Quality Level
material
Nylon 66 adapter (for needle), PVC tubing (double lumen), mixed cellulose esters (MCE) 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
Blue 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
blue Canister Base
matrix
MF-Millipore™
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
Steritest® NEO设备是一种膜过滤设备,用于可过滤药品的无菌测试。该设备简化了从处理到可追溯性的测试的各个方面。封闭式系统最大程度地减少了假阳性,并提供了最高水平的质量和可靠性。该设备确保测试过程中药品不会暴露于环境中。该测试系统与Steritest ®Symbio泵、专用附件以及高品质培养基和冲洗液一起使用时,可提供经过优化且完全符合法规的测试过程。该设备经过伽马辐照灭菌,采用双层包装,可快速转移到无菌测试环境中,简化了净化程序并节省了时间。带通气孔的针头适配器通气并将供试品从带隔膜的大容量容器转移至Steritest® NEO装置。带蓝色底座的罐表示混合纤维素酯(MCE)膜,该膜为标准产品提供了最佳的过滤流速。
Application
Features and Benefits
- 使用我们的设备、泵、介质、流体和服务进行无菌检测的一站式服务
- Steritest®设备是在我们位于法国莫尔塞姆的卓越中心制造的,每个批次都有高质量的控制标准,并保持质量证书。
- 新型针头设计
- 更智能的工作流程
- 完全封闭设置
- 一致的性能
- 新的管路切断工具
Packaging
Legal Information
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存储类别
11 - Combustible Solids
wgk
WGK 2
商品
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.
全球贸易项目编号
| 货号 | GTIN |
|---|---|
| TZHALV205 | 04053252385827 |