TZHADV210

Steritest^® NEO Device

For soluble powders in vials. Blue base canister with a vented double needle for small vials with septa.

• 동의어(들): Blue Base Steritest^® NEO device for sterility testing, Sterility testing device, membrane filtration device, membrane filtration canister, closed membrane filtration
• UNSPSC 코드: 23151818
• eCl@ss: 32014001
• NACRES: NB.24

속성

• material: 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)
• Quality Level: 400
• Agency: EP (2.6.1); JP (4.06); USP 71
• 무균: sterile; γ-irradiated
• 제조업체/상표: Steritest^®
• 포장: pkg of 10 blisters per box, Single packed
• 파라미터: 120 mL sample volume (graduation marks at 25, 50, 75 and 100 mL); 3.1 bar max. inlet pressure (45 psi) at 25 °C; 45 °C max. temp.
• 배관 길이(L): 850 mm
• 색상: blue Canister Base
• 기질: MF-Millipore^™
• 공극 크기: 0.45 μm pore size
• 입력: liquid; sample type pharmaceutical(s)
• 응용 분야: pharmaceutical; sterility testing
• 호환성: for use with Steritest^® Symbio FLEX Pump Kit, 2 media (SYMBFLE01); for use with Steritest^® Symbio ISL Pump Kit, 2 media (SYMBISL01); for use with Steritest^® Symbio LFH Pump Kit (SYMBLFH01)
• 배송 상태: ambient

설명

일반 설명

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 ensures that pharmaceutical products are never exposed to the environment during the testing process. This 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. A small diameter double needle adapter is used for small vials with septa. The blue based canisters indicate mixed cellulose esters (MCE) membrane, which provides an optimal filtration flow rate for standard products.

애플리케이션

The Steritest^® NEO Device is used for sterility testing of soluble powders in vials, without antimicrobial agents. The device simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters for further filtration.

특징 및 장점

• One-stop-shop for sterility testing with our devices, pumps, media, fluids, and services
• Steritest^® devices are manufactured in our Center of Excellence in Molsheim, France, with high-quality control standards maintaining the Certificate of Quality for each lot.
• New needle design

The design of this new needle has been optimized with short needle length, grips, and ridges to offer dexterity and security to the operator while piercing the small container

• Smarter workflow

The new Steritest^® NEO cartridge device benefits from all the improvements such as colored clamps, graduations for accurate volume measurement, optimized identification, and traceability with the new peel-off label

• Completely closed set up

Pharmaceutical products are never exposed to the environment during the testing process with Steritest^® NEO devices. Filtration, rinsing, media addition and incubation are conducted within a closed system.

• Consistent performance

100% integrity testing, strict physical and microbiological tests performed at every step of the assembly of the Steritest^® NEO device before release from manufacturing.

• New tubing disconnection tool

The Velax^® cutting clamps are mounted on all Steritest^® NEO devices and allow safe and easy cutting of the tubes.

포장

Pack of 10 single packed blisters per box

법적 정보

MF-Millipore is a trademark of Merck KGaA, Darmstadt, Germany

STERITEST is a registered trademark of Merck KGaA, Darmstadt, Germany

VELAX is a registered trademark of Merck KGaA, Darmstadt, Germany

안전성 정보

• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 2