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TZHVLV205

Steritest® NEO Device

For liquids in large vials., Red 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:

Red Base Steritest® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration

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この商品について

UNSPSC Code:
23151818
NACRES:
NB.24
eCl@ss:
32014001
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Quality Level

400

material

Nylon 66 adapter (for needle), PVC tubing (double lumen), PVDF 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

feature

Red base canister with a vented double needle for large glass containers with septa.

manufacturer/tradename

Steritest®

packaging

pkg of 10 blisters in 2 bags of 5 blisters per box, Double 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

red Canister Base

matrix

Durapore®

pore size

0.45 μm pore size

input

liquid
sample type pharmaceutical(s)

application(s)

pharmaceutical
sterility testing


compatibility

For liquids in large vials.

shipped in

ambient

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, minimizes false positives, and offers the highest levels of quality & 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 Steritest® NEO Double Packed Device for liquids in large vials 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 red canister base indicates low absorption. Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.

Application

Steritest® NEO Device is used for sterility testing of liquids in large vials containing 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 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.

Packaging

Pack of 10 double packed blisters in 2 bags of 5 blisters per box

Legal Information

Durapore is a registered 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

Still not finding the right product?

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保管分類

10-13 - German Storage Class 10 to 13

試験成績書（COA）

製品のロット番号またはバッチ番号を入力して、分析証明書（COA）を検索してください。ロット番号およびバッチ番号は、製品のラベル上の「Lot」または「Batch」という表記の後に記載されています。

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資料

Sterility Testing of Products with Antimicrobial Properties

Steritest® NEO device is ideal for sterility testing of antibiotics. The Steridilutor® NEO system is designed to dissolve and dilute drugs in vials whereas the Steridilutor® NEO device for the liquid transfer kit allows diluting liquids from open ampoules into a septum-equipped diluent container.

Steritest® NEO Membrane Filtration Sterility Test

Sterility testing is one of the most crucial steps in pharmaceutical product release. Regulatory-compliant membrane filtration sterility testing devices ensure the safety of pharmaceutical products.

関連コンテンツ

Steritest™ NEO Sterility
Steritest NEO Membrane Filtration Sterility Devices
Steritest® NEO 無菌試験用メンブレンフィルター

無菌試験は、医薬品販売において最も重要なステップの1つです。規制に準拠した無菌試験用メンブレンフィルターデバイスは、医薬品の安全性を確保します。

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グローバルトレードアイテム番号

カタログ番号GTIN
TZHVLV20504053252856006