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KW19A3THH1

Opticap® XLT 30 Capsule Media: Milligard® 1.2 µm Nominal

Chemistry: Mixed Cellulose Esters (MCE) Inlet: 5/8 in. Hose Barb Outlet: 5/8 in. Hose Barb T-line Max Operating Pressure: 80 psi @ 25 °C

別名:

Opticap XLT30 Milligard 1.2 μm 5/8 in. HB/HB, Milligard® 1.2 µm, Opticap® XLT Capsule

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eCl@ss:
32031610
UNSPSC Code:
23151806
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製品名

Opticap® XLT 30 Capsule Media: Milligard® 1.2 µm Nominal, Chemistry: Mixed Cellulose Esters (MCE) Inlet: 5/8 in. Hose Barb Outlet: 5/8 in. Hose Barb T-line Max Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

material

mixed cellulose esters (MCE) , polyester support, polypropylene , polypropylene housing, 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

87.1 cm (34.3 in.)

cartridge nominal length

30 in. (75 cm)

filtration area

2.5 m2

inlet connection diam.

5/8 in.

inlet to outlet W

19.8 cm (7.8 in.)

outlet connection diam.

5/8 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

≤165 mg/capsule

matrix

Milligard®

pore size

1.2 μm nominal pore size, 1.2 μm pore size

input

sample type liquid

fitting

inlet hose barb, outlet hose barb, (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

General description

Device Configuration: Capsule
T-line/Gauge Port: T-line

Features and Benefits

Filter Grade: Standard Milligard® Media
Format: Single 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 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥15 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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user 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

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

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保管分類

4.1B - Flammable solid hazardous materials

wgk

WGK 3

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