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KGEPG03TT3

Millipore Express® SHF 0.2µm, Opticap® XL 3 Capsule

Fittings 1-1/2 in. TC/TC, Gamma Compatible

别名:

Millipore Express® SHF, Opticap® XL 囊式

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UNSPSC Code:
23151806
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产品名称

Opticap XL3 Millipore Express SHF 可γ辐照 0.2 µm 1-1/2 in.TC/TC, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 1-1/2 in. Sanitary Flange Outlet: 1-1/2 in. Sanitary Flange Max Operating Pressure: 80 psi @ 25 °C

Quality Level

400

material

polyester support, polypropylene (gamma-stable), polypropylene housing, polypropylene vent cap, polysulfone , polyethersulfone membrane, silicone O-ring, 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
gamma compatible
x-ray compatible

product line

Opticap® XL

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1.0 bar max. differential pressure (15 psi) at 80 °C, 1.0 bar max. inlet pressure (15 psi) at 80 °C, 2.8 bar max. inlet pressure (40 psi) at 60 °C, 5.5 bar max. differential pressure (80 psi) at 25 °C, 5.5 bar max. inlet pressure (80 psi) at 25 °C, 6.9 bar max. differential pressure (100 psi) at 25 °C (Forward; intermittent), 6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)

technique(s)

sterile filtration: suitable

W

4.2 in.

cartridge nominal length

3 in. (7.5 cm)

device L

17.3 cm (6.8 in.)

filter diam.

10.7 cm (4.2 in.)

filtration area

0.17 m2 (1.8 ft2)

inlet connection diam.

1.5 in.

inlet to outlet W

17.3 cm (6.8 in.)

outlet connection diam.

1.5 in.

impurities

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

matrix

Millipore Express® SHF

pore size

0.2 μm

bubble point

≥4000 mbar (58 psig), air with water at 23 °C

fitting

38 mm (1 1/2 in.) inlet sanitary flange, 38 mm (1 1/2 in.) outlet sanitary flange

General description

Device Configuration: 取样皿滤膜

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).

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.
TOC/Conductivity
After sterilization and a controlled water flush of 3.5 L, samples exhibited less than 500 ppb TOC per USP <64> and less than 1.3 µS/cm per USP <64> at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

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 installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules 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.

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials
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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全球贸易项目编号

货号GTIN
KGEPG03TT304053252500503