Every medical device manufacturer must conduct the Big Three biocompatibility tests, or provide justification why the tests were not performed. The Big Three tests include cytotoxicity, irritation, and sensitization. Cytotoxicity is an in vitro test, while irritation and sensitization tests are in vivo tests (conducted on animals). Now, we are on the verge of in vitro alternatives for these animal tests, making the big three cheaper, quicker, and having less impact on animals. This Tech Theater will cover:
- What are sensitization and irritation tests looking for?
- Why are we looking for in vitro alternatives?
- How do we conduct these tests?
- What is the status in vitro testing?