MilliporeSigma
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KVEPG1TBB1

Millipore

Opticap® Gamma Compatible XLT Capsule Filter

cartridge nominal length 10 in. (25 cm), filter diam. 10.7 cm (4.2 in.)

material

polyester support
polypropylene device
polypropylene housing
polypropylene vent cap
silicone seal

Quality Level

reg. compliance

meets FDA 21 CFR 177-182 (all component materials)

sterility

irradiated
non-sterile

product line

Opticap® XLT

feature

hydrophilic

manufacturer/tradename

Millipore Express®

parameter

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

technique(s)

sterile filtration: suitable

W

7.8 in.

cartridge nominal length

10 in. (25 cm)

device L

37.7 cm (14.8 in.)

device size

10 in.

filter diam.

10.7 cm (4.2 in.)

filter filtration area

0.69 m2

impurities

≤0.25 EU/mL bacterial endotoxins (LAL test, aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (sample aqueous extraction)

matrix

Millipore Express® SHR

pore size

0.1 μm pore size

bubble point

≥2586 mbar (37.5 psig), nitrogen with 70/30% IPA/water

fitting

(25 mm (1 in.) Hose Barb Inlet and Outlet)

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This Item
KHGEG2THH1KVEPG1TTH1KGEPG2THH1
material

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

material

polyester support, polypropylene device, polypropylene housing, polypropylene vent cap, polysulfone device, silicone seal

material

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

material

polyester support, polypropylene device (gamma stable), polypropylene housing, polypropylene vent cap, polysulfone device, silicone seal

sterility

irradiated, non-sterile

sterility

irradiated, non-sterile

sterility

irradiated, non-sterile

sterility

irradiated, non-sterile

product line

Opticap® XLT

product line

Opticap® XLT

product line

Opticap® XLT

product line

Opticap® XLT

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

feature

hydrophilic

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

technique(s)

sterile filtration: suitable

matrix

Millipore Express® SHR

matrix

Millipore Express® SHC

matrix

Millipore Express® SHR

matrix

Millipore Express® SHF

General description

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

Packaging

Double Easy-Open bag

Preparation Note

Sterilization Method:
Gamma Compatible to 45 kGy. May be autoclaved for 3 cycles of 60 min at 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 11 L, samples exhibited &#x3C 500 ppb TOC per USP &#x3C 643 &#x3C and &#x3C 1.3 μS/cm per USP &#x3C 645 &#x3C at 25 °C.
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1.5 L

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 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

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

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