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KN1HA10TT1

Millipore

Opticap® XL10 Polygard® CN

inlet connection diam. 1.5 in., pore size 10.0 μm, cartridge nominal length 10 in. (25 cm)

Synonym(s):

Opticap XL10 Polygard CN 10.0 μm 1-1/2 in. TC/TC

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About This Item

UNSPSC Code:
23151806
eCl@ss:
32031690

material

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Quality Level

400

reg. compliance

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

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.
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 25 °C
80 psig max. inlet pressure

L

33.5 cm (13.2 in.)

cartridge nominal length

10 in. (25 cm)

diam.

10.7 cm (4.2 in.)

filtration area

0.42 m2

inlet connection diam.

1.5 in.

inlet to outlet W

33.5 cm (13.2 in.)

outlet connection diam.

1.5 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

≤55 mg/capsule

matrix

Polygard®-CN

pore size

10.0 μm nominal pore size
10.0 μm pore size

input

sample type liquid

fitting

inlet sanitary flange
38 mm (1 1/2 in.) inlet/outlet sanitary flange
 outlet sanitary flange

General description

Device Configuration: Capsule

Features and Benefits

Format: Single Layer

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 reduction
  • 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.

Linkage

Replaces: KN1H01TC1

Preparation Note

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable

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 ≥5 L

Legal Information

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

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.

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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