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物料
TPE tubing (Thermoplastic elastomer)
polyester body
polyethylene bottle (Fluid contact layer, Terephtalate Glycol)
silicone septum (platinum-cured)
stainless steel body (ASTM® 316 L)
质量水平
Agency
according to ISO ISO 11137
meets USP 88 Biological Reactivity
无菌性
sterile; β-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 bacterial endotoxins (LAL test, EU/device)
配件
outlet (cap)
应用
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
储存温度
room temp
相关类别
一般描述
A range of NovaSeptum® GO small pack size kits available to trial a sterile sampling solution for your process. Choose from several collection container types: high purity bags, autoclavable bags, bottles or accurate volume syringes (5 containers per pack). The 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. NovaSeptum® GO Accurate Volume Syringes are designed to take samples from 1 mL to 20 mL, enabling operators to directly dispense sample products with milliliter accuracy. Autoclavable bags are intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Bio-neutral plastic bottles or high purity bags are ideal for all tests and are available in a range of sizes. Use a trial kit in combination with a NovaSeptum® GO holder.
应用
Sterile sampling
Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications
包装
5x Bottle 60ml
组分
- 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
制备说明
All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
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.
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.
Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.
法律信息
ASTM is a registered trademark of American Society for Testing and Materials
NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany
法规信息
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