• Effective Filtration Area: 0.6 m² | 6.5 ft²
  • Pore Size: 0.45 µm prefilter | 0.2 µm final filter
  • Membrane Material: Polyamide (Nylon)
  • Sterilization: Delivered non-sterile: In-line steamable | Autoclavable
  • Adapter: 2-Flange Bayonet | 226 Double O-ring
  • O-ring material: Silicone

Filter Size
Material o-ring | seal
Adapter
Price (USD):
$452.00
Item No.: 
5102507H1
Availability: 
Piece
1

*Custom/bulk order quotes are provided within 72 hours of request.

Tutorial

Filter Cartridges & Capsules Product Tutorial

Watch our video tutorial to discover the essential steps for sterile filtration and master the sterilizing-grade filtration process.

Watch Training Video

Featuring a unique hydrophilic nylon (polyamide) membrane, Sartolon filters offer mechanical strength and broad chemical compatibility. They are the ideal choice for sterile filtration of solvents and oily formulations where chemical stability is needed.

In addition to its wide range of applications, Sartolon filters provide outstanding total throughput and flow rates due to their heterogeneous double-nylon layer. The enhanced filtration performance guarantees process efficiency, reduces filtration costs and leads to short filtration cycles.

Main Applications

  • Solvents & Oily Formulations
  • Antibiotics
  • Large Volume Parenterals
  • Bulk Pharmaceutical Chemicals
  • ADCs

Benefits

  • High chemical compatibility for the filtration of solvents
  • High filter capacity by in-built pre-filter (double-layer construction)
  • Excellent performance for oily formulations
  • Highly economic solution e.g. for antibiotics processes

Membrane

Sartolon uses a double-layer membrane made of polyamide. The "built-in pre-filtration" results in the highest possible total flow, so that a filter change during filtration is avoided. The membrane is reinforced with a PET fleece.

Flexibility

Sartolon filters are available in a wide range of filtration areas from 4.5 cm² up to 2.4 m² and with a variety of commonly used connections to ensure easy integration into your process regardless of batch size.

Scale Up:

Consistent and predictable scale-up and scale-down procedures can be safely performed because all Sartolon filter elements are manufactured with the same membrane type, support fleeces and construction materials.

Sterilization

Sartolon filters have been developed for sterilization using autoclaving at 134°C | 2bar or in-line-steaming.

Quality:

Every single element is tested for integrity to meet the highest quality requirements.

Documentation:

Sartolon 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.

Accessories Information

  • Adapter
    Bottom: 2-Flange Bayonet w. 226 double o-ring | Top: S-Adapter

Applications

  • Application
    Filtration of antibiotics and organic solvents
  • Modality
    Buffer & Auxiliaries Filtration

Biological Information

  • Bacterial Retention
    Quantitative Retention of 1 × E7 CFU/cm² Brevundimonas Diminuta ATCC® 19146 per ASTM methodology

Compliance Information

  • Bacterial Endotoxins
    < 0.25 EU/mL as determined by the LAL test
  • Biological Reactivity
    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".

Connections (Physical)

  • Connector Inlet
    2-Flange Bayonet Adapter with 226 Double O-ring (25)
  • Connector Outlet
    2-Flange Bayonet Adapter with 226 Double O-ring (25)

Dimensions

  • Filter Size
    10"(0.6 m² / 6.5 ft²)
  • Outer Diameter
    70 mm

General Specifications

  • Capsule/Cartridge Format
    Cartridges
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1 bar (14.5 psi) at 80°C
  • Maximum Diffusion
    13 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.0 bar | 43.5 psi
  • Vent Valve
    N/A

Materials of Construction

  • Filter Material
    Nylon (NY)
  • Housing Material
    Polypropylene (PP)
  • Material o-ring | seal
    Silicone (SI)
  • Membrane Material
    Polyamide (PA/NY)
  • Support Fleece
    Polypropylene (PP)

Operating Conditions

  • Maximum Differential Pressure
    20 °C: 5 bar, 80 °C: 2 bar

Physicochemical Information

  • 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.
  • Pore Size Final-filter
    0.2 µm
  • Pore Size Pre-filter
    0.45 µm

Product Information

  • Brand
    Sartolon
  • Pack Size
    1
  • Type
    Cartridge | 10"

Sterility/Purity

  • Delivery Condition
    Non sterile - Autoclavable | Steamable
  • Sterilization Method
    Autoclavable & In-Line Steam Sterilizable

Usage Protocols

  • Sterilization Procedures
    • In-Line Steam Sterilization: at 134 °C, 20 min., 0.5 bar, min. 25 Cycles
    • Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles