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Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Cartridge Nominal Length
20 in. (50 cm)
Catalogue Number
KVGLA2FTT1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
20 in.
Diameter
10.7 cm (4.2 in.)
European Pressure Equipment Directive
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.
Filtration Area
1.4 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 50 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
1-1/2 in.
Inlet to Outlet Width
19.8 cm (7.8 in.)
Length
20 in. (50 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 3.4 bar (50 psid) @ 25 °C, intermittent
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®
Non-Fiber Releasing
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).
Outlet Connection
Sanitary Flange
Outlet Connection Diameter
1-1/2 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L
Pore Size
0.22 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable
Support Material
Polypropylene
Trade Name
Opticap®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Trust Merck membrane filtration devices for the collection and preparation of samples, mobile phases, and buffers to obtain the highest quality results from downstream analysis.
Whether you need to collect, separate, or remove contaminants from air or fluid samples prior to downstream analysis, our broad selection of syringe filters, membranes, filter holders and related filtration devices ensures that we have the right solution for your application.
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