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物料
316 stainless steel cannula
polyester body
polypropylene bag
silicone septum (platinum-cured)
silicone tubing
质量水平
Agency
according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)
无菌性
sterile; β-irradiated
产品线
NovaSeptum® GO
特点
autoclavable
参数
-20-125 °C temp. range (-4-257 °F)
0.30 bar max. pressure (4.35 psi)
杂质
<2.15 EU/device bacterial endotoxins (LAL test)
配件
male Luer-Lok® outlet (with female sterile vent filter)
应用
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
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一般描述
Device configuration: single unit sampling
The NovaSeptum® GO autoclavable vented sampling unit is intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Available in 50 ml, 100 ml, 250 ml and 1000ml sizes. A closed, sterile sampling method can significantly reduce risk of cross contamination. Ideal for sampling from aseptic and sterile processes, the NovaSeptum® GO sterile sampling system provides consistently representative samples, safely and securely.
应用
Mobile Tanks
Autoclaved
Autoclaved
包装
E221-00215 (50 ml bags, 40 units per box)
E221-00216 (100 ml bags, 40 units per box)
E221-C0243 (250 ml bags, 40 units per box)
E221-C0244 (1000 ml bags, 40 units per box)
E221-00216 (100 ml bags, 40 units per box)
E221-C0243 (250 ml bags, 40 units per box)
E221-C0244 (1000 ml bags, 40 units per box)
组分
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Fluid contact layer (bag): Polypropylene film
- Tubing: Silicone
- Outlet Tubing: Male Luer-Lok® with female sterile vent filter
制备说明
Units are integrity tested at regular intervals during manufacturing.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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