sartorius,赛多利斯,54A8358N1-SS,Virosart Max 10" T-Style MaxiCap

sartorius,赛多利斯,54A8358N1-SS,Virosart Max 10" T-Style MaxiCap

描述

Virus filtration with Virosart® is an integral part of the orthogonal virus clearance technology platform of Sartorius Stedim Biotech. This orthogonal technology platform features virus filtration, virus inactivation and virus adsorption. The performance of the final virus filter mainly depends on the feed stream properties. Therefore, appropriate feed stream conditioning i.e. through efficient pre-filtration is a major aspect within the development of a virus filtration step.

Virosart® Max is a specifically optimized virus pre-filter significantly increasing downstream virus filter performance. This filter combines size exclusion mechanism with efficient adsorptive capacities to increase the robustness of the following virus filtration step. As a result, Virosart® Max ensures the highest protection of your final virus-retentive membrane, significantly increasing its robustness and capacity. The main application for Virosart® Max is the protection of the final virus retentive membrane. For that purpose this filter is used at the end of the purification process in-line with the final virus filtration step of the biopharmaceutical product.

The optimized pre-filter – final filter ratio should be determined during development of the virus filtration step. Virosart® Max provides highest protection to the virus retentive membrane with significant increase in robustness and capacity of the final virus filter. The most challenging molecules for the final virus retentive membrane are aggregates and | or small hydrophobic molecules. Virosart® Max binds aggregates very efficiently through hydrophobic interactions, independently of process conditions such as conductivity. The clean triple layer membrane material provides highest adsorptive capacities optimized for this process step. With the T-Style design the Virosart® Max MaxiCap® is ideal for easy installation of multiple filters in series or parallel.

Scale down work is realized using the Virosart® Max Minisart and | or Sartolab (5 cm2 | 21 cm2) to enable filtration work for capacity studies as well as optimizing the pre-filter final filter ratio of the final virus filtration step. Scale up studies are performed using Virosart® Max capsule and | or MidiCap® (220 cm2 | 2.100 cm2) to reliably scale up into larger scale manufacturing. Large scale manufacturing is operated with Virosart® Max T-Style MaxiCaps® or cartridges. Virosart® Max filters are tested for integrity using a water-based integrity test with the Sartocheck® technology of Sartorius Stedim Biotech.

Each individual Virosart® Max filter is autoclaved and integrity tested during manufacture assuring highest product reliability. Virosart® Max filters are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.

产品特性

类型	MaxiCaps®
初级产品类型	Filters
完整性测试	Yes
工业	Pharma/Biotech
高度	374 mm
过滤面积	0.7 m²
过滤器类型	Virus Prefilters
应用	Protection of Final Filters
Filter Format	Capsules
Capsule/Cartridge Format	MaxiCaps®

技术属性

连接器出口	1 1/2" Tri-Clamp 50mm
连接器进口	1 1/2" Tri-Clamp 50mm

sartorius,赛多利斯,54A8358N1-SS,Virosart Max 10" T-Style MaxiCap