Pharma
MEDICAL DEVICES
Chelab Pharma Division carries out laboratory tests for the verification of essential requirements of the MMD Directive, by application of relevant harmonysed standards.
Analytical services:
- Chemical-physical characterization of medical device materials:
- IR identification
- Mass spectrometry
- HPLC and GC purity and related substances
- ICP and AA metal traces
- Scanning electron microscopy and X-ray diffraction
- Differential scanning calorimetry (DSC)
- Biological evaluation of medical devices
- Genotoxicity
- Cytotoxicity
- Mutagenesis studies
- In vitro irritation test
- Analysis for the validation of sterilization processes
- Sterility test
- Test for the research of bacterial endotoxins
- Verification of chemical sterilization residues
- Environmental monitoring
- Studies on substances that can be released by packaging
- Leaching and compatibility tests of materials, mixtures and tissues
- Shelf life tests
- Test for the evaluation of preservative activity (challenge test)
- Consulting for the elaboration of technical documentation required by MDD
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