Steritest^?NEO Device

半岛bd体育手机客户端 说明

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, offers the highest levels of quality and reliability, and 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 has vented double needle and simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters for further filtration. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.

应用

The Steritest^?NEO Device is used for sterility testing of soluble powders in ampoules, without antimicrobial agent. The device simultaneously dilutes and transfers the test products to the canister set.

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

半岛bd体育手机客户端 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 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	blue Canister Base
基质	MF-Millipore?
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

安全信息

储存分类代码	11 - Combustible Solids
WGK	WGK 2