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安全信息

KPHLA04FH3

Millipore

Durapore® 0.45 µm，Opticap® XL囊式

Opticap® XL 4, inlet connection diam. 3/4 in., cartridge nominal length 4 in. (10 cm)

别名:

Opticap XL4 Durapore 0.45 μm without prefilter TC/HB

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About This Item

UNSPSC代码:
23151806

物料

PVDF
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

质量水平

400

管理合规性

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

无菌性

non-sterile

灭菌适用性

autoclavable compatible

产品线

Opticap® XL 4

特点

hydrophilic

制造商/商品名称

Opticap®

参数

≤4.5 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.4 bar max. differential pressure (50 psid) at 25 °C (Forward)
3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

技术

bioburden reduction: suitable

长度

7.7 in.

宽度

3.3 in.

纯化柱标称长度

4 in. (10 cm)

直径

8.4 cm (3.3 in.)

过滤面积

0.19 m2

入口接头直径

3/4 in.

入口至出口宽度

21.3 cm (8.4 in.)

出口接头直径

9/16 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)

重量萃取物

≤10 mg/capsule

基质

Durapore®

孔径

0.45 μm

输入

sample type liquid

泡点

≥1930 mbar (28 psig), air with water at 23 °C

配件

1/4 in. drain/vent hose barb (with double O-ring Seal)
 inlet sanitary flange
 outlet hose barb
 (19 mm (3/4 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

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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

法律信息

Durapore 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.

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