MSP010056

Steritest^® NEO Device

For liquids in large vials with septa., Blue base canister with vented needle adapter, pkg of 10 blisters per box, Single packed

• 别名: Blue Base Steritest^® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration
• 分類程式碼代碼: 23151818
• eCl@ss: 32014001
• NACRES: NB.24

属性

• 材料: blue base (canister); mixed cellulose esters (MCE) (for membrane filter); plain filter; stainless steel (for needle); styrene-acrylonitrile (SAN) (for canister)
• 品質等級: 400
• agency: EP (2.6.1); JP (4.06); USP (71)
• 無菌: sterile; γ-irradiated
• 特點: Blue base canister with vented needle adapter
• 製造商／商標名: Steritest^®
• 包裝: pkg of 10 blisters per box, Single packed
• 參數: 120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL)
• 顏色: blue Canister Base
• 基質: MF-Millipore^™
• 孔徑: 0.45 μm pore size
• 輸入: pharmaceutical(s)
• 應用: pharmaceutical; sterility testing
• 相容性: For liquids in large vials with septa.
• 運輸包裝: ambient

说明

一般說明

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 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. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest^® NEO devices. The blue canister base indicates mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products.

應用

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

特點和優勢

• 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.

包裝

Pack of 10 single packed blisters per box

法律資訊

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

安全信息

• 儲存類別代碼: 11 - Combustible Solids
• 水污染物質分類（WGK）: WGK 2