Sartorius Lab Instruments GmbH & Co. KG Sartopore® 2 XLI MaxiCaps® 0.2 µm Liquid Filters 5441307I2--**

Sartopore® 2 XLI MaxiCaps are especially designed for sterilizing grade filtration of pharmaceutical solutions with a homogenous particle spectrum. The unique heterogeneous double layer PES membrane combination of Sartopore® 2 XLI MaxiCaps is specifically developed to provide exceptional high total throughputs and outstanding flow rates for totally chemically defined process fluids and other process fluids of biotech manufacturing processes with small particle spectrum. Applications: Typical applications of Sartopore® 2 XLI MaxiCaps include sterilizing grade filtration of: – Ophthalmic solutions – Chemically defined cell culture media – High viscous large volume parenterals – Any fully chemically defined media. Economy: The combination of the build in 0.35 µm pre-filter in front of a 0.2 µm final filter together with an exceptionally high effective filtration area of 0.8 m²/10” MaxiCap provide outstanding total throughput and flow rate performance in the target applications. Thus ensuring highest process efficiency, minimized filtration costs and short filtration cycle times. Compatibility: The PES membrane of Sartopore® 2 XLI MaxiCaps provides broad chemical compatibility from pH 1 to pH 14 and low extractable levels. They are compatible with multiple autoclaving cycles up to 134°C. Scalability: Sartopore® 2 XLI filter elements are available in a broad range of sizes and formats to provide linear scale-up from R&D to process scale. Microbiological Retention: Sartopore® 2 XLI MaxiCaps are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartopore® 2 XLI MaxiCaps are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Applications: Typical applications of Sartopore® 2 XLI MaxiCaps include sterilizing grade filtration of: Ophthalmic solutions Chemically defined cell culture media High viscous large volume parenterals Any fully chemically defined media Economy: The combination of the build in 0.35 µm pre-filter in front of a 0.2 µm final filter together with an exceptionally high effective filtration area of 0.8 m²/10” MaxiCap provide outstanding total throughput and flow rate performance in the target applications. Thus ensuring highest process efficiency, minimized filtration costs and short filtration cycle times. Compatibility: The PES membrane of Sartopore® 2 XLI MaxiCaps provides broad chemical compatibility from pH 1 to pH 14 and low extractable levels. They are compatible with multiple autoclaving cycles up to 134°C. Scalability: Sartopore® 2 XLI filter elements are available in a broad range of sizes and formats to provide linear scale-up from R&D to process scale. Microbiological Retention: Sartopore® 2 XLI MaxiCaps are fully validated as sterilizing grade filters according to HIMA and ASTM F-838-05 guidelines. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to be released assuring absolute reliability. Documentation: Sartopore® 2 XLI MaxiCaps are designed, developed and manufactured in accordance with an ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements.