Merck
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KVEPS2TBB1

Millipore

Opticap® XL Capsule Filter

sterile, cartridge nominal length 20 in. (50 cm), filter diam. 10.7 cm (4.2 in.)

质量水平

400

物料

polyester support
polypropylene device
polypropylene housing
polypropylene vent cap
silicone seal

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

无菌性

sterile

特点

hydrophilic

manufacturer/tradename

Millipore Express®

参数

1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
1.0 bar max. inlet pressure (15 psi) at 80 °C
100 psi max. differential pressure (6.9 bar) (intermittent)
2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

cartridge nominal length

20 in. (50 cm)

device L

62.5 cm (24.6 in.)

device size

20 in.

过滤器直径

10.7 cm (4.2 in.)

filter filtration area

1.38 m2

杂质

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

基质

Millipore Express® SHR

孔径

0.1 μm pore size

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water

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一般描述

Device Configuration: Capsule
T-line/Gauge Port: T-line

包装

Double Easy-Open bag

制备说明

Sterilization Method:
3 autoclave cycles of 60 min at 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).

分析说明

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 3 L
TOC/Conductivity: After sterilization and a controlled water flush of 22 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.
Bacterial Retention: Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 107 CFU/cm2 using ASTM® F838 methodology.

其他说明

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

法律信息

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

Certificate of Analysis

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Certificate of Quality

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