赛多利斯PTFE膜(1盒) 库号:M324686
赛多利斯PTFE膜(1盒) 库号:M324686
赛多利斯PTFE膜(1盒) 库号:M324686
赛多利斯PTFE膜
PTFE>0.2>4PCS/1PACK
货号:5185307T9---SS---A
规格:4个/盒
重量约1.5公斤
Sartoflu ®是适合所有需要无菌空气的应用的解决方案。单层 PTFE 膜结构可确保经过验证的无菌性,同时在各种操作条件下提供大流量。的可以使空气/气体和溶剂过滤的拥有成本低。
Sartofluor® are sterilizing grade air & gas filters that utilize Polytetrafluorethylene (PTFE) membranes. PTFE is a chemically extremely resistant membrane material which is also suitable for highly aggressive solvents. The optimized co
nstruction leads to a perfect hydrodynamic flow. Requirements of Air/Gas Filtration The air filter as a barrier needs to be highly reliable under all circumstances, i.e. pressure pulses, high steaming cycles, elevated moisture co
ntent etc. That’s why we optimized our Sartofluor® air filter cartridges to meet all the requirements with highest assurance levels. Highest hydro
phobicity High flow rates at low differential pressures High steam cycle lifetimes High mechanical and thermal strength Reliable and validated separation of microorganisms and bacteriophage User-Optimized The development of this extremely reliable, secure, “last chance” barrier filter included the experiences of our Research and Development, engineering groups, suppliers, and especially our customers. Their input was and is our most valuable resource to find the optimum performance. Optimum choice for sterile venting and gas applications Sterile gas filtration of fermenter inlets Off-gas filters downstream of fermenters or bioreactors Sterilizing vent filters on autoclaves and Iyophylizers (freeze dryer) Sterile vent filters on product tanks Sterile air supply for service gases, such as filling lines in blow-fill-seal machines Sartofluor® cartridges are available in the optimum range of pore sizes – 0.45 µm, 0.2 µm and 0.1 µm. Dependable performance at every scale Our scale-up philosophy does not stop at liquid filtration. Especially in air filtration, with its variety of applications and demands, different filter sizes are essential. Sartofluor® filter cartridges are available from 300 m² to 2.3 cm² for single filter elements, which means you can effectively filter air from small volume bioreactor to seed and large scale fermenter venting, as well as tank venting. The right hydrophobicity If the filter membrane is not hydrophobic enough, moisture can accumulate and microorganisms may grow. A highly hydrophobic membrane can eliminate this danger along with any risk of water logging. Sartofluor membranes are co
nstructed of PTFE. It provides more than twice the hydrophobicity of polypropylene or PVDF. Optimized co
nstruction adds savings Experience, testing and customer feedback have guided the evolution of Sartofluor cartridges. For example, membrane pleatings and layers of filter fleece have been chosen to avoid water logging. Attention to detail at this level means you realize added savings in low blow down times. Mechanical strength and optimized co
nstruction We‘ve tested Sartofluor cartridges to 134°C and they all withstood 150 steam cycles. No loss in integrity or performance. Or in PTFE hydrophobicity. No loss in flow rate. Plus, optimized Sartofluor cartridge co
nstruction allows differential pressures up to 0.5 bar at 134°C. This exceptio
nal performance has been co
nfirmed by Bacterial Challenge testing. No water blockage. High flow rates. Maximum savings. In air filtration applications, high flow rates result in lower energy costs and help to maximize safety – for example, for tank, venting. Sartofluor® cartridges are optimized to maintain high flow rates, even in challenging process co
nditions like co
ndensate build-up in steam-venting or elevated moisture content. No cartridge does more to co
ntrol life-cycle costs. No cartridge system is more cost-effective. The Reason: Sartofluor® PTFE membrane and support fleece are extremely hydrophobic and feature optimized pleat density. The Result: effective drainage of co
ndensate and no water blockage. Validated performance for assured security Sartofluor® cartridges fulfill all known current regulatory requirements, for example USP, cGMP and FDA. This is docu
mented in our Validation Guidelines for Sartofluor filter cartridges. Besides the validation, Sartofluor® cartridges undergo a stringent performance qualification procedure: They’re pressure-pulsation tested for 5000 cycles at 5 bar differential pressure. They’re steam-cycle e
valuated for 150 cycles at 134°C for 30 min; then 11 additio
nal cycles over 7 hours. Their flow rate and water penetration are measured o
nly after defined steam cycling. They’re tested at maximum allowable differential pressure at a full range of temperatures. Their blow-down time is measured after steam sterilization and Water Intrusion Testing. They pass extractable tests done using RP-HPLC, GC-MS and FTIR. They pass phage challenge tests that last as long as 7 days.
Applications
Industry
Pharma / Biotech
Biological Information
Bacterial Retention
Quantitative Retention of 1 × E7 CFU/cm² Brevundimo
nas Diminuta ATCC® 19146 per ASTM methodology
Compliance Information
Bacterial Endotoxins
< 0.25 EU/mL as determined by the LAL test
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).
Extractables
The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".
Co
nnections (Physical)
Co
nnector Inlet
1.5" Tri-Clamp 50 mm
Co
nnector Outlet
1.5" Tri-Clamp 50 mm
Dimensions
Filter Size
size 9 (0.2 m² / 2.2 ft²)
Filtration Area
0.2 m²
General Specifications
Capsule/Cartridge Format
Midicaps®
Maximum Diffusion
4 mL/min at 0.7 bar
Minimum Required Bubble Point
1.0 bar | 14.5 psi
Materials of Construction
Housing Material
Polypropylene (PP)
Material o-ring | seal
Silicone (SI)
Support Fleece
Polypropylene (PP)
Operating Conditions
Maximum Differential Pressure
20 °C: 5 bar; 50 °C: 3 bar
Physicochemical Information
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.
Pore Size Final-filter
0.2 µm
Product Information
Brand
Sartofluor®
Sterility
Sterilization Method
Autoclavable
Usage Protocols
Sterilization Procedures
Autoclaving: Min. 25 cycles at max. 134 °C, 2 bar | 29 psi, 30 min.

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