2pc Sartorius Stedim Sartopore 2 sterile midicap 0.8+0.45um filter capsules 5445306G7--OO--A Condition: Brand New. Actual item pictured. Filtrationarea: 0,05 - 0,45 m² Ready-to-use disposable filter capsules for bioburden & defined particle reduction of biological solutions. They are used for prefiltration of aqueous solutions and highly viscous & difficult to filter pharmaceutical products in pilot & small scale biotech manufacturing. Disposable MidiCaps® for Process Scale Reduction of Cleaning & Cleaning Validation Proven Performance of Sartopore® 2 Description Sartopore® 2 0.45 ?m membrane filter MidiCaps are self contained, ready to use filter units for bioburden reduction and particle removal from a broad range of pharmaceutical products. Membrane prefiltration of aqueous solutions and highly viscous pharmaceutical products difficult to filter can effectively be accomplished due to the outstanding total throughput and flow rate performance of Sartopore® 2 0.45 ?mMidiCaps. Applications: Typical applications include bioburden reduction and particle removal from: – Therapeutics – Injectables – Buffers – Biological Fluids – Tissue Culture Media – Acetic and basic solutions. Compatibility: The polyethersulfone membrane is compatible with a pH-range from pH 1 to pH 14 making Sartopore® 2 MidiCaps ideal for filtration of solutions with high |low pH. Easy to use: Sartopore® 2 MidiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartopore® 2 0.45 ?m MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 4.5 ft² and various connector styles 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 Sartopore® 2 filter elements are produced with the same type of membrane and materials and identical construction. Cost Saving: The use of the disposalbe capsule design concept avoids investments into stainless steel filter housings and eliminates additionalcosts for cleaning of housings and cleaning validation. Microbiological Retention: Sartopore® 2 filter MidiCaps 0.45 ?m rated are fully validated with a Log Reduction Value (LRV) of 7 for Serratia Marcescens according to HIMA and ASTM F-838 05 procedures. 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 MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Applications: Typical applications include bioburden reduction and particle removal from: Therapeutics Injectables Buffers Biological Fluids Tissue Culture Media Acidic and basic solutions Compatibility: The polyethersulfone membrane is compatible with a pH range from pH 1 to pH 14 making Sartopore® 2 MidiCaps ideal for filtration of solutions with high | low pH. Easy to Use: Sartopore® 2 MidiCaps are delivered as individually packed sterile units. On site, pre-use sterilization can be eliminated. Flexibility: Sartopore® 2 0.45 ?m MidiCaps are available with various filtration areas from 500 cm² | 0.5 ft² up to 0.45 m² | 5 ft² and various connector styles 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. Microbiological Retention: Sartopore® 2 MidiCaps 0.45 ?m rated are fully validated with a Log Reduction Value (LRV) of 7 for Serratia Marcescens according to HIMA and ASTM F-838 05 procedures. 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 MidiCaps are designed, developed and manufactured in accordance with a ISO 9001 certified Quality Management System. A Validation Guide is available for compliance with regulatory requirements. Product properties Branch Pharma / Biotech Filter type Filter Capsules Type Sterile filter Filtration area 0,05 m² Membrane filter material Polyethersulfone (PES) Technical attributes Support Layers Polypropylene (PP) Structural Compounds Polypropylene (PP) Outer diameter 77 mm Overall length Connector Combinations SS & FF: 0.05 m² | 0.5 ft²: 115 mm; 0.1m² | 1 ft²: 148 mm; 0.2 m² | 2 ft²: 197 mm; 0.45 m² | 5 ft²: 330 mm Min. required Bubble Point 2.2 bar | 32 psi Max. allowed air diffusion at 20 °C: 0.05 m² | 0.5 ft²: 3 ml/min at 1.7 bar | 25 psi; 0.1 m² | 1 ft²: 4 ml/min at 1.7 bar | 25 psi; 0.2 m² | 2 ft²: 6 ml/min at 1.7 bar | 25 psi; 0.45 m² | 5 ft²: 12 ml/min at 1.7 bar | 25 psi 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). Sterilisation Autoclaving: Min. 25 cycles at max. 134 °C, 2 bar | 29 psi, 30 min. Non-Fiber Releasing This product complies with the 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 Polyethersulfone (PES) Max. Differential Pressure 20 °C: 5 bar; 80 °C: 2 bar Depth filter material Polyethersulfone (PES) Connectors Inlet 1/2'' Hose Barb Connectors Outlet 1/2'' Hose Barb Notice: Before purchase, please be sure to check correct item type/model needed. Terms & Conditions PAYMENT: Full payment is due within 3 days. Preferred payment method is PayPal. We do accept card payment at 916-225-3615. We may process your payment as per your organizations policy if needed, for specific payment needs or company invoice please email or call us at 916-225-3615. International Buyers: We do ship all items worldwide, email us if you need a shipping quote or have any questions. We can ship via USPS, UPS or FedEx, if you prefer for us to use your ups/FedEx account number please provide your account # upon purchase. Make sure your shipping address is correct and a phone number included. Customs and duty fees and/or taxes are the buyer's responsibility. SHIPPING: We will ship your item(s) within 1-2 business days after receipt of a cleared payment. We may combine shipping if the items fit in the same package. If you wish to use your shipping service or shipping account# please let us know upon purchase. Notify us if you have any special shipping/handling requests. We ship with USPS UPS and FedEx. RETURN POLICY: We offer a 30-day return on all products, if item arrives damaged or not as described or due to any error on our part, we will refund the full amount with ship charges both ways. If buyer decides to return an item for any other reason, in this case the buyer pays return shipping. FEEDBACK: NO NEED FOR NEGATIVE OR NEUTRAL FEEDBACK. If there is a problem please contact us before leaving feedback. If an item arrived not as described or you are not satisfied with the item or shipping time, we will resolve all issues. We strive for a 5-star detailed seller rating and work hard for our customer’s satisfaction by providing a smooth transaction. CONTACT US: If you have any questions, please feel free to contact us through eBay messaging by clicking "ask a question" on bottom left of this page. You may also call us direct for questions/requests or payment at 916-225-3615. Also, our direct email can be found by clicking on our store name or the "me" button.
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