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Merck
CN

KGEPG3FBB1

Millipore Express® SHF 0.2µm, Opticap® XLT 30 Capsule

Fittings 1 in. HB/HB, Gamma Compatible

别名:

Millipore Express® SHF, Opticap® XLT Capsule

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHF，Opticap® XLT囊式, Chemistry: Hydrophilic Polyethersulfone (PES) Inlet: 1 in. Hose Barb Outlet: 1 in. Hose Barb T-line with 3/4 in. Gauge Port Max Operating Pressure: 80psi @ 25 °C

material

polyester support, polypropylene housing, polypropylene vent cap, silicone seal, polyethersulfone membrane, silicone O-ring

feature

hydrophilic

manufacturer/tradename

Millipore Express®

Quality Level

400

sterility

non-sterile

sterilization compatibility

autoclavable compatible
gamma compatible
x-ray compatible

product line

Opticap® XLT

impurities

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

matrix

Millipore Express® SHF

pore size

0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water

fitting

25 mm (1 in.) inlet hose barb, 25 mm (1 in.) outlet hose barb

reg. compliance

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

parameter

1 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

7.8 in.

cartridge nominal length

30 in. (75 cm)

device L

87.1 cm (34.3 in.)

filter diam.

10.7 cm (4.2 in.)

filter filtration area

1.71 m2 (18.4 ft2)

相关类别

General description

Device Configuration: Capsule
T-line/Gauge Port: T-line with 3/4 in. Gauge Port

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
3 autoclave cycles of 60 min at 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; 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 33 L, samples exhibited &#x3C 500 ppb TOC per USP &#x3C 643 &#x3C and &#x3C 1.3 μS/cm per USP &#x3C 645 &#x3C at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 4.5 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

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

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