Merck
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MFGB02GH3

Millipore

Millipak® Final Fill 20 Filter Unit

Quality Level

material

polysulfone device
polysulfone support

Agency

meets EP 2.6.14
meets JP 4.01
meets USP 85

sterility

non-sterile

feature

hydrophilic

manufacturer/tradename

Millipak®

parameter

0.35 bar max. differential pressure (5 psid) at 121 °C (Reverse)
0.51 L/min flow rate at 0.69 bar (ΔP)
10 psi max. differential pressure (0.7 bar) at 25 °C (Reverse)
20 L process volume
25 psi max. differential pressure (1.7 bar) at 80 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse; intermittent)
5.5 bar max. inlet pressure (80 psi) at 25 °C
50 psi max. differential pressure (3.5 bar) at 25 °C (Forward)
60 psi max. differential pressure (4.1 bar) at 25 °C (Forward)

filter filtration area

100 cm2

impurities

<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)

matrix

Durapore®

pore size

0.22 μm pore size

fitting

1/4 in. (6 mm) inlet connection (stepped hose barb)
1/4 in. (6 mm) outlet connection (stepped hose barb)

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General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

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

Analysis Note

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

Other Notes

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

Legal Information

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

Certificate of Analysis

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Certificate of Quality

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