Quality Level
material
316 stainless steel cannula, PureFlex™ polyethylene bag (Drainage bag), polycarbonate syringe (fluid contact layer), polyester body, silicone septum (platinum-cured), silicone syringe (medical fluid contact layer; platinum cured silicone), silicone tubing
agency
ISO 10993-5 (all component materials), USP 87 Cytotoxicity Elution Test (In Vitro), according to ISO 11137 (sterilization), according to ISO 146441, meets the criteria for Biological Reactivity Testing: can be any one or a combination of the following test methods USP<88> Systemic Injection Test (In Vivo)
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-20-50 °C temp. range (-4-122 °F), 0.50 bar max. pressure (7.25 psi)
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
fitting
female Luer-Lok® outlet, male Luer-Lok® outlet
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pathogen testing
pharma/biopharma processes
pyrogen testing
sterile sampling
sterility testing
viral therapy
storage temp.
10-30°C
General description
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. The ability to accurately measure the sample taken is particularly important for sampling of high value products and reduces expensive product waste. The syringes are ideal for storage. 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.
Application
Packaging
Preparation Note
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Other Notes
Body: Polyester
Cannula: ASTM® 316 L Stainless steel
Drainage bag: Polyethylene film (PureFlex™ film)
Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
Tubing: Silicone
Outlet Tubing: Female and male Luer-Lok®
Legal Information
法规信息
此项目有
商品
Explore microbial control strategies in drug manufacturing: bioburden management, contamination prevention, and reliable closed sampling.
Explore the importance of closed sampling in pharma manufacturing, focusing on regulatory guidance, bioburden control, and process monitoring.
Symbolic depiction of a (bio-)pharmaceutical process with persons in lab coats working, possibly taking samples.
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| E464-90020 | 04061841097860 |