TZHVSL210

Steritest^® NEO Device

This green base canister with a single needle is ideal for testing solvents, creams, ointments, and veterinary injectables.

• Synonym(s): Green 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 (for canister); Nylon 66 adapter (for needle); PVC tubing (double lumen); PVDF membrane; plain filter; stainless steel (for needle)
• 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: green Canister Base
• matrix: Durapore^®
• pore size: 0.45 μm pore size
• input: solvent(s); sample type pharmaceutical(s)
• application(s): pharmaceutical; sterility testing
• 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 minimizes false positives and offers the highest levels of quality and reliability, ensuring that pharmaceutical products are never exposed to the environment during the testing process. 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 canister connections and reinforced base structure provide better resistance to pressure. The single needle adapter is used for products in vials or ampoules. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The canisters come with green canister base indicating increased chemical compatibility with solvents due to Durapore^® Poly vinylidene fluoride (PVDF) membrane and specific canister polymer (nylon). This optimizes the chemical compatibility of products dissolved in solvents.

Application

The Steritest^® NEO Device is used for sterility testing of products dissolved in solvents (such as creams, ointments and veterinary injectables), requiring increased chemical compatibility.

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 from all 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

Durapore 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