Gravimetry
UV and low-angled light
Liquid Particle Counting (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
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
Titration of pharmaceutical solutions
Ionic contamination
Ionic contamination by extraction with a solution of DI water and analyzed by ion chromatography (IC).
Analysis by SEM-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
LAL test on clean bottles, according to the European Pharmacopeia.
Microbiological controls
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
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
Non Volatile organic residue control
Weight of contamination extracted with an evaporated solvent
Evaluation of residual organic contamination by surface tension measurement
Environmental Control
Clean-room control for particles and microbiological contaminants.
Humidity control
Humidity absence control (as well as volatile, residual compounds) by desiccation and weighing.
.Monitoring of humidity released after cleaning via embedded sensor.
Metallic contamination
Metallic contamination by extraction via an acidified solution and analysis by ICPMS.
Organic contamination
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.
