Sartorius, Octoplus-FF, Octoplus® Final Filling Assembly

Octoplus FF® technology is a SU system replacing the traditional stainless steel surge tank containing the drug product in the filling area. With one single bag design, Octoplus FF® covers most of the fill & finish processes, from small scale up to large scale and high-speed applications.

Octoplus FF® accommodates to Production Scale and Drug Product Specificities
The large design space of the Octoplus FF® makes it adaptable to multiple filling line designs:
From clinical to commercial scale with 2 to 10 lines assembled to the bag
From small to large volume final containers with different tubing and needle diameters from 0,8 mm to > 7 mm
Component database (tubing, needle) to adapt to various filling lines
The bag chamber has vent filters to allow the system to breathe during filling:
It is compatible with high-speed repartition with no risk to stress the bag
With this option, the Octoplus FF® can be used for filling oxygen-sensitive products by using these vent filters for nitrogen neutralization.
Octoplus FF® Simplifies and Secures Drug Product final filling
The Octoplus FF® together with our Biosafe® system provides a robust validated platform for final fill:
Produces consistent and repeatable filling accuracy from 0.5 mL to 500 mL
Maximizes product recovery and ease draining thanks to its optimized bag design
Accommodates to production scale and drug product specificities, facilitating scale up from clinical to commercial
Fast tracks validation work with highly characterized materials
Provides a complete aseptic processing platform in combination with Biosafe®
Octoplus FF® simplifies the setup, reduces turnaround time and provides a fast and accurate filling process for both clinical and commercial productions

Specifications
Applications:
Application Area: Final filling
Process Step: Drug Product Final Filling

Compliance Information:
Lot Release Testing: Yes

Connections (Physical):
Connector(s): Opta® SFT Connector; KPC; Tri-clamp; MPC
Line LeakTest: 100% Leak tested in line
Port Diameter: 110 mm if RAFT configuration

Dimensions:
Dimensions: 495 mm × 530 mm (wallet shape)
Tube Length: Upon request

Features:
Integrity Tested: Upon Request
Number of Lines: 2 - 10

General Specifications:
Maximum Recovery Rate: 99.5 %
Tubing: Silicone (Tuflux® SIL); Silicone (Accusil™); Silicone (Liveo® Pharma Advanced Pump Tubing); TPE (Tuflux® TPE); Other platinum-cured silicone available upon request

Materials of Construction:
Film Material: Film S40: Polyethylene (PE)
Tubing Material: Synthetic Thermoplastic Elastomer; Platinum-Cured Silicone

Product Information:
Brand: Octoplus FF®
Filling Accuracy: 40% better than with Manifold type design

Sterility/Purity:
Delivery Condition: Sterile

Volume:
Volume Range: 8 L