Aseptic Fill Suite
The Aseptic Fill Suite has separate gowning and de-gowning rooms and is supplied with air from a completely dedicated air handling unit. This suite contains an ISO Class 5 barrier isolator that is used for sterile filtration and filling of product into final vials. The barrier isolator is sterilized between campaigns using a Steris VHP-1000 Vaporized Hydrogen Peroxide decontamination system.
- Separate gowning/de-gowning areas with unidirectional flow
- Separate AHU providing ISO Class 7 air, positive pressure
- ISO Class 5 barrier isolator with vaporized hydrogen peroxide (VHP) sterilization unit
- Equipment for dispensing bulk liquid (peristaltic dispensing pump) and capping vials