High Parvovirus Clearance
Pegasus SV4 Virus Removal Filter Cartridges demonstrate highly-efficient clearance of both small ‘non-enveloped’ viruses as well as large viruses.Figure 1 provides an example of its high parvovirus clearance by showing the typical performance of a Pegasus SV4 filter in a 1 g.L
-1BSA solution, as per the PDA’s guidelines:
图 1
Retention of porcine parvovirus (PPV, n=4) and small spherical bacteriophage virus (PP7, n=9) by Pegasus Grade SV4 virus membrane in 1 g.L-1 BSA at 3.1 bar (45 psi)1
1PPV retention testing carried out at an independent virus validation test laboratory using 47 mm filter discs
Due to its resistance to flux decay and outstanding throughput properties, typical spikes will not have significant impact on the flux decay of Pegasus SV4 Virus Removal Filter Cartridges.
Constant, Stable Flow-Rate Performance with Outstanding Throughput Capacity
With the need to control the Cost Of Goods Sold being one of the main points of consideration in downstream processing, Pegasus SV4 Virus Removal Filter membrane has been designed to address this need by offering constant, stable flow-rate performance and outstanding throughput capacity, thereby improving process and cost control and enabling maximum virus filtration economy and efficiency.
Highly-Efficient and Economical
Pegasus SV4 Virus Filter membrane also demonstrates highlyefficient clearance of both small ‘non-enveloped’ viruses and large viruses, even showing constant, stable flow-rate performance when used with dilute or complex/concentrated biological fluids.It also offers stable pressure/flux capability in more complex or concentrated feeds, helping to improve virus filtration economy in highly-concentrated protein solutions.Figure 2 shows a typical flux profile for Pegasus SV4 Virus Removal Filter Cartridges when challenged with a monoclonal antibody solution.
图 2
Results of Filterability Tests at 2.1 bar (30 psi) or 3.1 bar (45 psi) with up to 25 g.L-1 (2.5%) MAb
*Performance predicted from tests performed on Pegasus SV4 Virus Removal Filter Discs (47 mm)
Reduces Processing Costs
Pegasus SV4 Virus Removal Filter Cartridges offer a very high filter area per cartridge (2.25 m
2) due to their unique, patented laidover pleat construction which enables significantly more filter membrane to be packed into each cartridge.This helps to maximize process productivity while minimizing process costs, by reducing the amount of filter cartridges required per installation, and helps minimize the hold-up volume of the virus filter system.
图 3
Laid-over pleat construction utilized by Pegasus SV4 Virus Removal Filter Cartridges
Superior Process Control and Safety
Pegasus SV4 Virus Removal Filter Cartridges offer the highest level of process control and safety in process-scale virus filtration.
Process Requirement:Aseptic Safety
Best practice – Pegasus SV4 Virus Removal Filter Cartridges can be cleaned-in-place (CIP) and steamed-in place (SIP) and are suitable for inclusion into available fully-automated systems.
Process Requirement:Easy, Reliable Integrity Testing
Best practice – Pegasus SV4 Virus Removal Filter Cartridges can be in-situ integrity tested both pre-use and post-use.
Table 1
Integrity Testing of Pegasus SV4 Virus Removal Filter Cartridges
|
|
|
Steam In Place (SIP) |
是 |
|
Autoclavable By User |
是 |
|
Integrity Test Pre-Use |
Yes (Non destructive, water-wet in situ) |
|
Integrity Test Post-Use |
Yes (Non destructive, water-wet in situ) |
|
|
图 4
Integrity Testing Pegasus SV4 Virus Removal Filter Cartridges with a palltronic® Flowstar Filter Integrity Test Instrument
Suitable for Inclusion in 颇尔’s Fully-Automated Virus Filtration Systems
颇尔 also offers fully-automated virus filtration systems that enable precise and consistent operation, together with improved process efficiency.The systems can be designed with steam-inplace (SIP), clean-in-place (CIP) and integrity-test-in-place (ITIP) capabilities.The Cluster-Filtration technology assures maximum filter integrity sensitivity.
颇尔’s range of fully automated virus filtration systems ensures the highest level of manufacturing safety and process performance.
图 5
Typical
颇尔 Fully-Automated Virus Filtration System
© CSL Ltd, 2010
Rigorous Quality Testing at Multiple Stages of Production
Throughout the process of manufacture of Pegasus SV4 Virus Removal Filter Cartridges,
颇尔’s rigorous quality control systems ensure consistent performance as per the product specification.
-
Quality Control at Multiple Production Stages
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100% fabrication integrity tested – correlated to PP7 bacteriophage removal
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Viral reduction tested with PP7 bacteriophage lot release test
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100% fabrication water flow tested
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Protein transmission tested
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Visual inspection control
Full Traceability, Fast and Efficient Data Entry
Each Pegasus SV4 Virus Removal Filter Cartridge is manufactured under a Quality Management System certified to ISO 9001:2008, and is easily identified by part number, lot number and a unique serial number, which are laser-marked on the filter cartridge as a two-dimensional (2D) barcode.These codes can be read by a barcode reader, enabling complete traceability of the manufacturing history.
图 6
Pegasus SV4 Virus Removal Filter Cartridge showing 2D barcode
图 7
Scanning a barcode on a Pegasus SV4 Virus Removal Filter Cartridge using a palltronic Barcode Reader and palltronic Flowstar IV Filter Integrity Test Instrument
High Quality Standards
The filter components have met the requirements for biological reactivity, in vivo, under USP <88> (for Class VI – 121 °C plastics) and in vitro, under USP <87> (Elution Test).
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Meets Cleanliness per USP <788> Particulate Matter in Injections
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Non-Fiber-Releasing per Title 21 of the U.S Code of Federal Regulations (CFR) parts 211.72 and 210.3 (b) (6)
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Non-Pyrogenic per USP <85> Bacterial Endotoxins Test
The filter cartridge does not contain materials of construction that are considered specified TSE or BSE-risk materials according to current legislation and guidelines (reference European CPMP EMA/410/01 and U.S. Code of Federal Regulations, Title 21 Part 189.5).
科学实验室服务
颇尔’s Scientific and Laboratory Services (SLS) group is available worldwide to provide you with the scientific and technical support you need to mitigate risk as part of your viral safety strategy.Our scientists have extensive experience in filtration and chromatographic methods, validating processes developed to prevent virus contamination, and developing standard operating procedures for the correct operation of virus removal technology in unit operations.Our experience also covers the necessary skills and expertise to appropriately document the entire approach, from test protocols that include scientific rationale related to methodology and sampling, to test execution including data analysis, followed by scientific report generation ready-prepared for regulatory submission.Learn more at
www.yl-guolv.com.
