Q
This is about a Novel non-traditional method of ETO sterilisation:
It is called Ethylene Oxide-in-a-Bag (EtO-in-a-Bag, Diffusion method, or Injection method)
This method differs from traditional EtO methods in that Ethylene Oxide-in-a-Bag specifies a volume of EtO instead of a concentration (e.g., 7.2 grains instead of 500-600 mg/L), uses an EtO cartridge or capsule, uses humidichips, or uses a long gas dwell time (e.g., greater than 8 hours).
This method consists of injecting or inserting ETO into a 7 or 35 liter bag which contains the packed products. The ETO diffuses into the product which is in the bag and finally diffuses out of the bag. Temperature is maintained at about 50°Celsius at ambient pressure.
FDA classifies this method as Novel non-traditional
Sterilisers that use that method are marketed by Andersen.
Is there any scientific literature on this ?
Has anybody experience in validating this method ?
Does anybody use this method for sterile medical devices (US or Europe or elsewhere) ?
Would you follow ISO 11135 or ISO 14937 for validating this process ?
There is thread Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion with a similar question but no answer.
Thanks for answering
(Please only answer if you are familiar with this method)
It is called Ethylene Oxide-in-a-Bag (EtO-in-a-Bag, Diffusion method, or Injection method)
This method differs from traditional EtO methods in that Ethylene Oxide-in-a-Bag specifies a volume of EtO instead of a concentration (e.g., 7.2 grains instead of 500-600 mg/L), uses an EtO cartridge or capsule, uses humidichips, or uses a long gas dwell time (e.g., greater than 8 hours).
This method consists of injecting or inserting ETO into a 7 or 35 liter bag which contains the packed products. The ETO diffuses into the product which is in the bag and finally diffuses out of the bag. Temperature is maintained at about 50°Celsius at ambient pressure.
FDA classifies this method as Novel non-traditional
Sterilisers that use that method are marketed by Andersen.
Is there any scientific literature on this ?
Has anybody experience in validating this method ?
Does anybody use this method for sterile medical devices (US or Europe or elsewhere) ?
Would you follow ISO 11135 or ISO 14937 for validating this process ?
There is thread Sterilization Validation ISO 14937 - Sterilizer that uses EO gas diffusion with a similar question but no answer.
Thanks for answering
(Please only answer if you are familiar with this method)