产品说明
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 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 devices. The blue canister base indicates mixed esters of cellulose membrane. This membrane provides an optimal filtration flow rate for standard products.
应用
The Steritest® NEO Device for liquids in vials is used for sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity.
外形
Color Code: 蓝色
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
基本信息
| eCl@ss | 32014001 |
| NACRES | NB.24 |
产品性质
| 质量水平 | 400 |
| 物料 | blue base (canister) mixed cellulose esters (MCE) (for membrane filter) plain filter stainless steel (for needle) styrene-acrylonitrile (SAN) (for canister) |
| agency | EP (2.6.1) JP (4.06) USP (71) |
| 无菌性 | sterile; γ-irradiated |
| manufacturer/tradename | Steritest® |
| 包装 | pkg of 10 blisters per box, Single packed |
| 基质 | MF-Millipore® |
| 孔径 | 0.45 μm pore size |
| input | pharmaceutical(s) |
| 试验参数 | sample volume: 120 mL (graduation marks at 25, 50, 75 and 100 mL) |
| application(s) | pharmaceutical sterility testing |
| 运输 | ambient |
安全信息
| 储存分类代码 | 11 - Combustible Solids |
| WGK | WGK 2 |
