The Sterilization Exposure Cycles test exposes samples to the given sterilization cycle to assess feasibility and functionality following the sterilization process. Various standards require the form, fit, and function of a medical device or product to be assessed following all of the manufacturing processes up to and including sterilization.
ISO 11135-1:2007 recommends that the product and packaging meet safety, quality, and performance at the “most challenging process parameters for the product/package.” New products, modifications to current products, packaging assessments, and even raw materials and components that are exposed to the given sterilization process should be tested to determine if any adverse effects are observed.
Nelson Labs has fully programmable ethylene oxide, steam, vaporized hydrogen peroxide, and dry heat sterilizers that mimic customers’ sterilization processes. Samples tested can be exposed faster and less expensively than with the corresponding contract sterilization cycles.
- ISO 11135