Description
Pegasus™ SV4 membrane in Kleenpak™ Nova capsules, part of our Pall filtration portfolio, are single-use filter capsules with constant, stable flow-rates providing efficient, high viral clearance and significantly-reduced processing costs.
With the ever-present risk of virus contamination in biologic products, potential sources of virus contamination of biotechnology products include viruses associated with the cell lines (endogenous viruses), or viruses introduced into the bioreactor from culture medium or during the production processes (adventitious viruses). Viruses could also potentially be present in donations for plasma derivatives.
Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Filter Membrane are encapsulated, direct flow filters that combine robust, high viral clearance of parvovirus and larger viruses with high throughput capacity and stable flow rates, in both dilute and complex concentrated biological fluids. Consistent flow rates and high throughputs provide superior control of process performance and costs. The encapsulated format removes operating costs associated with traditional formats, such as cleaning and maintenance of filter housings, and cleaning validation. Capsules can be autoclaved and supplied as part of a single-use processing system such as a filter/tubing/biocontainer set.
Rigorous Quality Testing at Multiple Stages of Production
Throughout the process of manufacture of Kleenpak Nova Filter Capsules with Pegasus SV4 Virus Removal Membrane, rigorous quality control systems ensure consistent performance as per the product specification.
Quality Control at Multiple Production Stages
100 % fabrication integrity tested – correlated to PP7 bacteriophage removal
Viral reduction tested with PP7 bacteriophage lot release test
100 % fabrication water flow tested
Protein transmission tested
Visual inspection control
Full Traceability, Fast and Efficient Data Entry
Every capsule is manufactured under a Quality Management System certified to ISO 9001:2008, and is identified by a part number with unique lot and serial numbers, to allow complete traceability of the product manufacturing history, and to assist the user's own traceability systems.
High Quality Standards
The filter components have met requirements for biological reactivity, in vivo, under USP <88> (for Class VI – 121°C plastics) and in vitro, under USP <87> (Elution Test).
Meets Cleanliness per USP <788> Particulate Matter in Injections
Non-Fiber-Releasing per Title 21 of the U.S Code of Federal Regulations (CFR) parts 211.72 and 210.3 (b) (6)
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).
Scientific and Laboratory Services
Scientific and Laboratory Support (SLS) Global Technical Support group is available 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.
