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Millipore

Millipore Express® SPG 0.2 µm, Opticap® XL Capsule

Opticap® XL 300, inlet connection diam. 3/4 in., pore size 0.2 μm

Synonym(s):

Gamma Phobic Opticap® XL 300 Express SPG 0.2 sanitary flange

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690
NACRES:
NB.24

material

polyethersulfone membrane
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
polysulfone
silicone seal

Quality Level

400

sterility

irradiated
non-sterile

sterilization compatibility

gamma compatible

product line

Opticap® XL 300

feature

hydrophobic

manufacturer/tradename

Opticap®

parameter

2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
25 °C max. inlet temp.
4.1 bar max. inlet pressure (60 psi) at 23 °C
4.2 bar max. differential pressure (60 psid) at 25 °C (Forward)
60 psi max. differential pressure (4.1 bar) (continuous)
60 psig max. inlet pressure

technique(s)

gas filtration: suitable

L

11.9 cm (4.7 in.)

diam.

5.6 cm (2.2 in.)

filtration area

0.048 m2

inlet connection diam.

3/4 in.

inlet to outlet W

11.9 cm (4.7 in.)

outlet connection diam.

3/4 in.

impurities

≤0.25 EU/mL (LAL test, Aqueous extraction)
<0.25  EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤3 mg

matrix

Millipore Express® SPG

pore size

0.2 μm pore size

bubble point

≥1210 mbar (17.5 psig), air with 70/30% IPA/water at 23 °C

fitting

1/4 in. drain/vent hose barb (with double O-ring seal)
 inlet sanitary flange
 outlet sanitary flange
 (19 mm (3/4 in.) Sanitary Flange Inlet and Outlet)

shipped in

ambient

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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
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a Millipore Express 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 a 70/30% IPA/water mixture at controlled room temperature
HydroCorr: ≤0.16 mL/min @ 2.6 bar (38 psig)
TOC/Conductivity
After gamma irradiation and three autoclave cycles, the TOC was measured to be equal to or less than 3367 µg/device.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPORE EXPRESS 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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Certificates of Analysis (COA)

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