Devices Constructed of the Same Materials
as Larger-Capacity Capsules and Cartridges
- 简化了规模扩大并最大限度地减少重新验证；在向中试或生产过渡的过程中无需更改膜材料。
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Four membrane chemistries assure compatibility with a wide range of fluids:
- Supor® membrane has high flow rates and throughputs, and is ideal for solutions where low protein binding is required.Not recommended with some ketones.
- Fluorodyne® II membrane offers high flow rates and is ideal for applications where PVDF membrane is specified.Not recommended with some ethers.
- Ultipor® membrane provides broad solvent and chemical compatibility, and low extractables.
- Posidyne® membrane enhances bioburden and pyrogen removal from aqueous solutions.
- Integrity testable (water bubble point).
- Bacterial retention tested.
- Sterilized by gamma irradiation to eliminate potential contamination by EtO residuals.
- Drug development studies
- Determination of product compatibility and recovery
- Preliminary filterability testing
- Small-volume liquid sterilization
材料成分
- Filter Media：Supor [hydrophilic polyethersulfone (PES)], Fluorodyne II (hydrophilic PVDF), Ultipor (Nylon 6,6), and Posidyne (positively-charged Nylon 6,6) membranes
- Housing:聚丙烯
有效过滤面积
- 2.8 厘米2
Inlet/Outlet Connections
- Female luer lock inlet, male slip luer outlet
一般滞留量
- < 100 μL
Maximum Operating Temperature
- 60 °C (140 °F) at 2.1 bar (210 kPa, 30 psi)
最大操作压力
- 5.4 bar (540 kPa, 80 psi) at ambient temperature
Typical Water Flow Rate
- mL/min at 2.1 bar (210 kPa, 30 psi)
- PN 4905:130
- PN 4906:78
- PN 4907:130
- PN 4908:77
Recommended Integrity Test Minimum Bubble Point - Water
- PN 4905:3.5 bar (350 kPa, 51 psi)
- PN 4906, 4908, and 4907:3.2 bar (320 kPa, 46 psi)
- PN 4902:3.32 bar (332 kPa, 48 psi)
Bacterial Retention
- Lot samples retain a minimum of 107 cfu/cm2 of B. diminuta per modified ASTM F838-05, current revision
Endotoxin Level
- < 0.25 EU/mL using Limulus Amoebocyte Lysate (LAL) test
Biological Safety
- Passes United States Pharmacopeia (USP) Biological Reactivity Test, In Vivo <88>
Sterilization
- Sterilized by gamma irradiation and individually packaged
