TZHAMD210

Steritest^® NEO Device

For medical devices and collapsible bags. Blue base canister provided with 3 adaptors for connecting various test devices.

• Synonym(s): Blue Base Steritest^® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration
• UNSPSC Code: 23151818
• eCl@ss: 32014001
• NACRES: NB.24

Properties

• material: Nylon 66 adapter (for needle); PVC tubing (double lumen); mixed cellulose esters (MCE) membrane; plain filter; stainless steel ( for needle); styrene-acrylonitrile (SAN) ( for Canister)
• Quality Level: 400
• agency: EP 2.6.1; JP 4.06; USP 71
• sterility: sterile; γ-irradiated
• manufacturer/tradename: Steritest^®
• packaging: pkg of 10 blisters per box, Single packed
• parameter: 120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL); 3.1 bar max. inlet pressure (45 psi) at 25 °C; 45 °C max. temp.
• tubing L: 850 mm
• color: blue Canister Base
• matrix: MF-Millipore^™
• pore size: 0.45 μm pore size
• input: sample type pharmaceutical(s)
• application(s): pharmaceutical; sterility testing
• compatibility: for use with Steritest^® Symbio FLEX Pump Kit, 2 media (SYMBFLE01); for use with Steritest^® Symbio ISL Pump Kit, 2 media (SYMBISL01); for use with Steritest^® Symbio LFH Pump Kit (SYMBLFH01)
• shipped in: ambient

Description

General description

Device Configuration: 2 canisters

Steritest^® NEO Device is a membrane filtration device for sterility testing of filterable pharmaceutical products. The device simplifies every aspect of testing, from handling to traceability. The closed system ensures that pharmaceutical products are never exposed to the environment during the testing process. This minimizes false positives and offers the highest levels of quality and reliability. This test system offers an optimized and fully regulatory compliant testing process, when used with the Steritest^® Symbio pump, specific accessories and high-quality culture media and rinsing fluids. The Steritest^® NEO Device for medical devices provides three adapters: male Luer, female Luer or single needle allow connection to a variety of test devices. A separate vent needle is used for the transfer of culture media or rinse buffer. The Steritest^® NEO Device for medical devices can be used with Novaseptum^® for sterile sampling devices. The blue canister base indicates mixed cellulose esters (MCE) membrane. This membrane provides an optimal filtration flow rate for standard products.

Application

Steritest^® NEO Device for medical device and collapsible bags is used for sterility testing of medical devices, collapsible bags and products without antimicrobial agents.

Features and Benefits

• One-stop-shop for sterility testing with our devices, pumps, media, fluids, and services
• Steritest^® devices are manufactured in our Center of Excellence in Molsheim, France, with high-quality control standards maintaining the Certificate of Quality for each lot.
• New needle design

The design of this new needle has been optimized with short needle length, grips, and ridges to offer dexterity and security to the operator while piercing the small container

• Smarter workflow

The new Steritest^® NEO cartridge device benefits fromall the improvements such as colored clamps, graduations for accurate volume measurement, optimized identification, and traceability with the new peel-off label

• Completely closed set up

Pharmaceutical products are never exposed to the environment during the testing process with Steritest^® NEO devices. Filtration, rinsing, media addition and incubation are conducted within a closed system.

• Consistent performance

100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest^® NEO device before release from manufacturing.

• New tubing disconnection tool

The Velax^® cutting clamps are mounted on all Steritest^® NEO devices and allow safe and easy cutting of the tubes.

Packaging

Pack of 10 single packed blisters per box

Legal Information

MF-Millipore is a trademark of Merck KGaA, Darmstadt, Germany

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

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

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

Safety Information

• Storage Class: 11 - Combustible Solids
• wgk_germany: WGK 2