Why the contact time after fogging must be 1 hour?
If you’re using micro organisation strip for validation there spore killing timing should be considered it should be 30 to 40 min
The contact time is settled according to the fog validation upon concept to be more than the kill time of the challenged Biological indicators used in validation which is already more resistance to fumigant
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Decontamination should be performed on cycle development.
! hour for contact sounds long and could be harmful for materials.
For cycle development you can use high resistant BIs (D value of 3 for example) which takes a long time to kill the BI.
It is important to have a balance point for having log 6 reduction (based on your requirements)
I my question is when I do fogging for filling area
I don’t understand your point
First your questions was not about fogging for filling area.
It is important to state your question with all related information
What I want to say is that fogging is not just on and of process, it is a process which needs to be validated and this can be done by cycle development. Filling line is operated in grade A area (laminar airflow, RABS, Isolator with a controlled environment.
fogging / decontamination can be performed on SOP or when a breach of the room/filling line has occurred.
Or if there is another external contamination happening.
Also if you work on batch base than you need to perform decontamination.
Specify which filling area u are referring to liquid orals or injectable s?
Decontamination is performed without the actual product. It does not matter if liquid orals or injectables. Important is the cycle development and the validation. Decontamination is not just putting hydrogen peroxide gas inside a chamber. There are many factors which has to be considered, the temperature, humidity, gassing time (Hi and low level), dwelling time, aeration time, the complexity of the filling line and chamber such as cRABS, isolator etc.
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