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Gravimetry

Photo Gravimétrie

 The cleanliness analysis is given by the difference of weight measured on a dry membrane before and after filtration of the solution used for the extraction of the contamination of the controlled part.


UV and low-angled light

 

Photo_Lumière UV Rasante ENG

The sample to be controlled is illuminated by a low-angled light and UV in a black box permitting the visual detection and localization of particles or traces > 50 µm
Liquid Particle Counting (LPC)

Principe_LPC

The particle contamination of the part to be controlled is extracted with DI water (18 Mohms, filtered at 0,2 µm + ultrasonics, shaking table, …).

A sample of the extracted solution is analyzed with a LPC counting system. The difference between the number of particles from the blank solution and the extracted solution indicates the level of cleanliness of the product.

Granulometry

photo Granulométrie

Gravimetric membranes are scanned and then analyzed by a specific imaging software. This tool is a fast and reliable solution to have the complete cartography of particles and fibers (their number and size) and their properties (size limit > 10 µm).

 

Titration

Dosage

Titration of pharmaceutical solutions

Ionic contamination

CI

Ionic contamination by extraction with a solution of DI water and analyzed by ion chromatography (IC).

Analysis by SEM-EDX

 

MEB-EDX

Determination of the chemical composition of the residual particles deposited on a membrane by Scanning Electron Microscopy (SEM), coupled with Energy Dispersive X-ray (EDX) analysis.

Endotoxin analysis

Endotoxines

LAL test on clean bottles, according to the European Pharmacopeia.

Microbiological controls

 

Microbio

Microbiological analysis are performed on bags, bottles and caps.

Bioburden test and BCI test, according to the ISO 11737-1 norm.

Test realized on 1,2 or 3 culture media of micro-organisms for detection of aerobic flora, anaerobic flora or yeast and fungi

Packaging sealing validation

 

Photo_Validation scellage d’un emballage

Sealing bag control according to the ISO 11607-2 norm.

The sealing is controlled  in our laboratory via  mechanical resistance, cleanability and permeability tests.

 

Tracking of a specific contaminant

 

Prove that a specific contaminant is no more present on the product after the cleaning process. This method is similar to the tracking of surfactant trace after detection of the type of tracer of he contaminant: ionic, metallic, organic,…

 

Corrosion assay

 

Etude corosion

 

Non Volatile organic residue control

 

Dosage

Weight of contamination extracted with an evaporated solvent

Photo Contrôle résidus

Evaluation of residual organic contamination by surface tension measurement

 

Environmental Control

 

Environnement_control

Clean-room control for particles and microbiological contaminants.

Humidity control

Humidite

Humidity absence control (as well as volatile, residual compounds) by desiccation and weighing.

.Monitoring of humidity released after cleaning via embedded sensor.

Metallic contamination

 

ICPMS

Metallic contamination by extraction via an acidified solution and analysis by ICPMS.

 

Organic contamination

 

FTIR

Organic contamination by gas chromatography coupled with mass spectrometry, liquid chromatography or by FTIR, depending on the part to analyze

Sterility test of solutions

Sterility test of « Ready To Use » solutions, according to chapter 2.6.1 of the European Pharmacopeia.

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