A
Arnthor
Dear All,
My company is using EtO sterilization method for our medical device.
I have the following questions which need some assistance.
1. It is a must to have an aeration room?
2. Are there any regulatory requirements on aeration room?
3. If my company does not have an aeration room and found out during US FDA inspection, what will be the FDA action?
Please advise.
Best regards,
Arnthor
My company is using EtO sterilization method for our medical device.
I have the following questions which need some assistance.
1. It is a must to have an aeration room?
2. Are there any regulatory requirements on aeration room?
3. If my company does not have an aeration room and found out during US FDA inspection, what will be the FDA action?
Please advise.
Best regards,
Arnthor