The low-concentration CHG used in Irrisept acts as a preservative and maintains product sterility throughout the product life cycle. Irrisept uses CHG in its pure form diluted in an FDA-registered GMP manufacturing site where the amount of CHG in the solution is tightly controlled and scientifically validated. The Irrisept product is aseptically filled and the sterility of the product is controlled during manufacturing. Irrisept is packaged in Tyvek-sealed containers and sterilized as a medical device system.