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Merck

KW19A04HH3

Milligard® 1.2 µm, Opticap® XL Capsule

Opticap® XL 4, inlet connection diam. 9/16 in., pore size 1.2 μm, cartridge nominal length 4 in. (10 cm)

Synonym(s):

Opticap XL4 Milligard 1.2 μm 9/16 in. HB/HB

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About This Item

eCl@ss:
32031610
UNSPSC Code:
23151806

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Product Name

Milligard® 1.2 µm, Opticap® XL Capsule, Opticap® XL 4, inlet connection diam. 9/16 in., pore size 1.2 μm, cartridge nominal length 4 in. (10 cm)

material

mixed cellulose esters (MCE)
polyester support
polypropylene
polypropylene housing
polypropylene vent cap
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

product line

Opticap® XL 4

feature

hydrophilic

manufacturer/tradename

Opticap®

parameter

1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
3.5 bar max. differential pressure (50 psid) at 25 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

prefiltration: suitable

L

19.6 cm (7.7 in.)

W

3.3 in.

cartridge nominal length

4 in. (10 cm)

diam.

12.5 cm (4.9 in.)

filtration area

0.2 m2

inlet connection diam.

9/16 in.

inlet to outlet W

19.6 cm (7.7 in.)

outlet connection diam.

9/16 in.

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

≤25 mg/capsule

matrix

Milligard®

pore size

1.2 μm nominal pore size
1.2 μm pore size

input

sample type liquid

fitting

inlet hose barb
 outlet hose barb
 (14 mm (9/16 in.) Hose Barb Inlet and Outlet)

Quality Level

400

Related Categories

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 ≥1 L

Disclaimer

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

Features and Benefits

Filter Grade: Standard Milligard® Media
Format: Single Layer

General description

Device Configuration: Capsule

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 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.

Replaces: KW1904HB1
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 121 °C; not in-line steam sterilizable
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Legal Information

MILLIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Storage Class

11 - Combustible Solids

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
KW19A04HH304053252461422

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