Keystone has developed a Ethelene Oxide based sterilization cycle that is adaptable to a variety of medical devices. We have cleared the path for product adoption by using a robust protocol and challenge device. Once a product is adopted into the validation, Keystone can manage bioburden monitoring, scheduling and logistics for routine cycles, and review of records related to routine production. We can also coordinate product and package testing with our partners at third party laboratories across the United States.
Keystone offers sterilization management as a service to our customers that need sterilization as part of their contract manufacturing program. For customers, this means that they may be able to leverage Keystone’s existing validated cycle to bring their products to market in a fraction of the time it would take to develop a cycle from the ground up.
We can offer an integrated and managed solution for our customers which can save them time by leveraging our supply chain and competitive rates. For some customers, this can be a big benefit since we are able to scale sterilization capacity to support production sizes of less than a full chamber. This can help control costs and give more flexibility to customers for product release schedules.
One of Keystone’s unique offerings is that we have manufacturing capacity and sterilization partners that will allow us to economically process a range of product volumes and types from several small boxes to a dozen pallets a month.