物料
Nylon 66 adapter (for needle)
PVC tubing (double lumen)
PVDF membrane
plain filter
stainless steel (for needle)
styrene-acrylonitrile (SAN) (for canister)
质量水平
Agency
EP (2.6.1)
JP (4.06)
USP 71
无菌性
sterile; γ-irradiated
特点
Red base canister with vented double needle for small vials with septa.
制造商/商品名称
Steritest®
包装
pkg of 10 blisters in 2 bags of 5 blisters per box, Double packed
参数
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.
管长度
850 mm
颜色
red Canister Base
基质
Durapore®
孔径
0.45 μm pore size
输入
sample type pharmaceutical(s)
应用
pharmaceutical
sterility testing
相容性
For soluble powders in vials with septa.
运输
ambient
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 & 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. The device simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters. A small diameter double needle adapter is used for small vials with septum. 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.
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 & 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. The device simultaneously dissolves/dilutes the sample in sterile diluent and transfers the resulting solution to canisters. A small diameter double needle adapter is used for small vials with septum. 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 is used for sterility testing of antibiotics and products with antimicrobial activity that require dilution or dissolution.
特点和优势
- 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
- Smarter workflow
- Completely closed set up
- Consistent performance
- New tubing disconnection tool
包装
Pack of 10 double packed blisters in 2 bags of 5 blisters per box
法律信息
Durapore is a registered 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
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