Product Information
Sartofluor® has been synonomous with reliable air | gas filtration for decades. Employing the proven single-layer ePTFE membrane technology, this latest addition to the Sartofluor® broad offering of filter cartridges is specifically designed for long-term, high-temperature applications, such as Water For Injection (WFI) loop venting. Bacterial, phage and particle retention validation make Sartofluor® HR a valuable addition to the Sartofluor® product family.
Designed for High Temperature Applications
Sartofluor® HR filter cartridges can be used for an extended time period of at least six months at a temperature of 90°C. Incorporating the proven hydrophobic 0.2 μm Sartofluor® ePTFE membrane (sterilizing grade according to current ASTM F-838 guideline), Sartofluor® HR also provides a validated retention of particles (sizes 0.005 μm | 0.3 μm), which is of the utmost importance for these types of applications. Integrity testing by Water Intrusion Test (WIT) allows in-situ integrity testing and circumvents the use of alcohol for wetting. Multiple in-line steaming | autoclaving cycles can be conducted without any loss of performance.
Applications
- Water For Injection (WFI) tanks | loops (80 – 90°C)
- Autoclaves
- Permanently heated filter housings
- All applications where hot air (approx. 90°C) is used over long periods
Inherent Quality Provides Full Confidence
The 0.2 μm hydrophobic ePTFE membrane is self dewetting and, therefore, provides high air flow rates even at very low differential pressures over an extended process time.
Validated by various retention tests, Sartofluor® HR filter cartridges ensure sterile filtration of air | gas.
The following indispensable requirements are fulfilled:
- Retention of ≥ 107Brev. diminuta/cm2
- Retention of ≥ 107 Bacteriophage MS2/cm2
- Retention of particles: sizes 0.005 μm | 0.3 μm
- Clear labeling with filter type, lot number, individual unit serial number, 2D data matrix code
- Developed, produced and distributed under a quality management system certified to DIN/ISO 9001
- USP Plastic Class VI Test
Sterilization
In-Line Steam Sterilization: 134°C, 30 min. at max. differential pressure of 0.5 bar | 7.25 psi in forward and reverse direction, min. 100 sterilization cycles
or Autoclaving: 134°C, 2 bar, 30 min, min. 100 sterilization cycles*
*Note = No tests are conducted beyond the specified sterilization cycles; Sartorius is not liable for any additional cycles initiated by the customer.
