3. Qualifying the performance of sterilizing filters

by Corinne DANAN and Alain RACHON

Sterilizing filtration belongs to the field of microfiltration. It is defined as a process which, when properly validated, is capable of physically retaining all micro-organisms from a fluid (gas or liquid), producing a sterile effluent downstream of the filter . Viruses are not considered in this document. This sterilization technique avoids heat treatment and...

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Qualifying the performance of sterilizing filters

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page Control and validation of medical device sterilization processes using microbiological methods

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References

Paragraph 1

(1) - Stérilisation des dispositifs médicaux – Méthodes microbiologiques – Essais de stérilité pratiqués en cours de validation d'un procédé de stérilisation. - Norme NF EN ISO 11737-2, juin 2000.
(2) - Stérilisation des produits de santé – Exigences...

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