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Merck

TZHVAB210

Millipore

Steritest® NEO Device

For liquids in ampoules and collapsible bags. Red base canister with single needle for easy access. Single 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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About This Item

UNSPSCコード:
23151818
eCl@ss:
32014001
NACRES:
NB.24

物質

Nylon 66 adapter (for needle)
PVC tubing (double lumen)
PVDF membrane
plain filter
stainless steel (for needle)
styrene-acrylonitrile (SAN) (for canister)

品質水準

認証

EP (2.6.1)
JP (4.06)
USP 71

無菌性

sterile; γ-irradiated

メーカー/製品名

Steritest®

包装

pkg of 10 blisters per box, Single 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

red Canister Base

マトリックス

Durapore®

ポアサイズ

0.45 μm pore size

入力

sample type pharmaceutical(s)

アプリケーション

pharmaceutical
sterility testing

適合性

for use with Steritest® Symbio FLEX Pump Kit, 2 media (SYMBFLE01)
for use with Steritest® Symbio ISL Pump Kit, 2 media (SYMBISL01)
for use with Steritest® Symbio LFH Pump Kit (SYMBLFH01)

輸送温度

ambient

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, offers the highest levels of quality & reliability, and ensures that pharmaceutical products are not exposed to the environment. 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 separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The red canister base indicates low absorption Durapore® polyvinylidene fluoride (PVDF) membrane and specific drain design, to optimize the rising of products that inhibit microbial growth.

アプリケーション

The Steritest® NEO Device for Liquids Antibiotics is used for sterility testing of antibiotics and products containing antimicrobial agents. The red canister base indicates low absorption Durapore membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.

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 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.

包装

Pack of 10 single packed blisters per box

法的情報

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

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資料

Steritest™ NEO System – Specific Steritest™ NEO closed systems allow aseptic dissolution/dilution of product samples. The Steridilutor® NEO system is specifically designed to dissolve and dilute drugs in vials. The Steridilutor® NEO device for liquid transfer kit enables to dilute liquids from open ampoules into a diluent container with septum.

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