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Merck

KVGLG2TTT1

Millipore

Durapore® 0.22 µm, Opticap® XLT Capsule

inlet connection diam. 1.5 in., Opticap® XLT 20, cartridge nominal length 20 in. (50 cm)

Synonym(s):

Opticap Gamma Compatible XLT20 Durapore 0.22 μm 1-1/2 in. TC

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About This Item

UNSPSC Code:
23151806

Pricing and availability is not currently available.

material

PVDF
polyester support
polyethylene support
polypropylene (gamma-stable)
polypropylene housing
polypropylene vent cap
silicone seal

Quality Level

reg. compliance

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

sterility

non-sterile

Sterilization Compatibility

gamma compatible

product line

Opticap® XLT 20

feature

gamma compatible
hydrophilic

manufacturer/tradename

Opticap®

parameter

≤28 mL/min air diffusion at 2.75 bar (40 psig) and 23 °C (in water)
1.0 bar max. inlet pressure (15 psi) at 80 °C
1.7 bar max. differential pressure (25 psid) at 80 °C (Forward)
2.8 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 (Reverse; intermittent)
5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

technique(s)

sterile filtration: suitable

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General description

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

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
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer Wetting Instructions for Filter Units with Durapore® Membrane user guide
  • Storage Statement: Store in dry location
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Preparation Note

Sterilization Method
3 autoclave cycles of 60 min @ 126 °C; capable of 45 kilogray (4.5 Megarad) gamma exposure; not in-line steam sterilizable
This product was manufactured with a Durapore® 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 water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Legal Information

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

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