TZHVSL210

Steritest^® NEO Device

suitable for sterility testing, with single needle adaptor for products in vials or ampoules, pkg of 10 blisters per box, Single packed

• eCl@ss: 32014001
• NACRES: NB.24

Properties

• Quality Level: 400
• material: Nylon (for canister); Nylon 66 adapter (for needle); PVC tubing (double lumen); PVDF membrane; plain filter; stainless steel (for needle)
• 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: sample type pharmaceutical(s); solvent(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.

Legal Information

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

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