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安全信息

KVVLG1TTT1

Millipore

Durapore® 0.1 µm，Opticap® XLT囊式

Opticap® XLT 10, inlet connection diam. 1.5 in., cartridge nominal length 10 in. (25 cm)

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别名:
Opticap Gamma Compatible Sterilizing Grade XLT10 Durapore 0.1 μm 1-1/2 in. TC/TC

物料

PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
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

irradiated
non-sterile

灭菌适用性

gamma compatible

产品线

Opticap® XLT 10

特点

gamma compatible
hydrophilic

制造商/商品名称

Opticap®

参数

≤21.1 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
2.8 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

技术

sterile filtration: suitable

长度

37.6 cm (14.8 in.)

宽度

6.0 in.

纯化柱标称长度

10 in. (25 cm)

直径

10.7 cm (4.2 in.)

过滤面积

0.73 m2

入口接头直径

1.5 in.

入口至出口宽度

15.2 cm (6.0 in.)

出口接头直径

1.5 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

≤25 mg/capsule

基质

Durapore®

孔径

0.1 μm

输入

sample type liquid

泡点

≥4830 mbar (70 psig), air with water at 23 °C

配件

1/4 in. drain/vent hose barb (with double O-ring Seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

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一般描述

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line

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; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

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
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.

法规信息

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