DEM714-10100

Trial kit - NovaSeptum^® GO; High Purity Bag Sampling System, 100ml, Manifold (5-valve)

• 分類程式碼代碼: 60104202

属性

• 材料: PureFlex^™ polyethylene bag (film); TPE tubing (Thermoplastic elastomer); polyester body; silicone septum (platinum-cured); stainless steel body (ASTM^® 316 L)
• 品質等級: 400
• agency: according to ISO ISO 11137; meets USP 88 Biological Reactivity
• 無菌: sterile; β-irradiated
• 產品線: NovaSeptum^® GO
• 特點: autoclavable: no
• 參數: -20-50 °C temp. range (-4-122 °F) (1000 mL); -80-50 °C temp. range (-112-122 °F) (50 mL to 250 mL (when used with a NovaSeptum^® Case)); 0.30 bar max. pressure (4.35 psi)
• 雜質: <2.15 bacterial endotoxins (LAL test, EU/device)
• 接頭: female Luer-Lok^® outlet (3-piece); 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

说明

一般說明

A range of NovaSeptum^® GO small pack size kits available to trial a sterile sampling solution for your process. Choose from several collection container types: high purity bags, autoclavable bags, bottles or accurate volume syringes (5 containers per pack). The 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. 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. Autoclavable bags are intended for applications where the unit is connected to a vessel that needs to be sterilized by autoclave. Bio-neutral plastic bottles or high purity bags are ideal for all tests and are available in a range of sizes. Use a trial kit in combination with a NovaSeptum^® GO holder.

應用

Sterile sampling

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

包裝

Manifold, 5x 100ml bags

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

All component materials, in contact with sampling liquid, meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo.
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.

Assembled under ISO Clean Room Class 8 conditions in a facility certified to ISO 14644-1 standards.

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany