Your facility has adopted single-use technology and requires problem-free virus filtration. Our Planova SU-VFC automates the virus filtration unit operation in a single-use format. With a flexible operating range, 21CFR Part 11 compliant automation platform, and gamma-irradiated tubing sets, the Planova SU-VFC enables reliable virus filtration for Planova 15N, 20N, 35N and BioEX filters in a small footprint that is ideal for single-use cGMP manufacturing areas.
The Planova SU-VFC includes several risk-mitigating features and design elements to ensure that your high-value biotherapeutic is safely, reproducibly and reliably filtered batch after batch – including our automation platform that allows for intuitive configuration of all virus filtration process steps.
With a footprint of a modest 660 mm x 1219 mm (26 in. x 48 in.), the Planova SU-VFC can be installed in almost any downstream processing area and is fully 21CFR Part 11 capable. Universal gamma-irradiated tubing sets can be used for any of our Planova filters. By incorporating the capability to perform integrity testing, the Planova SU-VFC permits simplified implementation of Planova filters in your process.
Sample Operational Steps:
System integrity test prior to operation
Deaeration
WFI flush
Optional pre-use visual leakage test
Optional flowmeter and pressure transmitter calibration
Product filtration
Filtration rinse
Filter wash
Optional post-use visual leakage test
Alarms and interlocks also included
Filter wash by EQ buffer