Feasibility Studies
Mitigate risk, save time, and save money
Establishing the cycle ahead of time
We receive a lot of interest from companies that have failed to achieve sterility at a commercial sterilization facility. While our process does not employ a deep vacuum, we can achieve what other companies have not simply because we have an infinite degree of process flexibility. Our feasibility studies often include seeding custom biological indicators within the device at the hardest to sterilize locations and then exposing them to a fractional cycle at worst-case parameters. By demonstrating the biological indicators are sterile at the hardest to sterilize location, we can predict (with a high degree of certainty) what the custom sterilization parameters will look like.
The paradigm of performing biocompatibility/age studies before validation is complete
It is common knowledge that bringing a device to market is more than just performing a validation—there is the requirement for biocompatibility, shelf-life, and shipping/transport studies, all of which require your devices to be exposed to the validated cycle prior to initiating these activities. Shelf life studies alone can consume a three to four-month time span simply as a function of the accelerated aging process. Add this to the time it takes to validate the process, and before you know it six valuable months have passed. A feasibility study will help us determine what your custom cycle will look like ahead of time so you can initiate any biocompatibility, shelf-life, shipping, and transportation studies before or concurrent with the sterilization performance qualification (validation)—thereby saving valuable time and money.
Price
Buy some peace of mind for ~$1,000.