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Medical Device Testing
Gamma Sterilization: Validation & Monitoring
To achieve a sterile label claim product, an appropriate sterilization dose must be established. The sterilization dose shall be validated accordingly. At SaniChem, we offer a wide range of tests to help you validate your sterilization process in accordance with national and international standards.
Bacterial Endotoxin Test
Endotoxin test is used to predict the release of endotoxins from medical device. It is important to know whether an endotoxin test indicates an implant that has been contaminated or normal as the release of endotoxins from such implants can pose a risk to those receiving them
Understanding the microflora of your samples or environment will provide information on the sources of contamination and how to eliminate them. Here at Sanichem, we can identify bacteria, yeast and fungi using miniaturized biochemical test kits and microscopy. This is a more economical approach compared to genotypic methods such as PCR and sequencing.
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