Sartorius, 5442558M2, Sartopore® 2 XLM | Cartridge | 0.1µm | 20"

Effective Filtration Area: 1.6 m² | 17.2 ft²
Pore Size: 0.2 µm prefilter | 0.1 µm final filter
Membrane Material: Polyethersulfone
Sterilization: In-line steamable | Autoclavable
Adapter: 2-Flange Bayonet | 226 Double O-ring
O-ring material: Silicone

Sartopore® 2 XLM is specifically designed for sterile filtration and safe mycoplasma retention in cell culture media. A long filter life is guaranteed by the extremely asymmetrical and heterogeneous PES Membrane and allows a >50% better performance compared to existing 0.1 μm filter cartridges.
Lowest filter consumption by high filtration capacity
Lowest risk of Mycoplasma contamination for your fermentation process
High performance 0.1 μm Mycoplasma retentive filter
Fully validated as sterilizing-grade filter (according to current ASTM F-838 guideline)
Main Applications
Focus applications include:
Cell culture media containing vegetable peptone, soy or yeast
Serum containing cell culture media
Cell Culture Media Components
All other cell culture media used in biotechnical production
Your Benefits
Increased total throughput leads to less filter consumption, less process interruptions and reduced costs
Increased effective filtration enables the use of smaller filters to reduce footprint and waste
Proven and robust membrane chemistry known from the widely established Sartopore® 2 family lowers validation effort in case of process optimization
Broad range of formats and sizes assures scalability and enables use of Sartopore® 2 XLM along the whole drug product lifecycle: from development to commercial processes
Offers secure bacterial retention according to ASTM guidelines
The XL family
The XL in its name indicates an increased effective filtration area (EFA). By using a different pleating technology, the EFAs of Sartopore ® 2 XLM filters are - depending on filter format - 30-40% higher than for the conventional Sartopore® 2 filters. This leads to higher total throughput per filter element and less filter consumption or enables the use of a smaller filter element for a process to reduce the footprint and waste.
Membrane
Sartopore® 2 XLM uses a heterogeneous double membrane made of polyethersulfone
Compatibility
Sartopore®2 XLM Cartridges have been developed for sterilization using either autoclaving or in-line-steaming. The polyethersulfone membrane used is suitable for the filtration of liquids in the pH range of pH 1-14.
Economical Filtration
The built-in pre-filter membrane is specially designed to protect the 0.1 μm membrane in cell culture media filtration. The optimized membrane combination together with the exceptionally high filter area of 0.8m²/10'' filter element allow a >50% better performance compared to existing 0.1 μm filter elements, which ensures low filtration costs per litre, minimized filtration times and smallest footprint of the filtration system.
Flexibility
Sartopore® 2 XLM 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 performed safely because all Sartopore® filter elements are manufactured with the same membrane type and construction materials.
Quality:
Every single element is tested for integrity to meet the highest quality requirements.
Microbial Retention
Sartopore® 2 XLM filter cartridges are validated as sterile filter cartridges according to HIMA and ASTM F-838-05 guidelines.
Documentation:
Sartopore® 2 XLM 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
Accessories Information:
Adapter: Bottom: 2-Flange Bayonet w. 226 double o-ring | Top: S-Adapter

Applications:
Application: High capacity platform for conventional sterile filtration
Industry: Pharma / Biotech
Modality: Media 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".

Dimensions:
Filter Size: 20"(1.6 m² / 17.2 ft²)
Filtration Area: 1.6 m²
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: 78 mL/min

Materials of Construction:
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Polyethersulfone (PES)
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: 0.1 µm
Pore Size Pre-filter: 0.2 µm

Product Information:
Brand: Sartopore® 2 XLM
Pack Size: 1

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