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Steritest® NEO Device
| 产品编号： | 4102095 |
| 规格： | suitable for sterility testing, with single needle adapter for liquids in ampoules or collapsible bags, pkg of 10 blisters in 2 bags of 5 blisters per box, double packed |
| 包装规格： | 2 X 5 UNITS |
| 产品类别： | 进口试剂 |
| 品牌： | Millipore |
| 优惠价： | 立即咨询 |
基本信息
| eCl@ss | 32014001 |
| NACRES | NB.24 |
| General description【一般描述】 | 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 and 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 device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A single needle adapter enables an easy access to ampoules or collapsible bags. A separate vent needle is included for the transfer of the test product, culture media or rinsing buffer. The blue based canisters indicate mixed cellulose ester (MCE) membrane, which provides an optimal filtration flow rate for standard products. |
| Application【应用】 | The Steritest® NEO Device for liquids in ampoules or collapsible bags is used for sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity. |
| Legal Information【法律信息】 | 2 bags of 5 blisters per box |
产品性质
| Quality Level【质量水平】 | 400 |
| material【物料】 | 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【无菌性】 | sterile; γ-irradiated |
| manufacturer/tradename | Steritest® |
| packaging【包装】 | pkg of 10 blisters in 2 bags of 5 blisters per box, double packed |
| parameter【参数】 | 3.1 bar max. inlet pressure (45 psi) at 25 ℃ 45 ℃ max. temp. |
| tubing L | 850 mm |
| color【颜色】 | blue Canister Base |
| matrix【基质】 | MF-Millipore® |
| pore size【孔径】 | 0.45 μm pore size |
| input | sample type pharmaceutical(s) liquid |
| test parameters【试验参数】 | sample volume: 120 mL (graduation marks at 25, 50, 75 and 100 mL) |
| application(s) | pharmaceutical sterility testing |
| shipped in【运输】 | ambient |
产品说明
| 【免责声明】 | MF-Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany |
安全信息
| Storage Class Code【储存分类代码】 | 11 - Combustible Solids |
| WGK | WGK 2 |
