 1-5 min 60-180 min 60-180 min 60-180 min

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Chemical Analysis

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Polyethylene
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Measurement
•membrane filtration 1 •measurement 3

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2 1

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Filter

Scan Fields

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•Membrane (0.8 µm, 3 µm) RAMAN inactive

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Image Analysis
5µ m

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Liquid Particle Explorer: Number Size, Composition in Minutes

8µ m

Automated Spectroscopy

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Liquid Particle Explorer: Number Size, Composition in Minutes

RAMAN Spectroscopy laser spectrometer

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nodge

ccd- detector

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Documentation

data tracking

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