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物料
316 stainless steel cannula
polyester body
polyethylene bottle (fluid contact layer)
silicone septum (platinum-cured )
silicone tubing
质量水平
Agency
according to ISO 11137 (sterilization)
certified by the 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) at ±25 °C
杂质
<2.15 EU/device bacterial endotoxins (LAL test)
配件
male Luer-Lok® outlet (with female sterile vent filter)
应用
bioburden testing
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pharma/biopharma processes
sterile sampling
viral therapy
储存温度
room temp
相关类别
一般描述
Device configuration: Single Unit Sampling - Pre-loaded system
The NovaSeptum® GO pre-loaded disposable magazine is available with various standard configurations using NovaSeptum® GO high purity bags, autoclavable bags, bottles, transfer tubes or accurate volume (AV) syringe units. Other configurations are available upon request. For an optimal aseptic solution, use the NovaSeptum® GO pre-loaded disposable magazine together with a 1.5" or 2" NovAseptic® connector and NovaSeptum® GO pre-loaded starter kit (5/9 shot stainless steel base). 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
E9SU221-00215 (9x50 ml bags, 3 units per box)
E9SU221-00216 (9x100 ml bags, 3 units per box)
E9SU221-C0243 (9x250 ml bags, 3 units per box)
E9SU221-C0244 (9x1000 ml bags, 3 units per box)
E9SU221-00216 (9x100 ml bags, 3 units per box)
E9SU221-C0243 (9x250 ml bags, 3 units per box)
E9SU221-C0244 (9x1000 ml bags, 3 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.
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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