製品名
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 per box, Single packed
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 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)
liquid
application(s)
pharmaceutical
sterility testing
compatibility
For liquids in large vials.
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
Quality Level
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
General description
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 device. The red canister base indicates low absorption Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rising of products that inhibit microbial growth. The canister capacity of 120 mL allows to test larger volumes.
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 |
|---|---|
| TZHVLV210 | 04053252487248 |
ライフサイエンス、有機合成、材料科学、クロマトグラフィー、分析など、あらゆる分野の研究に経験のあるメンバーがおります。.
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