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KVVLA1THH1 Millipore

Opticap XLT10 Durapore 0.1 µm 5/8 in. HB/HB

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Properties

Quality Level   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   sterile
feature   hydrophilic
mfr. no.   Opticap®
parameter   ≤20 mL/min air diffusion at 3.9 bar (56 psig) and 23 °C (in water)
  1.0 bar max. inlet pressure (15 psi) at 80 °C
  1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
  2.8 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 (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
L   37.6 cm (14.8 in.)
cartridge nominal length   10 in. (25 cm)
diam.   10.7 cm (4.2 in.)
filtration area   0.69 m2
inlet connection diam.   5/8 in.
inlet to outlet W   19.8 cm (7.8 in.)
outlet connection diam.   5/8 in.
overall size   10 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   0.1 μm nominal pore size
  0.1 μm pore size
input   sample type liquid
bubble point   ≥4830 mbar (70 psig), air with water at 23 °C
fitting   1/4 in. drain/vent hose barb (with double O-ring Seal)
  inlet hose barb
  16 mm (5/8 in.) inlet/outlet hose barb
  outlet hose barb

Description

General description

Device Configuration: Capsule

T-line/Gauge Port: T-line

Packaging

Double Easy-Open bag

Other Notes

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

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.

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

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

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

Durapore 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.

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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