The Sterilization Exposure Cycles Service exposes samples to a 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 11135-1:2014 recommends that the product and packaging meet safety, quality, and performance standards 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, and dry heat sterilizers that mimic customers’ sterilization processes. Samples can be exposed faster and less expensively than with the corresponding contract sterilization cycles.
Study Outline
The Sterilization Exposure Cycles ensure feasibility and functionality following a product’s exposure to the worst-case sterilization cycle. This is essential, since sterilization processes can be damaging to the finished product and packaging due to exposure to high temperatures, pressure and vacuum changes, humidity, and the sterilant.
Important note: There is an inherent risk of product damage during sterilization due to excess moisture and/or possible temperature spikes during steam addition. It is the responsibility of the sponsor to assess this risk and determine the suitability of their product. Nelson Labs does not assume responsibility for this risk.
Sample size required: The largest EO chamber at Nelson labs has usable space of 18 x 18 x 36 inches. If samples do not fit into the sterilizers in a single load, they may be divided into multiple loads to accommodate the samples.
It is the responsibility of the sponsor to verify sample dimensions in order to prevent any delays with their exposure.
In addition to Sterilization Exposure Cycles, we provide a vast catalog of Sterilization Validations approaches and cycle optimization ensures customers have a reliable, defensible validation strategy.
Applicable Standards
- ISO 11135
