Sterilization Exposure Cycles tests expose samples to a specific sterilization cycle to evaluate feasibility and functionality following the sterilization process. Various standards require that the form, fit and function of the medical device or product be evaluated after all production processes, up to and including sterilization.
ISO 11135-1: 2014 recommends that the product and packaging meet the safety, quality and performance standards "in the most demanding process parameters for the product / package". New products, changes in existing products, packaging evaluations, and even raw materials and components subjected to the given sterilization process should be tested to determine if any adverse effects have been observed.
EUROLABfeatures fully programmable ethylene oxide, steam and dry heat sterilizers that mimic customers' sterilization processes. Samples can be exposed faster and less expensively through corresponding contract sterilization cycles.
Sterilization Exposure Cycles provide feasibility and functionality after the product has been exposed to the worst sterilization cycle. This is important as sterilization processes can damage the final product and packaging due to exposure to high temperatures, pressure and vacuum changes, humidity and the sterilizer.
Important note: There is an inherent risk of product damage during sterilization due to excessive moisture and / or possible temperature increases during the addition of steam. It is the sponsor's responsibility to assess this risk and determine the suitability of their products.
Required sample size: EUROLAB The largest EO chamber in their laboratory has 18 x 18 x 36 inches of usable space. If samples do not fit sterilizers in a single load, they can be split into multiple loads to accommodate the samples.
It is the sponsor's responsibility to verify the sample sizes to avoid any delay associated with exposure.
EUROLAB, with its highly expert team and internationally accredited laboratories, Sterilization Exposure Tests It performs all test, analysis, measurement, evaluation and report generation services completely and reliably.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
