Virosart CPV Minisart cap 5cm²/box of 5 545VI----------B

Description

Virus filtration with Virosart^® CPV is an integral part of the orthogonal virus clearance technology platform at Sartorius Stedim Biotech. This orthogonal technology platform features virus filtration, virus inactivation and virus adsorption. Virosart^® CPV shows efficient removal of both small non-enveloped viruses (20 nm) and large enveloped viruses (>50 nm) from biopharmaceutical feed stream by size exclusion. The double layer 20 nm PESU membrane of Virosart^® CPV features excellent flow rates and superior capacity. The filter offers highest viral safety over the entire flow decay profile up to 90%. Virosart ^® CPV filters are being tested for integrity using a water based integrity test. All filters have been validated for 4 log10 removal of small non-enveloped viruses using bacteriophage PP7 as a model virus. Each individual Virosart^® CPV filter is autoclaved and integrity tested during manufacturing assuring highest product reliability.

Virosart^® CPV provides highest viral safety to the biopharmaceutical product. This filter retains more than 4 log10 of small nonenveloped viruses (PPV or MVM) and more than 6 log10 of large enveloped viruses (e.g. MuLV). Based on the unique double layer 20 nm PESU membrane, Virosart^® CPV provides excellent flow rates and superior capacity. This filter offers highest viral safety over the entire flow decay profile of up to 90%.

Scalability:

Scale down work is being realised using the Virosart^® CPV Minisart (5 cm² capsule) to enable filtration work for flow and capacity studies as well as for GLP virus spiking studies. Scale up studies are being performed using this capsules size 9 with filter area of 2.000 cm² to reliably scale up into larger scale manufacturing. Typical batch sizes of products being subject to nanofiltration with this Virosart^® CPV capsule size 9 are 5 to 50 liter.

Product properties

Application Note

• Appl_Virosart-01_SPK4109-e.pdf  (199 KB)

Datasheet

• Data_Virosart-CPV_SPK2065-e.pdf  (294 KB)
• Data_Virosart-CPV_Capsules_SPK2070-e.pdf  (146 KB)

Manual

• Manual_VirosartCPV_Cartirdges+MaxiCaps_SPK6520-e.pdf  (52 KB)
• Manual_VirosartCPV_MidiCaps_SPK6522-a.pdf  (83 KB)