TZHALV205

Steritest^® NEO Device

For liquids in large vials., Blue base canister with a vented double needle for large glass containers with septa., pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed

• 別名: Blue Base Steritest^® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration
• UNSPSCコード: 23151818
• eCl@ss: 32014001
• NACRES: NB.24

特性

• 物質: 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)
• 品質水準: 400
• 認証: EP (2.6.1); JP (4.06); USP 71
• 無菌性: sterile; γ-irradiated
• 特徴: Blue base canister with a vented double needle for large glass containers with septa.
• メーカー／製品名: Steritest^®
• 包装: pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed
• パラメーター: 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.
• チューブの長さ: 850 mm
• 色: blue Canister Base
• Matrix: MF-Millipore^™
• ポアサイズ: 0.45 μm pore size
• 入力: liquid; sample type pharmaceutical(s)
• アプリケーション: pharmaceutical; sterility testing
• 適合性: For liquids in large vials.
• 輸送温度: ambient

詳細

詳細

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. This device ensures 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 device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest^® NEO devices. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.

アプリケーション

The Steritest^® NEO Device is used for sterility testing of liquids in large vials (double packed), which includes large volume parenterals and synthetic drugs, without antimicrobial agent.

特徴および利点

• 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.

包装

2 bags of 5 blisters per box

法的情報

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

安全性情報

• 保管分類コード: 11 - Combustible Solids
• WGK: WGK 2