Product Tank, tubing, and SLTP Beta with internal connections are all Steam In Place (SIP) sterilized together. SIP docking plate with SLTP Beta is secured to tank or other safe process location.
Liquid product is filter-sterilized into the tank, where it is now ready to transfer to the filling area.
The fill head, tubing, and other product contact parts are sterilized in an autoclavable Beta container. A hydrophobic filter is used on the container’s vent to disallow entry of spores after sterilization. When autoclaved, terminal sterilization is achieved and is maintained within the container during transfer and connection to the filling line isolator or RABS.
SLTP Beta is connected to CRTP Alpha on containment wall, e.g., isolator or RABS.
The double doors are opened inside the aseptic containment, exposing the sterile product tube for connection to the sterile fill head via pre-sterilized tubing and fittings from Step 3.
Tubing can be routed through pumps inside or outside of containment prior to the start of filling. Internal aseptic connections are made to the fill head using pre-sterilized Tri-clamp or barbed fittings.