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 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. Steritest® NEO Device for medical devices provides three adapters: male Luer, female Luer or single needle allow connection to a variety of test devices. A separate vent needle is included for the transfer of the test product, culture media or rinse buffer. The Steritest® NEO Device for medical devices can be used with Novaseptum® for sterile sampling devices. The red canister base indicates low absorption. Durapore® hydrophilic Poly vinylidene fluoride (PVDF) membrane and specific drain design. This optimizes the rinsing of products that inhibit microbial growth.
应用
Steritest® NEO Device for medical devices and collapsible bags is used for sterility testing of medical devices, collapsible bags and products with antimicrobial agents.
外形
Color Code: 红色
法律信息
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
NOVASEPTUM is a registered trademark of Millipore AB - Sweden
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 | 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 |
| 无菌性 | sterile; γ-irradiated |
| manufacturer/tradename | Steritest® |
| 包装 | pkg of 10 blisters per box, Single packed |
| 参数 | 3.1 bar max. inlet pressure (45 psi) at 25 ℃ 45 ℃ max. temp. |
| tubing L | 850 mm |
| 颜色 | red Canister Base |
| 基质 | Durapore® |
| 孔径 | 0.45 μm pore size |
| input | sample type 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 |
Sigma-Aldrich
m.cnreagent.com
