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SteriSecureTM Device
产品性质
Quality Level【质量水平】 | 400 |
material【物料】 | PVC tubing mixed cellulose esters (HA) membrane stainless steel needle styrene-acrylonitrile (SAN) (canister) |
agency | ChP |
sterility【无菌性】 | sterile; γ-irradiated |
manufacturer/tradename | SteriSecure™ |
parameter【参数】 | max. pressure at 3.15 bar and 25 ℃ 45 ℃ max. temp. |
L【长度】 | 850 mm |
pore size【孔径】 | 0.45 μm (Canister membrane) |
input | liquid |
application(s) | pharmaceutical sterility testing |
compatibility【相容性】 | for use with Steritest® systems |
基本信息
General description【一般描述】 | The SteriSecure™ Device for ampoules and bags is designed for sterility testing of large volume parenterals and synthetic drugs. The SteriSecure™ Device for liquids in ampoules or collapsible bags includes a single needle for easy access to ampoules and a separate vent needle. The closed system minimizes false positives and offers the highest level of quality and reliability. This device ensures that pharmaceutical products are never exposed to the environment during the testing process. This membrane provides an optimal filtration flow rate for standard products. 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. |
Application【应用】 | The SteriSecure™ Device for ampoules and bags is used during the testing of pharmaceutical products in ampoules or collapsible bags for streamlining the workflow and increasing safety during sterility testing. |
Legal Information【法律信息】 | STERISECURE is a 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 3 |