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Merck
CN

KHGES2FTT1

Millipore Express® SHC 0.5/0.2µm, Opticap® XLT 20 Capsule

Fittings 1-1/2 in. TC, Sterile

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UNSPSC Code:
23151806

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产品名称

Millipore Express® SHC，Opticap® XLT囊式, Opticap® XLT, sterile, cartridge nominal length 20 in. (50 cm), filter diam. 10.7 cm (4.2 in.)

sterility

sterile

material

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

cartridge nominal length

20 in. (50 cm)

Quality Level

400

reg. compliance

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

sterilization compatibility

autoclavable compatible

product line

Opticap® XLT

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

1 bar max. differential pressure (15 psi) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
2.1 bar max. differential pressure (30 psi) at 25 °C (Reverse; intermittent)
2.8 bar max. inlet pressure (40 psi) at 60 °C
5.5 bar max. differential pressure (80 psi) at 25 °C (Forward)
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 23 °C (intermittent)

technique(s)

sterile filtration: suitable

L

62.5 cm (24.6 in.)

device size

20 in.

filter diam.

10.7 cm (4.2 in.)

filter filtration area

1.08 m2 (11.6 ft2)

impurities

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

matrix

Millipore Express® SHC

pore size

0.5/0.2 μm pore size

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

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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.
TOC/Conductivity: After sterilization and a controlled water flush of 42 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 L

General description

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

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

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).

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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