What type of controls/room classifications/gowning, etc., would you expect for a media prep area of a dedicated biotech facility, especially if the media raw materials have a known but unpredictable level of bioburden?

The room classifications typically seen for the media areas have been Class 100,000. Most
manufacturing areas in a facility are Class 100,000, at least for the purposes of this guidance
document. Q7A addresses API drug substance. It is a different animal altogether when you go
towards the drug product end of things. I think the level of gowning that you would see may vary a
little bit. Some of the manufacturers may be using plant uniforms, but most of them are using
Tyvek gowns of some sort.