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Polysep™ II 2.0/1.2 µm nominal, Opticap® XLT Capsule

Name: Polysep™ II 2.0/1.2 µm nominal, Opticap® XLT Capsule
Brand: MM

Opticap® XLT 30, inlet connection diam. 1.5 in., pore size 2.0/1.2 μm, cartridge nominal length 30 in. (75 cm)

別名:

Oticap XLT 30 Polysep II - 30" 2.0/1.2μm TC/TC 1pk, Polysep^™ II 2.0/1.2 µm nominal, Opticap^® XLT Capsule

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この商品について

eCl@ss:

32031610

UNSPSC Code:

23151806

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特性

製品名

Polysep^™ II 2.0/1.2 µm（公称）、オプティキャップ（Opticap）^® XLTカプセル, Chemistry: Mixed Cellulose Esters (MCE)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-line with 3/4 in. Gauge Port T-line sideMax Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

material

borosilicate glass fiber (BGF) membrane, mixed cellulose esters (MCE) membrane, polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal

reg. compliance

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

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap^® XLT 30

feature

hydrophilic

manufacturer/tradename

Opticap^®

parameter

1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.75 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, 5.5 bar max. inlet pressure (80 psi) at 23 °C, 80 psig max. inlet pressure

technique(s)

prefiltration: suitable

L

34.3 in.

W

6.0 in.

cartridge nominal length

30 in. (75 cm)

filtration area

1.39 m²

inlet connection diam.

1.5 in.

outlet connection diam.

1.5 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

≤435 mg/capsule

matrix

Polysep^™ II

pore size

2.0/1.2 μm nominal pore size, 2.0/1.2 μm pore size

input

sample type liquid

fitting

inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

詳細

General description

Device Configuration: カプセル

T-line/Gauge Port: T-line with 3/4 in. Gauge Port T-line side

Features and Benefits

Format: Double Layer

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable

This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Gravimetric Extractables: after a 15 L flush and 24 hours in water at controlled room temperature

Other Notes

これらの製品はFDAの定めたGMP準拠の製造工場で製造されています。

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 to the first page of Visual Inspection Guide and introduction section of the Mixed cellulose esters Tech Brief
Storage Statement: Please refer to the Mixed cellulose esters Tech Brief
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Legal Information

OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Polysep is a trademark of Sigma-Aldrich Co. LLC

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保管分類

11 - Combustible Solids

wgk

WGK 2

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