Sartopore® Platinum HB | Sartoscale 47 | 0.2µm | 3pc.

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

SartoScale units are ideally suited for all types of filterability studies with the aim of selecting the optimal prefilter for an optimal application. Moreover, they can determine the ideal combination of pre- and final filters with the aid of a minimum product volume.

• Developed for the execution of reliable filterability samples
• Made from the same non-woven fabric material as the original filter cartridges
• Ready-to-use single-use test filter unit

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.

SartoScale units contain the original filter active material of the corresponding filter cartridges to ensure the repeatability of test results.

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.

Flexibility

Sartopore^® Platinum filters are available in different sizes and formats with corresponding filter areas from 4.5 cm² up to 3 m². Different connections allow easy integration into existing systems.

Using SartoScale during filtration studies saves time which would otherwise be used for the installation preparations for the punch piece in the stainless steel filter brackets and prevents possible installation errors.

After the material selection or the definition of a pre/final filter combination with the SartoScale units, a scale-up method should be carried out for the flow rate and total flow using pleated capsule units of small scales (e.g. capsule size 4).

SartoScale units have an extremely low residual volume for performing filterability samples with minimized product volumes.

SartoScale test filter units are equipped with suitable filter membranes for integrity testing so that their integrity can be determined using the bubble point test in order to ensure absolute reliability of the test results.

We recommend using the SartoScale units together with the Zero-T Filter Test System to make the filtration studies as effective as possible. The Zero-T system consists of hardware and software modules which make it easy to handle and install Sartoscale test filter units. Automatic data collection is achieved by connecting a frame to a laptop. The software automatically analyzes the incoming data for the scale-up calculations.