Sartorius, 5498307H1G-SSHB, Sartopore® Platinum HB | T-Style Maxicaps® | 0.2µm | 10"

HB version: Membrane with high bubble point (≥ 4.1 bar)
Effective Filtration Area: 1.0 m² | 10.8 ft²
Pore Size: 0.45 µm prefilter | 0.2 µm final filter
Membrane Material: Modified polyethersulfone
Connectors: Inlet: Sanitary 1 ½“| Outlet: Sanitary 1 ½“
Sterilization: Hybrid: Gamma-irradiatable | Autoclavable
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Sartopore® Platinum HB (High Bubble Point) is the latest addition to the Sartopore® Platinum family. It offers the same superior performance as the standard version with an increased Bubble Point for challenging processes. This special type of filter is our recommended solution for fill & finish applications. The tighter membrane pores provide highest safety and reliability in sterile filtration.
High Bubble Point (≥ 4.1 bar) – increased process safety
Lowest protein adsorption – maximizing product yield
Excellent wettability – up to 95% less water needed
No wetting issues during integrity testing – preferred for single-use assemblies
High chemical compatibility (pH 1-14)
Temperature stable
Highest effective filter area (1 m2/10”) – less filter consumption
Low Extractables Level
Reliable Integrity Testing
Main Applications
Typical filtration applications include:
Biologicals
Pharma
Cell culture media (with and without serum)
Serum
Buffer
Membrane
Sartopore® Platinum uses a heterogeneous double membrane made of hydrophilized polyethersulfone, which is characterized by high performance data, excellent wettability, high chemical compatibility, high temperature stability and low protein absorption.
New surface coating
A new hydrophilization process has been developed to permanently modify the membrane surface. In this process, a thermally extremely stable and hydrophilic polymer is applied directly to the entire surface of the membrane. This technology creates the membrane properties that are responsible for the exceptionally good wettability and low protein binding of Sartopore® Platinum, even after extreme chemical and thermal stress. As a result, multiple evaporation cycles in dry and wet conditions and in both directions are possible without negative consequences in terms of wettability and integrity testing.
Compatibility
Sartopore®2 Maxicaps have been developed for sterilization using either gamma irradiation < in 50 kGy irradiation doses or autoclaving at 134°C | 2bar The polyethersulfone membrane used is suitable for the filtration of liquids in the pH range of pH 1-14. Therefore, Sartopore® Platinum Gamma filters are suitable for most filtration applications in the pharmaceutical and biotechnology sectors.
Excellent wettability
Sartopore® Platinum filters are very easy to wet with the inset of very small amounts of medium. Less than 1 litre of WFI is required to reliably wet a MidiCaps® height 9 (0.26 m²) and then test it for integrity. Due to the excellent wettability, WFI consumption can be significantly reduced, which significantly reduces filtration costs.
Reliable Integrity Testing
Insufficient wetting is one of the main reasons for failing filter integrity tests. In such a case, the affected filter must be rewetted and tested. In addition to the additional costs for the additional tests, there is the risk of losing an entire production batch in the event of repeated failures. The excellent wetting behavior of Sartopore® Platinum helps to eliminate this risk. The use of Sartopore® Platinum results in unprecedented reliability in integrity testing.
Cost savings:
The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.
Flexibility
Sartopore® Platinum filters are available in a wide range of filtration areas from 4.5 cm² up to 3.0 m² and with a variety of commonly used connections to ensure easy integration into your process regardless of batch size.
Scale Up:
Due to the identical performance data of the different heights in relation to square meters of filter area, Sartopore® Platinum filters are perfectly scalable from small scales to large production scales.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Microbial Retention
Sartopore® Platinum filters are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.
Documentation:
Sartopore® Platinum filter filters have been designed, developed and produced in accordance with the ISO 9001 certified quality management system. A validation manual is available in accordance with regulatory requirements.

Specifications
Applications:
Application: Single Use Processing
Industry: Pharma / Biotech
Modality: Buffer & Auxiliaries Filtration; Form & Fill
Scale: Production | Large Scale

Biological Information:
Bacterial Retention: Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

Compliance Information:
Bacterial Endotoxins: < 0.25 EU/mL as determined by the LAL test
Biological Reactivity: All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
Extractables: The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".

Connections (Physical):
Connector Inlet: 1.5" Tri-clamp 50.5 mm
Connector Outlet: 1.5" Tri-clamp 50.5 mm
Connector(s): Inlet: 1 ½" Sanitary | Outlet: 1 ½" Sanitary

Dimensions:
Filter Size: 10"(1.0 m² / 10.8 ft²)
Filtration Area: 1 m²
Outer Diameter: 164 mm (110.4 mm without Connection / Valves)

General Specifications:
Capsule/Cartridge Format: T-Style Maxicaps®
Filter Format: Capsules
Maximum Allowable Back Pressure: 2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
Maximum Diffusion: 25 mL/min at 2.5 bar | 36 psi
Minimum Required Bubble Point: 4.1 bar | 59.5 psi
Vent Valve: Standard

Materials of Construction:
Filter Material: Polyethersulfone (PES)
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Polyethersulfone, Hydrophobic (PES)

Operating Conditions:
Maximum Differential Pressure: 20 °C: 5 bar, 50 °C: 3 bar
Maximum Operating Pressure: 5 bar (72.5 psi)

Physicochemical Information:
Non-Fiber Releasing: This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
Pore Size Final-filter: 0.2 µm
Pore Size Pre-filter: 0.45 µm

Product Information:
Brand: Sartopore® Platinum HB
Pack Size: 1
Type: T-Style (Autoclavable | γ-irradiatable)

Sterility/Purity:
Delivery Condition: Sterile - Autoclaved
Sterilization Method: Autoclavable & Gamma Irradiatable