物料
316 stainless steel cannula
PETG bottle (fluid contact layer)
TPE tubing
polyester body
silicone septum (platinum-cured)
质量水平
Agency
according to ISO 11137 (sterilization)
meets ISO 146441
146441
meets ISO 88 biological reactivity (all component materials)
无菌性
sterile; γ-irradiated
产品线
NovaSeptum® GO
特点
autoclavable: no
参数
-80-50 °C temp. range (-112-122 °F)
0.50 bar max. pressure (7.25 psi)
杂质
<2.15 EU/device bacterial endotoxins (LAL test)
应用
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
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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
Endotoxin
Bioburden - Archiving
Bioburden - Archiving
包装
E9SU871-80060 (9x60 ml bottles, 3 units per box)
E9SU871-80125 (9x125 ml bottles, 2 units per box)
E9SU871-80250 (9x250 ml bottles, 1 units per box)
E9SU871-80125 (9x125 ml bottles, 2 units per box)
E9SU871-80250 (9x250 ml bottles, 1 units per box)
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.
其他说明
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Fluid contact layer (bottle): Polyethylene Terephtalate Glycol
- Tubing: Thermoplastic elastomer (TPE)
- Outlet Tubing: Cap
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
NOVASEPTIC is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
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