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KVEPG006HB3 Millipore

Opticap® XL600 Millipore Express® SHR

sterile; γ-irradiated, inlet connection diam. 9/16 in., pore size 0.1 μm, cartridge nominal length 6.5 in. (16.5 cm)

Synonym: Opticap Gamma Compatible XL 600 Millipore Express SHR single layer 0.1 m 9/16 in. HB/HB with Bell

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Properties

Quality Level   400
material   polyethersulfone
  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)
sterility   sterile; γ-irradiated
feature   hydrophilic
mfr. no.   Millipore Express®
parameter   ≤5.8 mL/min air diffusion at 3.45 bar (50 psig) and 23 °C (in water)
  1.0 bar max. differential pressure (15 psid) at 80 °C (Forward)
  1.0 bar max. inlet pressure (15 psi) at 80 °C
  100 psi max. differential pressure (6.9 bar) (intermittent)
  2.1 bar max. differential pressure (30 psid) at 25 °C (Reverse; intermittent)
  2.75 bar max. inlet pressure (40 psi) at 60 °C
  25 °C max. inlet temp.
  5.5 bar max. differential pressure (80 psid) at 25 °C (Forward)
  5.5 bar max. inlet pressure (80 psi) at 23 °C
  6.9 bar max. differential pressure (100 psid) at 25 °C (Forward; intermittent)
  6.9 bar max. inlet pressure (100 psi) at 23 °C (intermittent)
  80 psi max. differential pressure (5.5 bar) (continuous)
  80 psig max. inlet pressure
L   16.5 cm (6.5 in.)
cartridge nominal length   6.5 in. (16.5 cm)
diam.   5.6 cm (2.2 in.)
filtration area   1010 cm2
inlet connection diam.   9/16 in.
inlet to outlet W   16.5 cm (6.5 in.)
outlet connection diam.   9/16 in.
impurities   ≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
  <0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)
matrix   Millipore Express® SHR
pore size   0.1 μm nominal pore size
  0.1 μm pore size
bubble point   ≥4000 mbar (58 psig), air with water at 23 °C
fitting   1/4 in. drain/vent hose barb (with double O-ring Seal)
  inlet hose barb
  14 mm (9/16 in.) inlet hose barb
  outlet hose barb (with Bell)
  14 mm (9/16 in.) outlet hose barb (with Filling Bell)

Description

General description

Device Configuration: Capsule

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 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.

Preparation Note

Sterilization Method
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable

This product was manufactured with a Millipore Express® 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.

TOC/Conductivity
After sterilization and a controlled water flush of 3.0 L, samples exhibited less than 500 ppb TOC per USP <64>> and less than 1.3 µS/cm per USP <64>> at 25 °C.

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L

Legal Information

ASTM is a registered trademark of American Society for Testing and Materials

MILLIPORE EXPRESS 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.

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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