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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 Code
Not Applicable
Cartridge Nominal Length
4 in. (10 cm)
Catalogue Number
LAGB04TP6
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
4 in.
Filtration Area
0.18 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 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Length
4 in. (10 cm)
Material Package
Double Easy-Open bag
Material Size
6
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 3.5 bar (50 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C KEEP
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 3.5 bar (50 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 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).
Pore Size
0.22 µm
Seal Material
Silicone (SI)
Sterilization
30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °C
Support Material
Polypropylene
Trade Name
Optiseal®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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 Code
Not Applicable
Cartridge Nominal Length
4 in. (10 cm)
Catalogue Number
LAGB04TP6
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
4 in.
Filtration Area
0.18 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 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Length
4 in. (10 cm)
Material Package
Double Easy-Open bag
Material Size
6
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 3.5 bar (50 psid) @ 80 °C; 0.35 bar (5 psid) @ 121 °C. Reverse: 3.5 bar (50 psid) @ 25 °C KEEP
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 3.5 bar (50 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 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).
Pore Size
0.22 µm
Seal Material
Silicone (SI)
Sterilization
30 SIP cycles of 30 min @ 135 °C; 10 autoclave cycles of 30 min @ 126 °C
Support Material
Polypropylene
Trade Name
Optiseal®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 5 (2-222) O-rings and spear
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVHL51PP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.69 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 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 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).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
0.45 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
Support Material
Polypropylene
Trade Name
Durapore®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Code
Code 5 (2-222) O-rings and spear
Cartridge Nominal Length
10 in. (25 cm)
Catalogue Number
CVHL51PP3
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
10 in.
Diameter
6.9 cm (2.7 in.)
Filtration Area
0.69 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 20 mg per 10-inch cartridge after 24 hours in water at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. All component materials meet the requirements of the EU framework regulation [1935/2004/EC] regarding materials and articles intended to contact food.
Length
10 in. (25 cm)
Material Package
Double Easy-Open bag
Material Size
3
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 3.5 bar (50 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 3.5 bar (50 psi) @ 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).
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
0.45 µm
Seal Material
Silicone (SI)
Sterility
Other
Sterilization
30 SIP cycles of 30 min @ 135 °C; 30 autoclave cycles of 60 min @ 126 °C
Support Material
Polypropylene
Trade Name
Durapore®
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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