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KPHLA2TTT1

Durapore® 0.45 µm, Opticap® XLT Capsule

Opticap® XLT 20, inlet connection diam. 1.5 in., cartridge nominal length 20 in. (50 cm)

동의어(들):

Opticap XLT20 Durapore 0.45 m without prefilter 1-1/2 in. TC/TC without gauge port, Durapore® 0.45 µm, Opticap® XLT Capsule

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제품정보 (DICE 배송 시 비용 별도)

UNSPSC Code:
23151806
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제품 이름

Opticap® XLT 20 CapsuleMedia: Durapore® 0.45 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80psi @ 25 °C

Quality Segment

400

material

PVDF , 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 20

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.8 bar max. inlet pressure (40 psi) at 60 °C, 25 °C max. inlet temp., 3.4 bar max. differential pressure (50 psid) at 25 °C (Forward), 3.4 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent), 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)

diam.

10.7 cm (4.2 in.)

filtration area

1.4 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

≤50 mg/capsule

matrix

Durapore®

pore size

0.45 μm

input

sample type liquid

bubble point

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

fitting

1/4 in. drain/vent hose barb (with double O-ring Seal), inlet sanitary flange, outlet sanitary flange, (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

General description

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

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; 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

Gravimetric Extractables: after 24 hours in water at controlled room temperature

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

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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