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Merck

MFGL06SL3

Millipore

Durapore® 0.22 µm, Millipak® Final Fill灌装囊式过滤器

Millipak® Final Fill 60, sterile; γ-irradiated

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About This Item

分類程式碼代碼:
23151806

材料

polysulfone device
polysulfone support

品質等級

agency

meets EP 2.6.14
meets JP 4.01
meets USP 85

無菌

irradiated
sterile; γ-irradiated

產品線

Millipak® Final Fill 60

特點

hydrophilic

製造商/商標名

Millipak®

參數

1.51 L/min flow rate at 0.86 bar (ΔP)
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
5.5 bar max. inlet pressure (80 psi) at 25 °C
60 L process volume
80 psi max. differential pressure (5.5 bar) at 25 °C (Forward)

技術

sterile filtration: suitable

過濾器過濾面積

300 cm2

雜質

<0.25 EU/mL USP bacterial endotoxins (LAL test, per device; aqueous extraction)
<0.25 EU/mL bacterial endotoxins (LAL test, per device; aqueous extraction)

基質

Durapore®

孔徑

0.22 μm pore size

起泡點

≥50 psi (3450 mbar), air with water

接頭

(38 mm (1 1/2 in.) Sanitary Flange Inlet and 13 mm (1/2 in.) Hose Barb Outlet)

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一般說明

Device Configuration: Gamma Gold Capsule

包裝

Double Easy-Open bag

準備報告

Sterilization Method: Device integrity and retention was maintained after 3 autoclave cycles of 90 minutes at 126  °C. Devices can withstand a dose ≤40  kGy gamma exposure.

This product was manufactured with a Durapore® membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6), validated based on large volume parenteral specifications as detailed in USP 788 Particulate Matter in Injections

分析報告

Bacterial Grow-Through: Quantitative retention of 1 x 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® F838 methodology.

其他說明

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 general guidelines section of user guide shipped with this product
  • Storage Statement: Please refer user guide shipped with this product
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations

These products are manufactured in a facility which is certified to ISO 9001:2015 Quality Management Systems.

法律資訊

ASTM is a registered trademark of American Society for Testing and Materials
ATCC is a registered trademark of American Type Culture Collection
Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
MILLIPAK is a registered trademark of Merck KGaA, Darmstadt, Germany

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