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Sartofluor® MidiCaps®

Sartofluor® is the solution for all applications where sterile air is needed. A single-layer PTFE membrane construction ensures validated sterility, while providing maximum flow rate over a wide range of operating conditions. The optimal performance-to-cost ratio allows benefiting from the lowest cost-of-ownership for air/gas and aggressive solvent filtration.

Order Number:  5185307T0--SS--V

Availability:  On Request

Sartofluor® are sterilizing grade air & gas filters that utilize Polytetrafluorethylene (PTFE) membranes. PTFE is a chemically extremely resistant membrane material which is also suitable for highly aggressive solvents. The optimized construction leads to a perfect hydrodynamic flow.

Requirements of Air/Gas Filtration

The air filter as a barrier needs to be highly reliable under all circumstances, i.e. pressure pulses, high steaming cycles, elevated moisture content etc. That’s why we optimized our Sartofluor® air filter cartridges to meet all the requirements with highest assurance levels.

  • Highest hydrophobicity
  • High flow rates at low differential pressures
  • High steam cycle lifetimes
  • High mechanical and thermal strength
  • Reliable and validated separation of microorganisms and bacteriophage

User-Optimized

The development of this extremely reliable, secure, “last chance” barrier filter included the experiences of our Research and Development, engineering groups, suppliers, and especially our customers. Their input was and is our most valuable resource to find the optimum performance.

Optimum choice for sterile venting and gas applications

  • Sterile gas filtration of fermenter inlets
  • Off-gas filters downstream of fermenters or bioreactors
  • Sterilizing vent filters on autoclaves and Iyophylizers (freeze dryer)
  • Sterile vent filters on product tanks
  • Sterile air supply for service gases, such as filling lines in blow-fill-seal machines

Sartofluor® cartridges are available in the optimum range of pore sizes – 0.45 µm, 0.2 µm and 0.1 µm.

Dependable performance at every scale

Our scale-up philosophy does not stop at liquid filtration. Especially in air filtration, with its variety of applications and demands, different filter sizes are essential. Sartofluor® filter cartridges are available from 300 m² to 2.3 cm² for single filter elements, which means you can effectively filter air from small volume bioreactor to seed and large scale fermenter venting, as well as tank venting.

The right hydrophobicity

If the filter membrane is not hydrophobic enough, moisture can accumulate and microorganisms may grow. A highly hydrophobic membrane can eliminate this danger along with any risk of water logging. Sartofluor membranes are constructed of PTFE. It provides more than twice the hydrophobicity of polypropylene or PVDF.

Optimized construction adds savings

Experience, testing and customer feedback have guided the evolution of Sartofluor cartridges. For example, membrane pleatings and layers of filter fleece have been chosen to avoid water logging. Attention to detail at this level means you realize added savings in low blow down times.

Mechanical strength and optimized construction

We‘ve tested Sartofluor cartridges to 134°C and they all withstood 150 steam cycles. No loss in integrity or performance. Or in PTFE hydrophobicity. No loss in flow rate. Plus, optimized Sartofluor cartridge construction allows differential pressures up to 0.5 bar at 134°C. This exceptional performance has been confirmed by Bacterial Challenge testing.

No water blockage. High flow rates. Maximum savings.

In air filtration applications, high flow rates result in lower energy costs and help to maximize safety – for example, for tank, venting. Sartofluor® cartridges are optimized to maintain high flow rates, even in challenging process conditions like condensate build-up in steam-venting or elevated moisture content. No cartridge does more to control life-cycle costs. No cartridge system is more cost-effective. The Reason: Sartofluor® PTFE membrane and support fleece are extremely hydrophobic and feature optimized pleat density. The Result: effective drainage of condensate and no water blockage.

Validated performance for assured security

Sartofluor® cartridges fulfill all known current regulatory requirements, for example USP, cGMP and FDA. This is documented in our Validation Guidelines for Sartofluor filter cartridges. Besides the validation, Sartofluor® cartridges undergo a stringent performance qualification procedure:

  • They’re pressure-pulsation tested for 5000 cycles at 5 bar differential pressure.
  • They’re steam-cycle evaluated for 150 cycles at 134°C for 30 min; then 11 additional cycles over 7 hours.
  • Their flow rate and water penetration are measured only after defined steam cycling.
  • They’re tested at maximum allowable differential pressure at a full range of temperatures.
  • Their blow-down time is measured after steam sterilization and Water Intrusion Testing.
  • They pass extractable tests done using RP-HPLC, GC-MS and FTIR.
  • They pass phage challenge tests that last as long as 7 days.

Brochure

Sartofluor® PTFE Filter Cartridges — Scalable and secure performance in sterile venting
en 2.0 MB

Datasheet

Sartofluor® MidiCaps® and Capsules
en 136.3 kB

Product properties

  • Capsule/Cartridge Format
    MidiCaps®
  • Filter Size
    size 0 (0.45 m² / 4.8 ft²)
  • Material o-ring | seal
    Silicone (SI)
  • Filtration area
    0.45 m²
  • Height
    330 mm
  • Pore size final-filter
    0.2 µm
  • Connector Outlet
    1 ½" Tri-Clamp 50 mm
  • Connector Inlet
    1 ½" Tri-Clamp 50 mm

Technical attributes

  • Sterilization Procedures
    Autoclaving=== Min. 25 cycles at max. 134 °C, 2 bar | 29 psi, 30 min.
  • Sterilization Method
    Autoclavable
  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • Bacterial Retention
    Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology
  • GMP Compliance
    This product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.
  • Maximum Differential Pressure
    20 °C=== 5 bar; 50 °C=== 3 bar
  • Biosafety
    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".
  • 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.
  • Housing material
    Polypropylene (PP)
  • Support Fleece
    Polypropylene (PP)
  • Overall length
    Connector Combinations SS & FF=== 0.05 m² | 0.5 ft²=== 115 mm; 0.1m² | 1 ft²=== 148 mm; 0.2 m² | 2 ft²=== 197 mm; 0.45 m² | 5 ft²=== 330 mm
  • Min. required Bubble Point
    1.0 bar
  • Max. diffusion
    8 mL/min at 0.7 bar
  • Industry
    Pharma/Biotech