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LAHL04TP6

Optiseal® Cartridge Media: Durapore® w/Prefilter 0.45 µm

Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 4 in.

Synonym(s):

Optiseal Durapore Cartridge Filter 0.45 μm with prefilter, Durapore® 0.45 µm with Prefilter, Optiseal® Cartridge

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Optiseal® Cartridge Media: Durapore® w/Prefilter 0.45 µm, Chemistry: Hydrophilic Polyvinylidene Fluoride (PVDF) Configuration: 4 in.

Quality Level

400

material

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

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

General description

Device Configuration: Cartridge

Packaging

Double Easy-Open bag

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

Other Notes

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.

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Legal Information

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

Storage Class

4.1B - Flammable solid hazardous materials

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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Global Trade Item Number

SKUGTIN
LAHL04TP604053252603648