TZHASY210

Steritest^® NEO Device

For liquids in syringes. Blue base canister with vented double needle adapter for sequential testing of syringe contents and needle surfaces.

• 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; 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); liquid
• 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. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. The closed system 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 device comes with vented double needle. The adapter allows for sequential testing of syringe contents and needle surfaces. The system has two blue based canisters with mixed cellulose esters (MCE) membrane, providing an optimal filtration flow rate for standard products.

Application

The Steritest^® NEO Device for liquids in syringes is used for sterility testing of pre-filled syringes, for 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

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