For purposes of this guidance, sterile product refers to one or more of the elements exposed to aseptic conditions and ultimately making up the sterile finished drug product. These elements include the containers, closures, and components of the finished drug product.
Source: GMP Draft Annex 1
How Big is a Micron?
How often do we actually think about how small a micron actually is?Read more
HEPA and ULPA Air Filtration
Connect 2 Cleanrooms typically use individual fan filter units to control airborne particles, and lo...Read more
A true cleanroom panel, this system is perfect for projects which need to adhere to GMP guidelines.Read more