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In order to demonstrate that the packaging system is fit for purpose the manufacturer will subject the packaging to various validated test regimes
Manufacturers perform inspection and tests to ISO 11607-1 throughout the manufacturing process. These ensure sterility is maintained to the point of use.
Stability testing is designed to show that the packaging can maintain its integrity under different logistical and storage conditions over time.
Packaging design must take into account how the packaging may be used and is an important part of the risk management process.
Membership is open to Manufacturers of Sterilisation products or related services, with sales in Europe. Potential members also need to have implemented a quality management system certified by an accredited certification body.
For more details see Why become a member?
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