Sartorius Sartobran® P 0.45 + 0.2 mic filter MidiCaps® 5235307H0--SS--V 2/Pack, US $99.00 – Picture 0

Sartorius Sartobran® P 0.45 + 0.2 mic filter MidiCaps® 5235307H0--SS--V 2/Pack, US $99.00 – Picture 1

Sartorius Sartobran® P 0.45 + 0.2 Mic Filter Midicaps® 5235307h0--ss--v 2/pack

US $99.00

Oceanside, California, United States
Jan 30th

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Description Sartobran® P membrane filter MidiCaps® are self-contained, ready-to-use, sterile filter units for sterilizing grade filtration in the pharma| biotech industry. The extremely low, unspecific adsorption of their cellulose acetate membranes assures highest protein yields and rapid preservative recovery. Applications: Sartobran® P filter elements have proven throughout the years to be the first choice for all applications in the biopharmaceutical industry requiring low adsorption capabilities. They are typically used for sterilizing grade filtration of: – Coagulation Factors, Albumin, IgG – Bacterial & 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 0.2 µm MidiCaps® are available with various filtration areas from 500cm? | 0.5 ft? up to 0.5m? | 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 MidiCaps® 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. Microbiological Retention: Sartobran® P MidiCaps® 0.2 µm rated 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 being released, assuring absolute reliability. Documentation: Sartobran® P MidiCaps® are designed, developed and manufactured in accordance with the ISO 9001 Certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Applications: Sartobran P filters are ideally suited for all applications that require highest product recovery rates like: Coagulation Factors, Albumine, IgG, Bacterial and Viral Vaccines, MAB's, Bio-processed Pharmaceuticals, Diagnostics, Purified Protein Solutions, Biological Fluids, Solutions 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 0.2 µm filters are available in traditional cartridge formats and disposable capsules from 150 cm? to 1.8 m? for simple linear scale-up and process flexibility. Scalability: Consistent and predictable scale-up and down trials can reliably be performed as all Sartobran® P MidiCaps® 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. Microbiological Retention: Sartobran® P 0.2 µm rated MidiCaps® are fully validated as sterilizing grade filter elements according to HIMA and ASTM F-838-05 guidelines. Quality Control: Each individual element is integrity tested by diffusion and bubble point test prior to release, assuring absolute reliability. Product properties Branch Pharma / Biotech Filter Type Filter Capsules Type Sterile filter Filtration area 4.8 ft? 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 3.2 bar | 46 psi Max. allowed air diffusion at 20 °C and 2.5 bar | 36 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?| 4.5 ft?: 10 ml/min Bacterial Retention Quantitative Retention of 1 x E7 CFU/cm? Brevundimonas Diminuta ATCC 19146 per ASTM methodology 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, 30 min Non-Fiber Releasing This product complies with title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72 GMP Compliance This 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 Connectors Inlet Tri-Clamp 50 mm (1 1/2'') Connectors Outlet Tri-Clamp 50 mm (1 1/2'')