Sartofluor® GA Midicaps® 0.2 µm Size 0

Product Information

Sartofluor® is especially suited to demanding venting applications with high volume gas streams, extreme humidity, and stringent Steam In Place regimes. The hydrophobic PTFE membranes used in Sartofluor® filters offer reliability, process security, and a long service life.

Introduction

The Sartofluor® family of filters has been on the market for over three decades and has improved over time in response to changing customer needs. Today, experience and filtration expertise are combined in our best sterile venting device ever. Sartofluor® contains PTFE membrane making it the most hydrophobic vent filter available. The inherent hydrophobicity of the PTFE membrane is unaffected by repeated autoclaving or steaming and guarantees sterile filtration of both dry and moist gases. Sartofluor® filters show superior air flow rates throughout all sizes and formats.

Applications

• Bioreactors (Inlet | Outlet)
• Storage Tank Venting
• Filling Equipment Venting
• Freeze Dryer Autoclave Venting

Benefits

The Most Reliable Sterile Venting Device

The 0.2 μm single-layer hydrophobic PTFE membrane offers superior moisture repellence and exceptional gas flow rates at low differential pressures.

All components were developed and are produced under the full control of Sartorius. In addition, the following critical requirements are met:

• Retention of ≥ 10⁷ B. diminuta/cm² in aerosol and liquid
• Retention of ≥ 10⁷ MS2 coliphage/cm² in aerosol
• Retention of particles sizes 0.005 μm | 0.3 μm
• Bi-directional sterility proven by worst case liquid Bacterial Challenge Test in forward and reverse direction
• 100% integrity tested prior to release
• Clear labelling with Lot. number and individual unit number. All information laser marked on each filter housing.

Regulatory Compliance

• Each individual element is tested for integrity by Bubble Point and Diffusion test
• Fully validated as sterilizing grade filters according to current ASTM F-838 guidelines
• Designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System
• USP Plastic Class VI Test
• Non-fiber releasing: This product was manufactured with a membrane which meets the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3 (b) (6) and 211.72.
• Oxidizable Substances: The filtrate of these filter elements shows a negative reaction when tested according to the current USP