NovaSeptum^® GO Sampling Unit; High Purity Application

material

316 stainless steel cannula (ASTM^®), PureFlex^™ polyethylene bag, TPE tubing (Thermoplastic elastomer), polyester body, silicone septum (platinum-cured)

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) (up to -80°C/-112°F when used with a NovaSeptum^® Case), 0.30 bar max. pressure (4.35 psi)

impurities

<2.15 EU/device bacterial endotoxins (LAL test)

fitting

female Luer-Lok^® outlet (3-piece), male Luer-Lok^® outlet (3-piece containing an injection site), male Luer-Lok^® outlet (3-piece)

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.

room temp

Quality Level

400