Merck
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KHGEG03TB3

Millipore

Opticap® Gamma Compatible XL Capsule Filter

cartridge nominal length 3 in. (7.5 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
polysulfone device
silicone seal

reg. compliance

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

产品线

EMPROVE® Filter

特点

hydrophilic

manufacturer/tradename

Millipore Express®

参数

≤7.6 mL/min air diffusion at 2.8 bar (40 psig) (in water)
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 25 °C
6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
6.9 bar max. inlet pressure (100 psi) at 25 °C (intermittent)
80 psi max. differential pressure (5.5 bar) (continuous)
80 psig max. inlet pressure

cartridge nominal length

3 in. (7.5 cm)

device L

17.3 cm (6.8 in.)

device size

3 in.

过滤器直径

10.7 cm (4.2 in.)

filter filtration area

0.13 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® SHC

pore size

0.5/0.2 μm pore size

bubble point

≥4000 mbar (58 psig), air with water

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一般描述

Device Configuration: Capsule

包装

Double Easy-Open bag

制备说明

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).
Sterilization Method:
Gamma Compatible to 45 kGy. May be autoclaved for 3 cycles of 60 min at 123 °C; not in-line steam sterilizable

分析说明

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 2 L
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 5.0 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.

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
Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
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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