Sartorius, 5107307H1--SO, Sartolon | Maxicaps® | 0.2µm | 10"

Effective Filtration Area: 0.6 m² | 6.5 ft²
Pore Size: 0.45 µm prefilter | 0.2 µm final filter
Membrane Material: Polyamide (Nylon)
Connectors: Inlet: Sanitary 1 ½“| Outlet: Hose Barb ½“ single stepped
Sterilization: Delivered sterile (Autoclaved)
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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.
Cost savings:
The use of disposable filter elements eliminates the need to invest in stainless steel filter housings. Additional costs for housing cleaning and cleaning validation are eliminated.
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.
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.

Specifications
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: Standard

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
Type: 10" | Connectors: SO

Sterility/Purity:
Delivery Condition: Sterile - Autoclaved
Sterilization Method: Autoclavable

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