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Merck

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

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806

Key Documents

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Product Name

Opticap® XLT30 Polygard®, inlet connection diam. 1.5 in., pore size 1.2 μm, cartridge nominal length 30 in. (75 cm)

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

Quality Level

400

Related Categories

Analysis Note

Gravimetric Extractables: after 24 hours in water at controlled room temperature

Features and Benefits

Format: Single Layer

General description

Device Configuration: Capsule
T-line/Gauge Port: T-line

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.

Packaging

Double Easy-Open bag

Preparation Note

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

Legal Information

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

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
KN12A3TTT104053252570865

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