TZHVAB210
Steritest® NEO Device
For liquids in ampoules and collapsible bags., Red base canister with single needle for easy access., pkg of 10 blisters per box, 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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この商品について
Quality Level
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 single needle for easy access.
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
red Canister Base
matrix
Durapore®
pore size
0.45 μm pore size
input
sample type pharmaceutical(s)
application(s)
pharmaceutical
sterility testing
compatibility
For liquids in ampoules and collapsible bags., 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)
shipped in
ambient
General description
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.
Application
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
- Smarter workflow
- Completely closed set up
- Consistent performance
- New tubing disconnection tool
Packaging
Legal Information
試験成績書（COA）
製品のロット番号・バッチ番号を入力して、試験成績書（COA） を検索できます。ロット番号・バッチ番号は、製品ラベルに「Lot」または「Batch」に続いて記載されています。
資料
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.
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
The new Velax® cutting clamp to sever the tubing of a Steritest® NEO device makes sterility testing by membrane filtration safer and more convenient than ever before.
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。
グローバルトレードアイテム番号
| カタログ番号 | GTIN |
|---|---|
| TZHVAB210 | 04053252253539 |