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Merck
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KVGLA1ZTT1

Durapore® 0.22 µm，Opticap® XLT囊式

Opticap® XLT 10, inlet connection diam. 1.5 in., cartridge nominal length 10 in. (25 cm)

别名:

Opticap XLT 10 with Durapore - 10" 0.22 μm TC/TC, w/ gauge port 1pk

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UNSPSC Code:
23151806

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产品名称

Durapore® 0.22 µm，Opticap® XLT囊式, Opticap® XLT 10, inlet connection diam. 1.5 in., cartridge nominal length 10 in. (25 cm)

material

PVDF
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 10

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
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 (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)

sterile filtration: suitable

cartridge nominal length

10 in. (25 cm)

filtration area

0.73 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

≤25 mg/capsule

matrix

Durapore®

pore size

0.22 μm

input

sample type liquid

bubble point

≥3450 mbar (50 psig), air with water at 23 °C

fitting

3/4 in. gauge port
1/4 in. vent hose barb (with double O-ring Seal)
 (38 mm (1 1/2 in.) Sanitary Flange Inlet and Outlet)

Quality Level

400

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Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in water at controlled room temperature

General description

Device Configuration: 取样皿滤膜
T-line/Gauge Port: T-line with 3/4 in. Gauge Port T-line side

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.

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.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °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).

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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