Opticap Sterile XL4 Durapore 0.22 μm TC/HB

产品名称：

Opticap^® XL4 Durapore^®
Opticap Sterile XL4 Durapore 0.22 μm TC/HB

产品介绍：

产品说明

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

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).
Sterilization Method
Shipped sterile by gamma irradiation @ >25 kGray gamma exposure

分析说明

TOC/Conductivity
After sterilization and a controlled water flush, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 ºC.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² 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.

产品性质

质量水平	400
物料	PVDF polyester support polypropylene (gamma-stable) polypropylene housing polypropylene vent cap silicone outer O-ring silicone-coated EPDM rubber lead O-ring
reg. compliance	meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)
无菌性	sterile
产品线	EMPROVE^® Filter
特点	hydrophilic
manufacturer/tradename	Opticap^®
参数	≤4.6 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. differential pressure (40 psid) at 25 ℃ (Reverse; intermittent) 2.8 bar max. inlet pressure (40 psi) at 60 ℃ 25 ℃ max. inlet temp. 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	17.0 cm (6.7 in.)
cartridge nominal length	4 in. (10 cm)
直径	6.1 cm (2.4 in.)
过滤面积	0.18 m²
inlet connection diam.	1.5 in.
outlet connection diam.	9/16 in.
总尺寸	4 in.
杂质	≤0.5 EU/mL bacterial endotoxins (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
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 sanitary flange outlet hose barb 14 mm (9/16 in.) outlet hose barb

Opticap® XL4 Durapore®

Opticap^® XL4 Durapore^®