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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.
Catalogue Number
MPGL04GH2
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Gamma Gold Capsule
Device Material
Polycarbonate
Diameter
1/4 in.
Filtration Area
200 cm²
Flow Rate
2.8 L/min @ 1.75 bar ΔP
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 1.5 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
Inlet Connection
Hose Barb
Inlet Connection Diameter
1/4 in.
Material Package
Blister
Material Size
2
Maximum Differential Pressure, bar (psid)
Forward: 4.1 bar (60 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 123 °C; Reverse: 0.7 bar (10 psid) @ 25 °C
Maximum Inlet Pressure, bar (psi)
5.2 bar (75 psi) @ 25 °C
Maximum Operating 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
Hose Barb with Bell
Outlet Connection Diameter
1/4 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Pore Size
0.22 µm
Process Volume
20 L
Sterility
Sterile
Sterilization
3 autoclave cycles of 90 min @ 123 °C; not in-line steam sterilizable
Support Material
Polycarbonate
Trade Name
Millipak®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
A sample aqueous extraction contains less than 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.
Catalogue Number
MPGL10CB1
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Capsule
Diameter
1/4 in.
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 2.5 mg per device after 24 hours in water at controlled room temperature.
Inlet Connection
NPT
Inlet Connection Diameter
1/4 in.
Length
13 cm (5.12in.)
Material Size
1
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
NPT
Outlet Connection Diameter
1/4 in.
Pore Size
0.22 µm
Sterility
Other
Sterilization
3 autoclave cycles of 90 min @ 123°C; not in-line steam sterilizable
Trade Name
Millipak®
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 Nominal Length
5 in. (12.5 cm)
Catalogue Number
KRK1A05FF1
Chemistry
Polypropylene (PP)
Device Configuration
Capsule
Device Material
Polypropylene
Device Size
5 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.
Format
Single Layer
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 30 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
21.6 cm (8.5 in.)
Length
5 in. (12.5 cm)
Material Package
Double Easy-Open bag
Material Size
1
Maximum Differential Pressure, bar (psid)
4.8 bar (70 psid) @ 20 °C
Maximum Inlet Pressure (psig)
80 psig
Maximum Inlet Pressure, bar (psi)
5.5 bar (80 psi) @ 25 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
Media
Polygard®-CR
Nominal Pore Size
0.1 µm
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 ≥2.5 L
Pore Size
0.1 µm
Seal Material
Silicone (SI)
Sterilization
3 autoclave cycles of 30 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.
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