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Merck
CN

KTGRA02TH3

Aervent® 0.2 µm, Opticap® XL Capsule

inlet connection diam. 1.5 in., Opticap® XL 2, pore size 0.2 μm, cartridge nominal length 2 in. (5 cm)

Synonym(s):

Opticap XL 2 with Aervent - 2" 0.2um TC/HB 3pk

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About This Item

eCl@ss:
32031690
UNSPSC Code:
23151806

Key Documents

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parameter

80 psig max. inlet pressure, 1.0 bar max. differential pressure (15 psid) at 80 °C (Forward), 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., 4.1 bar max. differential pressure (60 psid) at 25 °C (Reverse; intermittent), 5.5 bar max. differential pressure (80 psid) at 25 °C (Forward), 5.5 bar max. inlet pressure (80 psi) at 25 °C

material

PTFE , polypropylene , polypropylene housing, polypropylene vent cap, silicone seal

sterility

non-sterile

sterilization compatibility

autoclavable compatible

product line

Opticap® XL 2

feature

hydrophobic

manufacturer/tradename

Opticap®

technique(s)

gas filtration: suitable

L

5.6 in.

W

3.3 in.

cartridge nominal length

2 in. (5 cm)

diam.

8.4 cm (3.3 in.)

filtration area

0.1 m2

inlet connection diam.

1.5 in.

outlet connection diam.

9/16 in.

impurities

<0.5 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

gravimetric extractables

≤15 mg

matrix

Aervent®

pore size

0.2 μm pore size

fitting

1/4 in. drain/vent hose barb (with double O-ring Seal), (38 mm (1 1/2 in.) Sanitary Flange Inlet and 14 mm (9/16 in.) Hose Barb Outlet)

Quality Level

400

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General description

Device Configuration: Capsule

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Analysis Note

Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Gravimetric Extractables: after 24 hours in a 70/30% IPA/water mixture at controlled room temperature

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 Steam Sterilization & Integrity Testing Procedures guide and first page of Visual Inspection 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

AERVENT is a registered trademark of Merck KGaA, Darmstadt, Germany
ASTM is a registered trademark of American Society for Testing and Materials
OPTICAP 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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