Opticap^?XL5 Millipore Express^?SHF

半岛bd体育手机客户端 说明

一般描述

Device Configuration: 取样皿滤膜
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.

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 installation section of OPTICAP^?XL Capsules and OPTICAP^?XLT Capsules 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 Millipore Express^?membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable

分析说明

TOC/Conductivity
After sterilization and a controlled water flush of 6.0 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 ?S/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
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
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS 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	polyester support polyethersulfone polypropylene (gamma-stable) polypropylene housing polypropylene vent cap polysulfone 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	Millipore Express?
参数	≤17.4 mL/min air diffusion at 2.8 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 ℃ 100 psi max. differential pressure (6.9 bar) (intermittent) 2.1 bar max. differential pressure (30 psid) at 25 ℃ (Reverse; intermittent) 2.75 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 25 ℃ 6.9 bar max. differential pressure (100 psid) at 25 ℃ (Forward; intermittent) 6.9 bar max. inlet pressure (100 psi) at 25 ℃ (intermittent) 80 psi max. differential pressure (5.5 bar) (continuous) 80 psig max. inlet pressure
长度	21.6 cm (8.5 in.)
cartridge nominal length	5 in. (12.5 cm)
直径	10.7 cm (4.2 in.)
过滤面积	0.31 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	≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质	Millipore Express?SHF
孔径	0.2 μm nominal pore size 0.2 μm pore size
bubble point	≥4000 mbar (58 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