KPHLS10FF1 - Merck - Filters and Filtration - Chromatography - Lab supplies

: Catalog No. KPHLS10FF1

Part No. KPHLS10FF1
Supplier Merck KGaA

Opticap® Sterile XL10 Durapore® 0.45 µm FS/FS

Net Price

401

Availability

4 weeks

PROPERTIES

Bacterial Endotoxins

Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Nominal Length

13.2 in. (33.5 cm)
Catalogue Number

KPHLS10FF1
Chemistry

Polyvinylidene Fluoride (PVDF)
Device Configuration

Capsule
Device Material

Polypropylene
Device Size

10 in.
Diameter

10.7 cm (4.2 in.)
Filtration Area

0.62 m²
Good Manufacturing Practices

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Gravimetric Extractables

The extractables level was equal to or less than 25 mg per capsule after 24 hours in water at controlled room temperature.
Housing Material

Polypropylene (PP)
Indirect Food Additive

All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Inlet Connection

Sanitary Flange
Inlet Connection Diameter

3/4 in.
Inlet to Outlet Width

33.5 cm (13.2 in.)
Length

13.2 in. (33.5 cm)
Material Size

1
Maximum Differential Pressure, bar (psid)

Forward: 4.1 bar (60 psid) @25 ˚C. Reverse: 2.1 bar (30 psid) @ 4-40 °C
Maximum Inlet Pressure (psig)

80 psig
Maximum Inlet Pressure, bar (psi)

5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature

25 °C
Media

Durapore®
Outlet Connection

Sanitary Flange
Outlet Connection Diameter

3/4 in.
Oxidizable Substances

Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1500 mL
Pore Size

0.45 µm
Seal Material

Lead O-ring: Silicone-coated EPDM, Outer O-ring: Silicone
Sterility

Sterile
Sterilization

Gamma compatible to 40 kGy. 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Support Material

Polyester/Polyethylene
Trade Name

Opticap®
USP Bacterial Endotoxins

A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Vent Cap Material

Polypropylene (PP)
Wettability

Hydrophilic
Width

33.5 cm (13.2 in.)

DESCRIPTION

Prefiltration / Bioburden reduction in single use assemblies Bioburden reduction before final sterilization Process protection of intermediate consumables esp. in Plasma / Vaccine / r-Protein