DEM711-10100

Trial kit - NovaSeptum^® GO; High Purity Bag Sampling System, 100ml

• UNSPSC Code: 60104202

Propiedades

• material: PureFlex^™ polyethylene bag (Fluid contact layer, film); TPE tubing (Thermoplastic elastomer); polyester body; silicone septum (platinum-cured); stainless steel body (ASTM^® 316 L)
• Quality Level: 400
• agency: according to ISO ISO 11137; meets USP 88 Biological Reactivity
• sterility: sterile; β-irradiated
• product line: NovaSeptum^® GO
• feature: autoclavable: no
• parameter: -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) (for 1000 mL); 0.50 bar max. pressure (7.25 psi) (up to 250 mL)
• impurities: <2.15 bacterial endotoxins (LAL test, EU/device)
• fitting: female Luer-Lok^® outlet (3-piece); 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

Descripción

General description

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.

Application

Sterile sampling

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

Packaging

5x High Purity 100ml bag

Components

• 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

Preparation Note

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.

Legal Information

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