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. 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.
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.
包装
2 bags of 5 blisters per box
外形
Color Code: 蓝色
制备说明
Sterilization Method
伽马射线灭菌
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 | 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 |
| 无菌性 | sterile; γ-irradiated |
| manufacturer/tradename | Steritest® |
| 包装 | pkg of 10 blisters in 2 bags of 5 blisters per box, double packed |
| 参数 | 3.1 bar max. inlet pressure (45 psi) at 25 ℃ 45 ℃ max. temp. |
| tubing L | 850 mm |
| 颜色 | blue Canister Base |
| 基质 | MF-Millipore® |
| 孔径 | 0.45 μm pore size |
| input | sample type pharmaceutical(s) liquid |
| 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 |
