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KN12A3TTT1

Opticap® XLT30 Polygard®

inlet connection diam. 1.5 in., pore size 1.2 μm, cartridge nominal length 30 in. (75 cm)

Synonym(s):

Opticap XLT 30" Polygard CN 1.2 um 1.5" TC/TC 1/pk, Opticap® XLT30 Polygard®

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806
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Product Name

Opticap® XLT 30 Capsule Media: Polygard®-CN 1.2 µm Nominal, Chemistry: Polypropylene (PP)Inlet: 1-1/2 in. Sanitary FlangeOutlet: 1-1/2 in. Sanitary FlangeT-lineMax Operating Pressure: 80 psi @ 25 °C

Quality Segment

400

material

polypropylene , polypropylene housing, polypropylene support, polypropylene vent cap, silicone seal

reg. compliance

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

manufacturer/tradename

Opticap®

parameter

25 °C max. inlet temp., 80 psig max. inlet pressure

cartridge nominal length

30 in. (75 cm)

inlet connection diam.

1.5 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

≤165 mg/capsule

matrix

Polygard®-CN

pore size

1.2 μm nominal pore size, 1.2 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
T-line/Gauge Port: T-line

Features and Benefits

Format: Single Layer

Packaging

Double Easy-Open bag

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

Other Notes

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.

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

Legal Information

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

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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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