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- Sartoguard PES | 0.1 µm | Capsule (PD | Scale Up)
Sartoguard PES | Gamma Capsule | 0.1µm | Size 4 | 5pc.
Designed for scale-up in the PD area, these capsules provide consistent bioburden reduction and high throughput. The PES membrane ensures robust process control, making them suitable for transitioning from development to production.
Sterilization Method
Connector(s)
- Item No.:
- 5471358G4G-OO--B
- Pieces
- 5
Sartoguard PES | Gamma Capsule | 0.1µm | Size 4 | 5pc.
Designed for scale-up in the PD area, these capsules provide consistent bioburden reduction and high throughput. The PES membrane ensures robust process control, making them suitable for transitioning from development to production.
Overview
Specifications
Choose your Sartoguard PES
Sartoguard PES Prefilters
Sartoguard PES filters support bioburden reduction and membrane prefiltration for cell culture media and clarified harvests. High throughput and strong clarification help shorten cycles while protecting final sterilizing filters and downstream equipment.
Key Features
- Dual-Layer PES Membrane: Their two membrane layer design pairs clarification with bioburden retention, supporting stable flow and efficient prefiltration.
- High Throughput and Clarification: Sartoguard PES delivers excellent clarification of process fluids, helping reduce filter count and time per batch.
- Integrity Testable: On-site diffusion and bubble point testing support reliable qualification and routine release in development and production.
- Proven Bacteria Retention: Typical LRV 6 per cm² for Serratia marcescens (0.2 µm nominal) provides robust bioburden reduction for process fluids.
- Scalable Portfolio: Membrane areas from 4.5 cm² to 2.4 m² per element enable linear scale-up and economic sizing from PD to process scale.
Applications
- Cell Culture Media
- Downstream Intermediates
- Clarified cell culture harvest
- Buffers
- Aseptically filled Small Volume Parenteral
- Protection of final filters (before and after UF | DF and chromatography steps)
Benefits
- Efficient Bioburden Control: Retention performance and clarification help reduce microbial load and particulates, supporting consistent upstream and intermediate steps.
- Protection of Final Filters: Prefiltration reduces fouling of sterilizing-grade membranes, extending service life and helping to stabilize flow.
- Shorter Filtration Cycles: High throughput and economic sizing options support reduced processing time and streamlined operations.
- PFAS: Made without intentionally using PFAS compounds.
- Reliable Process Verification: Integrity testing by diffusion and bubble point supports reproducible qualification and confident release decisions.
- Seamless Scale-Up: Common materials and a wide area range simplify transitions from development to commercial scale and help standardize validation.
Applications
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Application
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mAB Production
- Protection of Final Filters
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mAB Production
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IndustryPharma / Biotech
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Modality
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Media Filtration
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Buffer & Auxiliaries Filtration
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Downstream Intermediates
- Form & Fill
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Media Filtration
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ScaleProduct Development | Scale Up Filters
Compliance Information
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Bacterial Endotoxins< 0.25 EU/mL as determined by the LAL test
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ExtractablesThe total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Connections (Physical)
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Connector Inlet1/4" Multiple Stepped Hose Barb
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Connector Outlet1/4" Multiple Stepped Hose Barb
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Connector(s)Inlet: ¼" Hose Barb | Outlet: ¼" Hose Barb
Dimensions
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Filter Sizesize 4 (0.021 m² / 0.22 ft²)
General Specifications
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Capsule/Cartridge FormatCapsules
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Maximum Diffusion1.1 mL/min at 1.5 bar | 22 psi
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Minimum Required Bubble Point2.8 bar | 40.5 psi
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Vent ValveStandard
Materials of Construction
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Housing MaterialPolypropylene (PP)
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Material o-ring | sealSilicone (SI)
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Membrane MaterialPolyethersulfone (PES)
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Support FleecePolyester (PET)
Operating Conditions
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Maximum Differential Pressure20 °C: 4 bar, 80 °C: 2 bar
Physicochemical Information
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Non-Fiber ReleasingThis filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
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Pore Size Final-filter0.1 µm
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Pore Size Pre-filter0.8 µm
Product Information
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BrandSartoguard PES
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Pack Size5
Sterility/Purity
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Delivery ConditionNon sterile - Gamma irradiatable
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Sterilization MethodGamma Irradiatable
Usage Protocols
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Sterilization ProceduresGamma Irradiation: with 50 kGy