A
amooney
As I say - best to look at the hospital paper as a starting point for those not familiar with flexible chamber technology.
The Andersen flexible chamber systems (Anprolene, Series 3 and Series 4) do NOT inject EtO into product packages. The flexible chamber is NOT part of the product packaging.
Andersen, and others, DO make EtO sterilization systems that inject EtO into product packages. The Andersen system is called Sterijet. Even for Sterijet, validations would stil lbe done in accordance with ISO11135 as applicable, as it is the nearest applicable standard available. There is an NWIP out with ISO TC 198 which is specifically applicable to flexible chanber systems and this may well include Sterijet in due course.
The Andersen flexible chamber systems (Anprolene, Series 3 and Series 4) do NOT inject EtO into product packages. The flexible chamber is NOT part of the product packaging.
Andersen, and others, DO make EtO sterilization systems that inject EtO into product packages. The Andersen system is called Sterijet. Even for Sterijet, validations would stil lbe done in accordance with ISO11135 as applicable, as it is the nearest applicable standard available. There is an NWIP out with ISO TC 198 which is specifically applicable to flexible chanber systems and this may well include Sterijet in due course.