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Merck
CN

KVHLA2THH1

Durapore® 0.45 µm，带预滤器，Opticap® XL囊式

cartridge nominal length 20 in. (50 cm), filter diam. 4.2 in. (10.7 cm), pore size 0.45 μm

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UNSPSC Code:
23151806

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material

mixed cellulose esters (MCE) prefilter, polypropylene device, polypropylene housing, polypropylene support, polypropylene vent cap

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

sterility

non-sterile

sterilization compatibility

autoclavable compatible

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

max. inlet temp. at 25 °C, ≤15 mL/min air diffusion at 1.5 bar (22 psig) (in water), 1.05 bar max. differential pressure (15 psid) at 80 °C (Forward), 2.75 bar max. inlet pressure (40 psi) at 60 °C, 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)

bioburden reduction: suitable

cartridge nominal length

20 in. (50 cm)

device size

20 in.

filter diam.

4.2 in. (10.7 cm)

filter filtration area

1.2 m2

inlet to outlet width

24.6 in. (62.5 cm)

impurities

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

matrix

Durapore®

pore size

0.45 μm pore size

bubble point

≥1930 mbar (28 psig), air with water at 23 °C

fitting

1/4 in. drain/vent connection (with double O-ring Seal), (16 mm (5?8 in.) Hose Barb Inlet and Outlet)

General description

Device Configuration: Cartridge
Cartridge Type: Liquid

Features and Benefits

T-line/Gauge Port: T-line

Preparation Note

Sterilization Method: Capsule integrity was maintained after 3 autoclave cyclces of 60 minutes at 126 °C.
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

Effluent was negative after a water flush of 1 L per autoclaved sample
Gravimetric Extractables: ≤ 50 mg per capsule after 24 hours in water at controlled room temperature.
Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.

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

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

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