Sartolon | Maxicaps® | 0.2µm | 10" | IT Valve

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Sartolon | Maxicaps® | 0.2µm | 10" | IT Valve Sartolon | Maxicaps® | 0.2µm | 10" | IT Valve Sartolon | Maxicaps® | 0.2µm | 10" | IT Valve Sartolon | Maxicaps® | 0.2µm | 10" | IT Valve
 

Designed for large-scale production, Sartolon Maxicaps® deliver exceptional filtration performance with a robust nylon membrane, supporting high throughput and cost-effective processing of bulk pharmaceuticals.

Filter Size
Connector(s)
Vent Valve
Price (USD)
$606.00
Item No.: 
5107307H1--SOIT
Piece
1
*Custom/bulk order quotes are provided within 72 hours of request.
Sartolon | Maxicaps® | 0.2µm | 10" | IT Valve
Sartolon | Maxicaps® | 0.2µm | 10

Designed for large-scale production, Sartolon Maxicaps® deliver exceptional filtration performance with a robust nylon membrane, supporting high throughput and cost-effective processing of bulk pharmaceuticals.

Price (USD):
$606.00
Item No.:
5107307H1--SOIT
Number of pieces
1

Overview

Specifications

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Sartolon® Nylon Sterile Filtration

Sartolon® filters use a hydrophilic nylon membrane to deliver sterilizing-grade performance for solvents and oily formulations. Their robust construction and chemical compatibility support reliable filtration from process development to production.

Key Features

  • Hydrophilic Nylon Membrane: Provides strong chemical compatibility with solvents and oily formulations, while mechanical strength supports stable flow and durability.
  • Double-Layer Design: Heterogeneous double-layer nylon architecture enhances throughput and helps limit early blockage for efficient, high-volume processing.
  • Scalable Areas And Formats: Membrane areas from 4.5 cm² to 2.4 m² across different formats enable linear scale-up with aligned performance.
  • Integrity and Compliance: Elements are integrity testable and manufactured to meet WFI quality and non-pyrogenic requirements, supporting robust qualification.
  • Consistent Performance: Materials and construction deliver dependable filtration across varied process fluids, helping maintain line utilization.

Applications

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

Benefits

  • High Throughput: Double-layer architecture supports high flow at relevant differential pressures, helping shorten filtration cycles and improve productivity.
  • Broad Fluid Compatibility: Hydrophilic nylon enables reliable performance with solvents and oily formulations, expanding applicability across unit operations.
  • Reliable Qualification: Integrity-testable design supports reproducible release criteria and consistent process control in development and manufacturing.
  • Cost-Efficient Processing: Enhanced throughput and stable flow can reduce filter consumption and overall processing costs while sustaining performance.
  • PFAS: Made without intentionally using PFAS compounds.

Applications

  • Application
    Filtration of antibiotics and organic solvents
  • Modality
    Buffer & Auxiliaries Filtration
  • Scale
    Production | Large Scale

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
    1.5" Tri-clamp 50 mm
  • Connector Outlet
    1/2" Single Stepped Hose Barb
  • Connector(s)
    Inlet: 1 ½" Sanitary | Outlet: ½" Hose Barb

Dimensions

  • Filter Size
    10"(0.6 m² / 6.5 ft²)
  • Outer Diameter
    137 mm (110 mm without Connection / Valves)

General Specifications

  • Capsule/Cartridge Format
    Maxicaps®
  • Maximum Allowable Back Pressure
    2 bar (29 psi) at 20°C; 1.5 bar (21.8 psi) at 50°C
  • Maximum Diffusion
    13 mL/min at 2.5 bar | 36 psi
  • Minimum Required Bubble Point
    3.0 bar | 43.5 psi
  • Vent Valve
    IT Compatible

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, 50 °C: 3 bar
  • Maximum Operating Pressure
    5 bar (72.5 psi)

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

Sterility/Purity

  • Delivery Condition
    Sterile - Autoclaved
  • Sterilization Method
    Autoclavable

Usage Protocols

  • Sterilization Procedures
    Autoclaving: at 134°C, 30 min, 2 bar, min. 25 Cycles