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Modest Size, Bold Functionality Floor space in biopharmaceutical downstream processing areas remains at a premium. For many facilities that cannot accommodate large skid systems, we have designed the world’s most compact automated virus filtration system. With a footprint of a modest 864 mm x 686 mm (34 in. x 27 in.), the VFC can be installed in almost any downstream processing area.
By incorporating the capability to perform integrity testing, the VFC offers all the functionality needed to use Planova filters in your process. All of these steps can be performed on the VFC: pre-use visual leakage test (VLT), pre-use flush, product filtration, product recovery flush and post-use integrity tests.
Automation for TodayAs inclusion of a virus filtration step increases the safety of biopharmaceuticals and plasma derivatives, reducing the risk of operator error is a critical consideration. The intent of any automated system is to make routine tasks simpler and more efficient, while reducing the risk of errors. Our automation engineers value these basic tenets and have developed a robust automation platform with touchscreen control of typical virus filtration phases. The system is intuitive and requires minimal training.
The Controller also features our Visual Status Indicator (VSI), an LED sequence display that informs the operator about the current state of the system and is clearly understood from a distance.
As a leading equipment manufacturer devoted to solving therapeutic product safety and efficiency challenges within the biopharmaceutical and plasma derivatives industries, Asahi Kasei Bioprocess understands that manufacturing groups require automated tools to ensure problem-free virus filtration. As such, we have developed an updated Planova™ Virus Filtration Controller (VFC) to automate the virus filtration unit operation. With a wider operating range, 21CFR Part 11 compliant automation platform, and integrated visual leakage testing, the VFC enables reliable virus filtration in a small format that is ideal for both clinical and commercial cGMP manufacturing areas.
Planova™ Virus Filtration Controller
DATA FILE | UME97P01-2.0
Intuitive automation and a small form factor for reliable virus filtration using Planova 15N, 20N, 35N or BioEX filters.
VFC Process Control Screen
2 |
VFC Operating Ranges The VFC can accommodate the following filters.
Filter Type Number Effective Surface Area
Planova 15N1 or 2 in parallel 1.0 m2
1 or 2 in parallel 4.0 m2
Planova 20N1 or 2 in parallel 1.0 m2
1 or 2 in parallel 4.0 m2
Planova BioEX1 or 2 in parallel 1.0 m2
1 4.0 m2
Utility for TomorrowClinical and commercial manufacturing sites must be adaptable to wide number of molecules, each with their own nuanced processes. We understand these challenges, and we have engineered the VFC to accommodate manufacturing scale Planova and Planova BioEX virus removal filters and the flexible use of pressurized feed vessels and single-use bags. For batch sizes as small as 20 L and as large as 1000 L, the Controller helps you run your virus removal step in a safe and efficient manner, today and in the future.
Set-up Guide The VFC accommodates the following four configurations of supplying your product, buffer and WFI to the filter.
Configuration
Feed No. 1 No. 2 No. 3 No. 4
Product Bag Pressurized Tank Pressurized Tank Pressurized Tank
Buffer Bag Bag Pressurized Tank Pressurized Tank
WFI Bag Bag Bag Pressurized Tank
Note: Pressurized tanks supplied separately or supplied by end user. Feed from bags using on-board diaphragm pump is flux decay-limited due to 100x pump turndown.
Engineered to accommodate manufacturing scale Planova and Planova BioEX filters.
P1 P2 P3FLOW
Optional pressure
Optional prefilter
Inlet pressure
Permeate pressure
Permeate
Filtered drain
Unfiltered drain
Backpressure control
Product feed (by pressurized tank)
Product feed (by pump)
Buffer
Clean air
WFI
Drain Figure 1. Flow schematic.
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VFC SpecificationsOperating system flow rate range 0.08 to 8.00 L/min
Operating pump flow rate range 0.10 to 8.00 L/min
Maximum operating pressure 4.41 barg at 40 °C
Inlets Five (Clean Air, WFI, Buffer, Pump Feed, Pressure Feed)
Bar code scanner For filter identification prior to use
Process connections Tri-Clamp® (Tri-Clamp is a registered trademark of Alfa Laval Corporate AB)
Feed side material of construction (MOC) 316L SS / 0.5 µm Ra
Permeate side MOC 316L SS / 0.5 µm Ra
Elastomer MOC PTFE and EPDM (USP Class VI)
Product feed By separate pressurized tank or onboard diaphragm pump†
Line size 3/4 in. inlets; 1/2 in. feed side and permeate side
Pre-filter Optional Code 7 housing or capsule filter
Hold-up volume* Approximately 400 mL
Temperature range 4 – 40 °C
Flow method Pressurized tank (tank supplied separately) or diaphragm pump
Control method Filter differential pressure control
Utility requirements120 VAC 1-phase 60 Hz plus 460 VAC 3-phase 60 Hz or230 VAC 1-phase 50 Hz plus 380/400/415 VAC 3-phase 50 Hz5.5 barg instrument air, optionally 2.25 barg clean air
Electrical protection NEMA 4X, IP55
Instrument rating IP65
Dimensions 864 mm (34 in.) W x 686 mm (27 in.) D x 1930 mm (76 in.) H
Operator interface Local touchscreen display
Automation Siemens
Software compliance 21CFR Part 11 compliant
Certificates Certificates of Compliance, Material Certificates 2.1 per EN 10204
Documentation One electronic copy provided
Qualification package Asahi IQ/OQ package available and CE Declaration of Conformity available
Note: Flux decay is limited when using the onboard diaphragm pump for product feed.
*Excludes pre-filter
Accessorize your ControllerSelect the appropriate Planova filter mounting kit and hose kit for your Controller. Optional pre-filter housing, feed tanks and qualification packages are also available.
IQ/OQ packages for the Controller are available to support cGMP manufacturing, as are pressurized tanks in various sizes.
Contact Information
For more information, please visit:www.ak-bio.com
Planova is a registered trademark of Asahi Kasei Medical Co., Ltd.
© 2018 Asahi Kasei Bioprocess America, Inc. All rights reserved.
India and Southeast Asia
Mumbai, IndiaTel: +91-22-6710-3962Fax: +91-22-6710-3979
Email: [email protected]
East Asia and Oceania
Glenview, IL, USATel: +1-847-556-9700 Fax: +1-847-556-9701
Email: [email protected]
Europe
Cologne, GermanyTel: +49-221-995007-59Fax: +49-221-9950077-59
Email: [email protected]
North and South America
Glenview, IL, USATel: +1-847-556-9700 Fax: +1-847-556-9701
Email: [email protected]
Ordering Information
Catalog No. Description
VFC008 Planova Virus Filtration Controller, SS
VFC009 Spare parts kit (wear parts) for VFC
20055-0010 Filter holder for 1.0 m2 Planova filter
VFC310 Hose kit for 1.0 m2 Planova filter
VFC340 Hose kit for 4.0 m2 Planova filter
VFC510 Optional pre-filter, 10 in. Code 7 housing
VFC402 Optional conductivity monitoring
SRV302 GMP system documentation package
VFC705 50 L pressurized tank with accessories
VFC710 100 L pressurized tank with accessories
VFC720 200 L pressurized tank with accessories
VFC112 VFC IQ/OQ package
Note: Technical support for the Planova Virus Filtration Controller is available throughout the United States, Europe and Asia.
