Sartopore® Platinum HB | Gamma Midicaps® | 0.2µm | Size 0 | 2pc.

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

Application

Typical filtration applications include:

• Therapeutica
• Biological Fluids
• Injection solutions
• Media
• Buffer
• Chemical solutions
• Cleaning agents and disinfectants

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^®Platinum filters have been developed for sterilization using 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 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.