Sartorius, 5197307A1G-SSIT, Sartopore® Air Gamma Maxicaps® Size 1 IT

Sartopore® Air Maxicaps® Size 1 IT (Integritiy testable) filters, with a 0.53 m² filtration area and a hydrophobic 0.2 µm PES membrane, ensure sterile air filtration for large-scale biopharmaceutical applications. The IT variant includes a vent valve for connecting Sartocheck®.

Sartopore® Air Maxicaps® Size 1 IT (IT = Integrity testable)
Product Information:
Sartopore® Air Maxicaps® Size 1 IT filters are specifically designed to meet the demanding requirements of large-scale biopharmaceutical applications, providing efficient and reliable sterile air filtration solutions. These filters are equipped with hydrophobic 0.2 µm polyethersulfone (PES) membranes, ensuring effective particle retention and compliance with industry standards. The IT variant includes a vent valve for connecting Sartocheck®, enhancing process security and efficiency.
Format:
Maxicaps® Size 1 IT: Featuring a filtration area of 0.53 m², these filters are ideal for large-scale processes requiring efficient sterile air filtration and integrated testing capabilities.
Applications:
Storage Vents: Provides reliable venting solutions for mixing and storage bags, maintaining sterility and process integrity.
Fill-Finish Assemblies: Supports exhaust filtration in fill-finish processes, ensuring compliance and product quality.
Large-Scale Bioreactors: Ensures sterile air filtration for optimal cell growth and process efficiency in large-scale bioreactor setups.
Integrated Testing: The IT variant allows for easy connection to Sartocheck® for integrity testing, ensuring reliable performance.
Materials Used:
Membrane: Hydrophobic PES membrane for efficient air flow and particle retention.
Housing: Durable polypropylene construction for robust performance in biopharmaceutical environments.
O-Rings: Silicone materials ensuring secure sealing and compatibility with various sterilization methods.
Advantages:
Efficient Filtration: Hydrophobic PES membrane ensures effective sterile air filtration and high flow rates.
Reliable Retention: Proven retention capabilities for bacteria, phages, and particles, meeting stringent regulatory standards.
Quality Assurance: 100% factory integrity testing guarantees performance reliability and traceability.
Large Filtration Area: The 0.53 m² filtration area is ideal for large-scale applications, offering flexibility and efficiency.
Integrated Testing Capability: The vent valve for connecting Sartocheck® facilitates easy integrity testing, enhancing reliability.
Robust Construction: Durable materials ensure compatibility with biopharmaceutical environments and processes.
Convenient Sterilization: Compatible with gamma irradiation, simplifying integration into existing workflows.
Sartopore® Air Maxicaps® Size 1 IT filters offer a comprehensive solution for sterile air filtration in large-scale biopharmaceutical applications, ensuring process security and efficiency. Explore the range of applications to find the perfect fit for your needs. For more information visit the Sartopore® Air webpage.

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).

Connections (Physical):
Connector Inlet: 1.5" Tri-clamp 50.5 mm
Connector Outlet: 1.5" Tri-clamp 50.5 mm
Connector(s): 1.5" Tri-clamp 50.5 mm | 1.5" Tri-clamp 50.5 mm

Dimensions:
Filter Size: 10"(0.53 m² / 5.7 ft²)
Filtration Area: 0.53 m² | 5.7 ft²

Features:
Venting Filter: Yes

General Specifications:
Capsule/Cartridge Format: Maxicaps®
Vent Valve: IT Compatible

Materials of Construction:
Filter Material: Single-layer polyethersulfone (PES) membrane
Housing Material: Polypropylene (PP)
Material o-ring | seal: Silicone (SI)
Membrane Material: Polyethersulfone, Hydrophobic (PES)

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

Product Information:
Brand: Sartopore® Air
Pack Size: 1

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

Usage Protocols:
Sterilization Procedures: Gamma irradiation with max. 50 kGy.