Sartorius Sartobran® P 0.65 + 0.45 Mic Filter Midicaps® 5235306d8--oo--a 4/pack

US $99.00

  • Oceanside, California, United States
  • Jan 30th
Description MidiCaps® are the innovative, all new disposable capsule plattform technology from Sartorius. MidiCaps® focus on design improvements of the capsule housing to permit the use of filter capsules in aseptic processing. MidiCaps® are available for all existing filter media from Sartorius. Sartobran® P membrane filter MidiCaps® 0.45 ?m rated are ideally suited for bioburden and defined particle reduction from bio-pharmaceutical solutions. They can be used for protection of sterilizing grade membrane filters or subsequent downstream processing equipment in biotech production processes.The unique low unspecific binding capacity of the cellulose acetate membranes assures highest protein yield and rapid preservative recovery. Sartobran® P filters are ideally suited for prefiltration of high value biological solutions and pharmaceuticals sensitive to adsorption as well as for final filtration of LVP?s and Buffers. Due to the "built-in prefiltration" by a 0.65 µm membrane, Sartobran® P 0.45 µm filters provide excellent total throughputs and higher flow rates at low differential pressure for gentle product treatment. MidiCaps® are designed, developed and manufactured in accordance with the ISO 9001Certified Quality Management System. Each individual element is tested for integrity by Diffusion- and Bubble-Point-test prior to being released, assuring absolute reliability. A Validation Guide is available for compliance with regulatory requirements. Applications: Featuring extremely low adsorptive cellulose acetate membranes, Sartobran P filter elements are ideally suited for filtration of highly valuable protein solutions or solutions containing preservatives. They assure highest protein yield and rapid preservative recovery. Typical applications include: Coagulation Factors, Albumin, IgG Bacterial and Viral Vaccines MAB Bio-processed Pharmaceuticals Diagnostics Purified Protein Solutions Biological Fluids Fluids containing preservatives Easy to Use: Sartobran® P MidiCaps® are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartobran® P 0.45 ?m MidiCaps® are available with various filtration areas from 500 cm? | 0.5 ft? up to 0.45 m? | 5 ft? for easy adoption to any filtration process independent from the batch size. Scalability: Consistent and predictable scale-up and down trials can reliably be performed, as all Sartobran® P filter elements are produced with the same type of membrane and identical materials of construction. Cost Saving: The use of the disposable capsule design concept avoids investments into stainless steel filter housings and eliminates additional costs for cleaning of housings and cleaning validation. Quality Control: Each individual element is tested for integrity by B.-P. and Diffusion-Test prior to being released assuring absolute reliability. Product properties Branch Pharma / Biotech Filter Type Filter Capsules Type Sterile filter Filtration area 1.1 fr? Membrane filter material Cellulose Acetate Technical attributes Support Layers Polypropylene (PP) Structural Compounds Polypropylene (PP) Outer diameter 77 mm Overall length Connector Combinations SS & FF: 0.05 m? | 0.5 ft?: 115 mm; 0.1m? | 1 ft?: 148 mm; 0.2 m? | 2 ft?: 197 mm; 0.45 m? | 5 ft?: 330 mm Min. required Bubble Point 2.0 bar | 29 psi Max. allowed air diffusion at 20 °C and 1.5 bar | 22 psi: 0.05 m? | 0.5 ft? : 3 ml/min; 0.1 m? | 1 ft?: 4 ml/min; 0.2 m? | 2 ft?: 5 ml/min; 0.45 m? | 5 ft?: 10 ml/min Bacterial Endotoxins <0.18 EU/mL as determined by the LAL test Extractables Product meets or exceeds the Quality standards set for "Sterile Water for Injection" by the current USP. Biosafety 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). Sterilization Autoclaving: Min. 25 cycles at max. 134 °C, 2 bar | 29 psi, 30 min. 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. GMP Compliance The product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards. Membrane material Cellulose Acetate (CA) Max. Differential Pressure 20 °C: 72.5 psi; 80 °C: 29 psi Depth filter material Cellulose acetate (CA) Connectors Outlet 1/2'' Hose Barb Connectors Inlet 1/2'' Hose Barb

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