Sartorius, 17805--------AIE, Sartopore® Air Midisart®

Sartopore® Air Midisart® offers sterilizing-grade venting with a hydrophobic 0.2 µm PES membrane, ideal for bioreactors and storage tanks. It ensures reliable particle retention, regulatory compliance, and versatile sterilization options, enhancing biopharmaceutical processes.

Sartopore® Air Midisart®
Product Information:
The Sartopore® Air Midisart® is a single-use venting filter featuring a hydrophobic 0.2 µm polyethersulfone (PES) membrane with a filtration area of 20 cm². It is designed for critical applications, providing effective sterilizing-grade venting in both directions. The filter excels in particle and bacteria retention, with rigorous integrity testing conducted before use.
Formats:
Standard Format: Available in various packaging sizes to suit different operational needs, including 12, 100, and 500 units per package.
Sterilization Options: Offered in gamma-irradiatable or autoclavable versions, providing flexibility in sterilization methods.
Applications:
Bioreactors: Ideal for small-scale bioreactors, ensuring sterile air exchange and preventing contamination.
Carboys and Storage Tanks: Suitable for venting applications in carboys and storage tanks, maintaining sterility during storage and transfer.
Transfer Vessels: Maintains sterile conditions during the transfer of liquids, preserving product integrity.
Materials Used:
Membrane: Hydrophobic 0.2 µm polyethersulfone (PES) membrane, known for its excellent particle retention and sterilizing capabilities.
Construction: Lightweight design prevents tubing kinking, and the absence of fleeces eliminates particle release.
Advantages:
Reliable Sterilizing-Grade Performance: Ensures bi-directional sterility and effective particle retention.
Regulatory Compliance: Clear laser labeling and adherence to USP Plastic Class VI and ASTM F-838 standards.
High Reliability: Each filter undergoes 100% factory integrity testing, providing full confidence in its quality.
Efficient Design: Lightweight construction prevents tubing kinking, enhancing ease of use.
Versatile Sterilization Options: Available in gamma-irradiatable or autoclavable versions for efficient and reliable operations.
Cost-Effective Solution: Offers a balance of performance and cost, making it an ideal choice for various applications.
The Sartopore® Air Midisart® is designed to meet the demanding needs of the biopharmaceutical industry, providing a reliable and efficient solution for venting applications. Its advanced design and materials ensure optimal performance, making it a valuable addition to any biopharmaceutical process. For more information or to place an order, please visit our e-Shop or contact us directly.

Specifications
Applications:
Application: Air/Gas Filtration
Application Area: Single-use bioreactors (Sparge | Overlay filter assemblies | Exhaust filter assemblies); Single-use mixing and storage bag vents; Single-use liquid filter assemblies requiring PUPSIT (Post Sterilization Pre-Use Integrity Testing); Fill-finish
Industry: Pharma / Biotech

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
Biocompatibility (USP Class VI): USP <88>
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: Hose Barb 6–12 mm Stepped
Connector Outlet: Hose Barb 6–12 mm Stepped

Dimensions:
Filter Size: 20 cm² / 3 in²
Filtration Area: 20 cm² / 3 in²

Features:
Venting Filter: Yes

General Specifications:
Capsule/Cartridge Format: Midisart®
Minimum Required Bubble Point: > 950 mbar | 13.8 psi

Materials of Construction:
Filter Material: Single-layer polyethersulfone (PES) membrane
Housing Material: Polypropylene (PP)
Membrane Material: Polyethersulfone, Hydrophobic (PES)

Operating Conditions:
Maximum Differential Pressure: 2 bar
Maximum Operating Pressure: 2 bar (29 psi)

Physicochemical Information:
Gamma Stable: Yes
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: 0.2 µm
Pore Size Final-filter: 0.2 µm

Product Information:
Brand: Sartopore® Air
Pack Size: 12
Packaging: Non-sterile, bulk packed
Type: Air filter

Sterility/Purity:
Delivery Condition: Non sterile - Gamma irradiatable
Sterilization Method: Autoclavable & Gamma Irradiatable
Sterilizing Grade: Yes

Usage Protocols:
Sterilization Procedures: Gamma irradiation with max. 50 kGy.; Autoclaving: max. 134°C temperature for 30 min. (max. 20 cycles)