E461

NovaSeptum^® GO Accurate Volume Syringe Sampling System

sterile; β-irradiated

• 同義詞: NovaSeptum^® GO Accurate Volume Syringes
• 分類程式碼代碼: 41104105

屬性

• 材料: 316 stainless steel cannula; polycarbonate syringe (fluid contact layer); polyester body; silicone septum (platinum-cured); silicone syringe (medical fluid contact layer; platinum cured silicone); silicone tubing
• 品質等級: 400
• 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
• 參數: -80-121 °C temp. range (-112-250 °F) (20ml); -80-134 °C temp. range (-112-273 °F) (5ml); 0.50 bar max. pressure (7.25 psi)
• 雜質: <2.15 EU/device bacterial endotoxins (LAL test)
• 接頭: female Luer-Lok^® outlet; male Luer-Lok^® outlet
• 應用: cell therapy; gene therapy; life science and biopharma; mAb; ophthalmics; parenterals; pathogen testing; pathogen testing; pharma/biopharma processes; pyrogen testing; sterile sampling; sterility testing; viral therapy
• 儲存溫度: room temp

描述

一般說明

Device configuration: single unit sampling

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. For sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis and fermentation applications. 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.

應用

Sterility testing, pyrogenic testing, endotoxin testing, chemical analysis, pH analysis, and fermentation applications

包裝

E461-90005 (5 ml syringes, 50 units per box)
E461-90020 (20 ml syringes, 40 units per box)

成分

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (syringe): Polycarbonate, platinum-cured silicone, medical silicone fluid
• Tubing: Silicone
• Outlet Tubing: Female and male Luer-Lok^®

準備報告

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.

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials

Luer-Lok is a registered trademark of Becton-Dickinson & Co.

NOVASEPTUM is a registered trademark of Merck KGaA, Darmstadt, Germany