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KPHLA05HH1

Millipore

Durapore® 0.45 µm, Opticap® XL Capsule

Opticap® XL 5, inlet connection diam. 9/16 in., cartridge nominal length 5 in. (12.5 cm)

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Synonym(s):
Opticap XL5 Durapore 0.45 μm without prefilter 9/16 in. HB/HB

material

PVDF
polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Quality Level

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® XL 5

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

≤7.5 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water)
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

L

8.5 in.

W

4.2 in.

cartridge nominal length

5 in. (12.5 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.35 m2

inlet connection diam.

9/16 in.

inlet to outlet W

21.3 cm (8.4 in.)

outlet connection diam.

9/16 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

≤15 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 hose barb
outlet hose barb
(14 mm (9/16 in.) Hose Barb Inlet and Outlet)

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General description

Device Configuration: Capsule

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

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

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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