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LAHL04TP6

Millipore

Durapore® 0.45 µm with Prefilter, Optiseal® Cartridge

OptiSeal® 4 in., filtration area 0.18 m2, matrix Durapore® (w/Prefilter)

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Synonym(s):
Optiseal Durapore Cartridge Filter 0.45 μm with prefilter
UNSPSC Code:
23151806
eCl@ss:
32031690

material

PVDF
mixed cellulose esters (MCE) prefilter
polypropylene
polypropylene support
silicone seal

Quality Level

400

reg. compliance

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

sterility

non-sterile

Sterilization Compatibility

autoclavable compatible
steam-in-place compatible

product line

OptiSeal® 4 in.

feature

hydrophilic

manufacturer/tradename

OptiSeal®

parameter

≤4 mL/min air diffusion at 1.5 bar (22 psig) and 23 °C (in water)
0.35 bar max. differential pressure (5 psid) at 121 °C (Forward)
0.35 bar max. inlet pressure (5 psi) at 121 °C (Forward)
3.5 bar max. differential pressure (50 psid) at 25 °C (Reverse)
3.5 bar max. differential pressure (50 psid) at 80 °C (Forward)
3.5 bar max. inlet pressure (50 psi) at 25 °C (Reverse)
3.5 bar max. inlet pressure (50 psi) at 80 °C (Forward)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 25 °C (Forward)

technique(s)

bioburden reduction: suitable

L

4 in.

cartridge nominal length

4 in. (10 cm)

filtration area

0.18 m2

impurities

≤0.5 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤15 mg/cartridge

matrix

Durapore® (w/Prefilter)

pore size

0.45 μm

input

sample type liquid

bubble point

≥1930 mbar (28 psig), air with water at 23 °C

cartridge code

not applicable

Related Categories

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

Other Notes

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
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 Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
10 autoclave cycles or SIP @ 121 °C for 30 min
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).

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥500 mL

Legal Information

Durapore is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTISEAL is a registered trademark of Merck KGaA, Darmstadt, Germany

WGK

WGK 3

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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