Medical Device Testing
Biocompatibility and Toxicology
Biocompatibility testing is an important part of biological risk assessment. Our testing assesses the compatibility of medical devices with biological systems. Click the button below to know more.
EO Sterilization: Validation & Monitoring
To meet the required Sterility Assurance Level (SAL), EO sterilization process needs to be validated. At SaniChem, we offer a wide range of tests to help you validate your sterilization process in accordance with national and international standards.
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
Cleanroom & Facilities Monitoring
Facilities might be a source for production contamination. Therefore, periodically monitoring is needed to ensure the environment in a good condition. Click the button below to view the process flow of our cleanroom & facilities monitoring service
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