Opticap^?XL5 Durapore^?

半岛bd体育手机客户端 说明

一般描述

Device Configuration: 取样皿滤膜

包装

Double Easy-Open bag

其他说明

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

• Organism Retention: Microorganism
• Mode of Action: Filtration (size exclusion)
• Application: BioProcessing
• Intended Use: Reduction or removal of microorganism/bioburden
• Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore^?Membrane user guide
• Storage Statement: Store in dry location
• Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

制备说明

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
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

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Bacterial Retention
Samples were quantitatively retentive of a minimumBrevundimonas diminutachallenge concentration of 1 x 10? CFU/cm? using ASTM^?F838 methodology.

法律信息

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

免责声明

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

半岛bd体育手机客户端 性质

质量水平	400
物料	PVDF polypropylene polypropylene housing polypropylene support polypropylene vent cap silicone seal
reg. compliance	meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
无菌性	sterile
半岛bd体育手机客户端 线	EMPROVE?Filter
特点	hydrophilic
manufacturer/tradename	Opticap?
参数	≤6.6 mL/min air diffusion at 2.75 bar (40 psig) and 23 ℃ (in water) 1.0 bar max. differential pressure (15 psid) at 80 ℃ (Forward) 1.0 bar max. inlet pressure (15 psi) at 80 ℃ 2.8 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 3.4 bar max. differential pressure (50 psid) at 25 ℃ (Reverse; intermittent) 5.5 bar max. differential pressure (80 psid) at 25 ℃ (Forward) 5.5 bar max. inlet pressure (80 psi) at 23 ℃ 80 psig max. inlet pressure
长度	21.6 cm (8.5 in.)
cartridge nominal length	5 in. (12.5 cm)
直径	14.5 cm (5.7 in.)
过滤面积	0.35 m2
inlet connection diam.	1.5 in.
inlet to outlet W	21.6 cm (8.5 in.)
outlet connection diam.	1.5 in.
总尺寸	5 in.
杂质	≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
gravimetric extractables	≤15 mg/capsule
基质	Durapore?
孔径	0.22 μm nominal pore size 0.22 μm pore size
input	sample type liquid
bubble point	≥3450 mbar (50 psig), air with water at 23 ℃
配件	1/4 in. drain/vent hose barb (with double O-ring Seal) inlet sanitary flange 38 mm (1 1/2 in.) inlet/outlet sanitary flange outlet sanitary flange