材料
316 stainless steel cannula (ASTM®)
PureFlex™ polyethylene bag
TPE tubing
polyester body (platinum-cured)
silicone septum (platinum-cured)
品質等級
agency
according to ISO 11137 (sterilization)
according to ISO 146441
meets USP 88 Biological Reactivity (all component materials)
無菌
sterile; β-irradiated
產品線
NovaSeptum® GO
特點
autoclavable: no
參數
-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)
雜質
<2.15 EU/device bacterial endotoxins (LAL test)
接頭
female Luer-Lok® outlet (3-piece with injection site)
male Luer-Lok® outlet (3-piece )
應用
cell therapy
gene therapy
life science and biopharma
mAb
ophthalmics
parenterals
pharma/biopharma processes
sterile sampling
viral therapy
儲存溫度
room temp
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一般說明
應用
包裝
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)
成分
- 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
準備報告
Aqueous extraction contains < 2.15 EU per device as determined using the Limulus Amebocyte Lysate (LAL) test.
法律資訊
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