Author Topic: Total airborne particle testing in ISO 5 non-aseptic areas  (Read 2583 times)


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Total airborne particle testing in ISO 5 non-aseptic areas
« on: October 12, 2012, 11:49:51 PM »
I have heard recently that FDA inspectors are requiring real-time, continuous, monitoring for total air borne particulates in ISO 5 areas which are not part of aseptic filling operations.  These ISO 5 LFBSCs were used for cell banking, for upstream cell culture handling and for final bulk drug substance filling.  All of this is at the production facility, completely separate from the aseptic filling which is done in a different facility.

Are you aware for the rationale for this requirement from FDA?


Glenn Irish

Durga Prasad

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Re: Total airborne particle testing in ISO 5 non-aseptic areas
« Reply #1 on: November 28, 2012, 06:52:41 AM »
This is an old concept and thought. Now this is completely changed after the advent and usage of Single use systems. In this case you can have both facilities in the same building.
There is a concept by name Ball room concept was proposed in the down stream operations which uses Single use technologies and the whole area is is Class D area.
The bulk product can be filled in a classified area and transferred to the filling section.
This concept is being slowly adopted by companies.

The only point you need to clarify during PAI from FDA is that there is no cross flow and cross contamination of Materials from Processes, Air and complete physical separation of individual processes.


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