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Merck
CN

KEGBG003FF3

Millipore Expresse™ SPG 0.2 µm, Opticap® XL Capsule

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

Synonym(s):

Millipore Express® SPG 0.2 µm, Opticap® XL Capsule, 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

Key Documents

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Product Name

Opticap® XL 300 Capsule Media: Millipore Express™ SPG 0.2 µm, Chemistry: Hydrophobic Polyethersulfone (PES) Inlet: 3/4 in. Sanitary Flange Outlet: 3/4 in. Sanitary Flange

material

polyethersulfone membrane
polyethylene support
polypropylene housing
silicone O-ring

Quality Level

400

sterility

non-sterile

sterilization compatibility

gamma compatible
x-ray compatible

product line

Opticap® XL

feature

hydrophobic

manufacturer/tradename

Opticap®

parameter

2.1 bar max. differential pressure (30 psid) at 4-40 °C (Reverse)
60 psid max. differential pressure (4.1 bar) at 4-40 °C (Forward)

technique(s)

gas filtration: suitable

filtration area

0.048 m2

impurities

<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

19 mm (3/4 in.) inlet sanitary flange
19 mm (3/4 in.) outlet sanitary flange

shipped in

ambient

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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 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.

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.

General description

Device Configuration: Capsule

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
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).

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
Express is a 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

Regulatory Information

新产品
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