does anyone know what are FDA expectations about the media fill to be performed before and/or after the facility shut down? I mean: a media fill performed before the facility shut down could be considered representative of the aseptic of the line also after the shut down? it could be sufficient the media fill performed before or I must perform the media fill also after the shut down?
The term “SHUT DOWN” defines as complete stoppage of all activities concerning to manufacturing including shutting down of Utilities --especially high impact utilities like HVAC, Water, Compressed Air and associated CIP/SIP and Steam generating systems.
A proper reason should be there to shut down a manufacturing facility.
Why on earth any one would even bother to invite a headache by performing a media fill?
This last media fill does not indicate or draw to any conclusions about the process that is any way going for a SHUT DOWN.
It is just wasting time.
To consider a media fill after the plant is reopened is essential. Before reaching this point of media fill it is essential to Qualify,Validate and verify all the utilities and facilities as depicted in STAGE-2 of the Process Validation guidance that was released in 2011 by FDA.
After sufficient proof that all the utilities are performing as per the regulatory expectation and with in prescribed ranges meeting all Quality attributes, it will be then better to think or plan a media fill.
In the eyes of a regulatory inspector this plant is as good as a Start-up plant.
As pe ISO 13408 guideline:
Schedule for media-fill shall occur at least six month for each product and aseptic filling line.
Aseptic line and product used less than six months shall be requalified with an acceptable media-fill test.
Product manufacture may resume after media-fill units are under incubation but release should not occur until acceptable media fill data are obtained
Media-fill Requalification of process or line prior to six months should be considered if, +
(i) Facility and equipment modification occur.
(ii) Changes in personnel.
(iii) Anomalies in environment monitoring results.
(iv) End product sterility testing.