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KP20A10FF1

Lifegard™ 2.0 µm nominal, Opticap® XL Capsule

Name: Lifegard™ 2.0 µm nominal, Opticap® XL Capsule
Brand: MM

Opticap® XL 10, inlet connection diam. 3/4 in., pore size 2.0 μm, cartridge nominal length 10 in. (25 cm)

Synonym(s):

Opticap XL10 Lifegard 2.0 μm 3/4 in. TC/TC, Lifegard^™ 2.0 µm nominal, Opticap^® XL Capsule

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About This Item

eCl@ss:

32031610

UNSPSC Code:

23151806

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Properties

Product Name

Opticap^® XL 10 CapsuleMedia: Lifegard^™ 2.0 µm Nominal, Chemistry: Borosilicate Glass Fiber (BGF)Inlet: 3/4 in. Sanitary FlangeOutlet: 3/4 in. Sanitary FlangeMax operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

borosilicate glass fiber (BGF) , 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^® XL 10

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

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

0.46 m²

inlet connection diam.

3/4 in.

inlet to outlet W

33.5 cm (13.2 in.)

outlet connection diam.

3/4 in.

impurities

≤1.0 EU/mL bacterial endotoxins (LAL test, Aqueous extraction), <0.1 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤225 mg/capsule

matrix

Lifegard^™

pore size

2.0 μm nominal pore size, 2.0 μm pore size

input

sample type liquid

fitting

inlet sanitary flange, outlet sanitary flange, (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

Description

General description

Device Configuration: Capsule

Features and Benefits

Format: Single Layer

Filter Grade: AP20

Packaging

Double Easy-Open bag

Preparation Note

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

Analysis Note

Gravimetric Extractables: after a 5 L flush and 24 hours in water at controlled room temperature

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection Guide
Storage Statement: Store in dry location
Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

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

Legal Information

Lifegard is a 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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Regulatory Information

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Global Trade Item Number

SKU	GTIN
KP20A10FF1	04053252501302