Opticap XL 300 Millipore Express SHF Sterile 0.2 μm 9/16 in. HB/HB

产品名称：

Opticap^® XL300 Millipore Express^® SHF
Opticap XL 300 Millipore Express SHF Sterile 0.2 μm 9/16 in. HB/HB

产品介绍：

产品说明

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 2.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/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 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
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.

产品性质

质量水平	400
物料	polyethersulfone polyethylene support 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
产品线	EMPROVE^® Filter
特点	hydrophilic
manufacturer/tradename	Millipore Express^®
参数	≤2.8 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	480 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 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 hose barb 14 mm (9/16 in.) inlet/outlet hose barb outlet hose barb

Opticap® XL300 Millipore Express® SHF

Opticap^® XL300 Millipore Express^® SHF