E871

NovaSeptum^® GO Bottle Sampling System

sterile; γ-irradiated

• Synonym(s): NovaSeptum^® GO Bottle
• UNSPSC Code: 41104105

Properties

• material: 316 stainless steel cannula (ASTM^®); PETG bottle; PureFlex^™ polyethylene bottle; TPE tubing (Thermoplastic elastomer); polyester body; silicone septum (platinum-cured)
• Quality Level: 400
• Agency: according to ISO 11137 (sterilization); according to ISO 146441; meets USP 88 biological reactivity (all component materials)
• sterility: sterile; γ-irradiated
• product line: NovaSeptum^® GO
• feature: autoclavable: no
• parameter: -80-50 °C temp. range (-112-122 °F); 0.50 bar max. pressure (7.25 psi)
• impurities: <2.15 EU/device bacterial endotoxins (LAL test)
• fitting: outlet (Cap)
• application(s): bioburden testing; cell therapy; gene therapy; life science and biopharma; mAb; ophthalmics; parenterals; pathogen testing; pharma/biopharma processes; sterile sampling; viral therapy
• storage temp.: room temp

Description

General description

Device configuration: single Unit Sampling

The NovaSeptum^® GO bottle sampling unit is intended for applications where high purity, such as low endotoxin levels, is required. This sampling unit is available with a 2 mm needle and must be used with a NovaSeptum^® GO holder. The bio-neutral plastic bottles are ideal for all tests and available in a range of sizes. 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.

Application

Endotoxin
Bioburden -
Archiving

Packaging

E871-80060 (60 ml bottle, 40 units per box)
E871-80125 (125 ml bottle, 25 units per box)
E871-80250 (250 ml bottle, 20 units per box)
E871-80500 (500 ml bottle, 12 units per box)

Components

• Septum: Platinum-cured silicone
• Body: Polyester
• Cannula: ASTM^® 316 L Stainless steel
• Fluid contact layer (bottle): Polyethylene Terephtalate Glycol(PETG)
• Tubing: Thermoplastic elastomer (TPE)
• Outlet Tubing: Cap

Preparation Note

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.

Legal Information

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

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

PUREFLEX is a trademark of Merck KGaA, Darmstadt, Germany