The company providing the gamma sterilization for New Hole operates under FDA Regulations pertaining to sterilization for the medical community by complying with the guidance document for gamma sterilization known as ANSI/AAMI/ISO 11137-1:2006. This guideline also adheres to Europe’s sterilization standards and as written for medical device manufacturers; which will also cover New Hole products as well. Each New Hole Setup will have a manufacturer lot number, expiration date and contain an individual internal sterilization indicator that will change color when sterilized. This is just another step in providing assurance and protection to the consumer, you and your studio. Another huge advantage is the sterile reservoirs. As we can’t sterilize our ink caps, portion cups or medicine cups it becomes yet another possible way to cross-contaminate, the sterile reservoirs allow us to provide you with another way to help you eliminate cross contamination.
