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Steritest® NEO Device
| 产品编号： | 4102099 |
| 规格： | suitable for sterility testing, with vented needle adapter for liquids in large vials, 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 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 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. The device is gamma sterilized and double packed for the quick transfer into sterility testing environments, simplifying decontamination procedures and saving time. A vented needle adapter vents and transfers the test product from large volume containers with a septum to the Steritest® NEO devices. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products. |
| Application【应用】 | The Steritest® NEO Device is used for sterility testing of liquids in large vials (double packed), which includes large volume parenterals and synthetic drugs, without antimicrobial agent. |
| Legal Information【法律信息】 | MF-Millipore is a registered trademark of Merck KGaA, Darmstadt, Germany STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany |
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 | liquid sample type pharmaceutical(s) |
| 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 |
安全信息
| Storage Class Code【储存分类代码】 | 11 - Combustible Solids |
| WGK | WGK 2 |
