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KVVLG10FH1

Durapore^® 0.1 µm, Opticap^® XL Capsule

Name: Durapore<SUP>&#174;</SUP> 0.1 µm, Opticap<SUP>&#174;</SUP> XL Capsule
Brand: MM

Opticap^® XL 10, inlet connection diam. 3/4 in., cartridge nominal length 10 in. (25 cm)

别名:

Durapore^® 0.1 µm，Opticap^® XL囊式

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UNSPSC Code:

23151806

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属性

产品名称

Opticap 可γ辐照的除菌级 XL10 Durapore 0.1 µm 3/4 in.TC-9/16 in.HB, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 3/4 in. Sanitary FlangeOutlet: 9/16 in. Hose BarbMax. Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

PVDF , polyester support, polyethylene support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, silicone outer O-ring, silicone-coated EPDM rubber lead O-ring

reg. compliance

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

sterility

non-sterile

sterilization compatibility

gamma compatible

product line

Opticap^® XL 10

feature

gamma compatible, hydrophilic

manufacturer/tradename

Opticap^®

parameter

≤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

technique(s)

sterile filtration: suitable

L

33.5 cm (13.2 in.)

W

4.2 in.

cartridge nominal length

10 in. (25 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.73 m²

inlet connection diam.

3/4 in.

inlet to outlet W

33.5 cm (13.2 in.)

outlet connection diam.

9/16 in.

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤25 mg/capsule

matrix

Durapore^®

pore size

0.1 μm

input

sample type liquid

bubble point

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

fitting

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

说明

General description

Device Configuration: 取样皿滤膜

Packaging

Double Easy-Open bag

Preparation Note

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).

Analysis Note

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

Other Notes

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.

Replaces: KVVL01TC1

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Legal Information

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

Disclaimer

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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货号	GTIN
KVVLG10FH1	04053252263996