श्री चित्रा तिरुनाल आयुर्विज्ञान और प्रौद्योगिकी संस्थान, त्रिवेंद्रम
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Toxicology division is a premier laboratory in the country in the field of biomaterial toxicology, and has a full-fledged facility for the pre-clinical evaluation of various materials and medical devices as per International Standards like ISO, USP and ASTM. The main aim of the division is the toxicity evaluation of materials, intended for the fabrication of medical devices and to investigate the potential biological hazards by careful observation for unexpected adverse reactions or events in humans during clinical use of the medical device. The Pre-clinical toxicity/biocompatibility/safety studies of medical devices, pharmaceuticals, nanomaterials and tissue engineered products are accredited by COFRAC France as per ISO 17025.
The development of an " In vitro pyrogen test kit" for the evaluation of pyrogenicity using human whole blood" project is in the stage of successful completion. This new development will be an ELISA method for pyrogen test and will be suitable for evaluating wide spectrum of applications to measure the undetected non endotoxin pyrogens, such as pyrogens of any chemical or biological nature.
A new project entitled "Evaluation of molecular toxicity of newly developed materials intended for biomedical applications" is ongoing under the support of Indian Council of Medical Research (ICMR), New Delhi. The objective of the project is to evaluate the molecular level toxicity of the six newly developed materials and their chemical leachants on mtDNA, antioxidant enzymes, lipid peroxidation and cytogenetic effects. The expected out come of the project will be a cardinal change in approach to biocompatibility evaluations leading to a paradigm shift in bringing in newer regulations for development of safer medical devices, implants and tissue engineered organs for life time application.