产品名称
Optiseal 0.2 µm 4′ 滤芯, Chemistry: Hydrophobic Polytetrafluoroethylene (PTFE) Configuration: 4 in.
material
PTFE
Quality Level
sterility
non-sterile
sterilization compatibility
steam-in-place compatible
product line
OptiSeal® 4 in.
feature
hydrophobic
technique(s)
gas filtration: suitable
cartridge nominal length
4 in.
impurities
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables
≤10 mg/cartridge
matrix
Aervent®
pore size
0.2 μm pore size
cartridge code
not applicable
General description
设备配置：纯化柱
Preparation Note
本产品采用符合21 CFR 210.3(b)（6）中规定的“无纤维释放”过滤器标准的PTFE膜生产。
Analysis Note
可提取物质量：受控室温下，在70/30% 异丙醇/水混合液中浸泡24小时后测定。
细菌截留
按ASTM® F838方法进行细菌挑战，样品可截留1 x 10⁷ CFU/cm²以上浓度的缺陷短波单孢菌。
按ASTM® F838方法进行细菌挑战，样品可截留1 x 10⁷ CFU/cm²以上浓度的缺陷短波单孢菌。
Other Notes
这些产品在符合FDA药品生产质量管理规范的工厂生产。
Legal Information
AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
OPTISEAL is a registered trademark of Merck KGaA, Darmstadt, Germany
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| LAGR04TP1 | 04053252819896 |