Select a Size
About This Item
Quality Segment
material
316 stainless steel cannula (ASTM®), PureFlex™ polyethylene bag, TPE tubing, polyester body (platinum-cured), silicone septum (platinum-cured)
agency
according to ISO 11137 (sterilization), according to ISO 146441, meets USP 88 Biological Reactivity (all component materials)
sterility
sterile; β-irradiated
product line
NovaSeptum® GO
feature
autoclavable: no
parameter
-80-50 °C temp. range (-112-122 °F), 0.50 bar max. pressure (7.25 psi) (for 1000 mL), 0.50 bar max. pressure (7.25 psi) (up to 250 mL)
impurities
<2.15 EU/device bacterial endotoxins (LAL test)
fitting
female Luer-Lok® outlet (3-piece with injection site), male Luer-Lok® outlet (3-piece )
application(s)
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
storage temp.
room temp
General description
Application
Packaging
E5SU711-10100 (5x100 ml bags, 8 units per box)
E5SU711-10250 (5x250 ml bags, 7 units per box)
E5SU711-11000 (5x1000 ml bags, 6 units per box)
Preparation Note
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
Other Notes
- Septum: Platinum-cured silicone
- Body: Polyester
- Cannula: ASTM® 316 L Stainless steel
- Fluid contact layer (bag): Polyethylene film (PureFlex film)
- Tubing: Thermoplastic elastomer (TPE)
- Outlet Tubing: 3-piece Luer-Lok®, containing a male, female and an injection site
Legal Information
Regulatory Information
This item has
Stay compliant with GMP using the Emprove® Program
Accelerate qualification, maintain compliance, and save time with Emprove® Dossiers.
Note: you will be brought to EmproveSuite.com. Your username and password are separate from SigmaAldrich.com and may differ.
Register for free and access Emprove® Dossiers within minutes. Upgrade your subscription plan to unlock advanced and customized content in the Emprove® Suite
Not finding what you are looking for? Visit the Emprove® Program Help page.
Already Own This Product?
Find documentation for the products that you have recently purchased in the Document Library.
Articles
Explore the importance of closed sampling in pharma manufacturing, focusing on regulatory guidance, bioburden control, and process monitoring.
Struggling to find a sampling solution for your process? Explore sterile manual and automated aseptic sampling to ensure product quality and safety.
Explore microbial control strategies in drug manufacturing: bioburden management, contamination prevention, and reliable closed sampling.
Global Trade Item Number
| SKU | GTIN |
|---|---|
| E5SU711-11000 | 04061841098027 |
| E5SU711-10050 | 04061841097990 |
| E5SU711-10250 | 04061841098010 |
| E5SU711-10100 | 04061841098003 |