TZHASV210

Steritest^® NEO Device

suitable for sterility testing, with small diameter double needle adapter for liquids in small vials with septa, pkg of 10 blisters per box, Single packed

• eCl@ss: 32014001
• NACRES: NB.24

Properties

• Quality Level: 400
• 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)
• 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 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, 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 is provided with a small diameter double needle adapter for small vials with septa. The blue canisters indicate mixed cellulose ester (MCE) membrane, which provides an optimal filtration flow rate for standard products.

Application

The Steritest^® NEO Device is used for sterility testing of small volume parenterals and synthetic drugs without antimicrobial activity.

Legal Information

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

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

Safety Information

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