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Merck
CN

KHGES3FTT1

Millipore Express® SHR with prefilter 0.5/0.1µm, Opticap® XLT 30 Capsule

Fittings 1-1/2 in. TC, Sterile

别名:

Millipore Express® SHC，Opticap® XLT囊式

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UNSPSC Code:
23151806

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产品名称

无菌 Opticap XLT 30 Millipore Express SHC 0.5/0.2 µm TC/TC 1 件装 w/3/4" TC 顶部, Opticap® XLT, sterile, inlet connection diam. 1.5 in., pore size 0.5/0.2 μm, cartridge nominal length 30 in. (75 cm)

material

polyester support
polyethersulfone membrane
polypropylene housing
polypropylene vent cap
silicone seal

Quality Level

400

reg. compliance

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

sterility

sterile

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
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
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

cartridge nominal length

30 in. (75 cm)

device L

87.1 cm (34.3 in.)

filter diam.

10.7 cm (4.2 in.)

filtration area

1.63 m2 (17.4 ft2)

inlet connection diam.

1.5 in.

outlet connection diam.

1.5 in.

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

相关类别

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 63 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 ≥6 L

General description

Device Configuration: 取样皿滤膜
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.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 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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