Opticap^?XL300 Millipore Express^?SHC

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 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 2.0 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.

基本信息

eCl@ss

32031690

半岛bd体育手机客户端 性质

质量水平	400
物料	polyethersulfone membrane polyethylene support polypropylene (gamma-stable) polypropylene housing polypropylene vent cap (Gamma stable) 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	≤1.9 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 23 ℃ 6.9 bar max. differential pressure (100 psid) at 25 ℃ (Forward; intermittent) 6.9 bar max. inlet pressure (100 psi) at 23 ℃ (intermittent) 80 psi max. differential pressure (5.5 bar) (continuous) 80 psig max. inlet pressure
长度	11.9 cm (4.7 in.)
cartridge nominal length	4.7 in. (11.9 cm)
直径	5.6 cm (2.2 in.)
过滤面积	290 cm2
inlet connection diam.	9/16 in.
inlet to outlet W	11.9 cm (4.7 in.)
outlet connection diam.	9/16 in.
杂质	≤0.25 EU/mL (LAL test, Aqueous extraction) <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
基质	Millipore Express?SHC
pore size	0.5/0.2 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 hose barb 14 mm ( 9/16 in.) inlet/outlet hose barb outlet hose barb