半岛bd体育手机客户端 说明

一般描述

Device Configuration: 取样皿滤膜

其他说明

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use

• Organism Retention: Bacterial
• Mode of Action: Filtration (size exclusion)
• Application: Protein purification
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer installation and wetting sections of OPTISCALE^?-25 user guide
• Storage Statement: Please refer OPTISCALE^?-25 user guide
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
1 autoclave cycle of 60 min @ 123 °C
This product was manufactured with a Durapore^?membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

分析说明

TOC/Conductivity
After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 ?S/cm per USP <64>.
This product was tested and passes the USP <78> test for particulates in injectables.

法律信息

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Luer-Lok is a registered trademark of Becton-Dickinson & Co.
OPTISCALE is a registered trademark of Merck KGaA, Darmstadt, Germany

基本信息

eCl@ss	32031610
NACRES	NB.24

半岛bd体育手机客户端 性质

物料	PVDF membrane polypropylene polypropylene support polypropylene vent cap
质量水平	400
reg. compliance	meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
无菌性	sterile
特点	hydrophilic
manufacturer/tradename	OptiScale?
参数	4.1 bar max. inlet pressure (60 psi) at 25 ℃ 60 psi max. differential pressure (4.1 bar) at 25 ℃ (forward)
长度	3.9 cm (1.52 in.)
直径	3.1 cm (1.2 in.)
过滤面积	3.5 cm2
杂质	≤0.25 EU/mL (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质	Durapore?
孔径	0.22 μm nominal pore size 0.22 μm pore size
input	sample type liquid
配件	female Luer-Lok?inlet connection male Luer-Lok?outlet connection
运输	ambient