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Aqueous extraction contains ≤0.25 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
3.8 in. (9.7 cm)
Catalogue Number
KGEPG015HH3
Chemistry
Polyethersulfone (PES)
Device Configuration
Capsule
Device Material
Gamma stable polypropylene/Polysulfone
Diameter
5.6 cm (2.2 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
220 cm²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Housing Material
Polypropylene (PP)
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Forward: 6.9 bar (100 psid) intermittent @ 25 °C; 5.5 bar (80 psid) @ 25 °C; 1.0 bar (15 psid) @ 80 °C. Reverse: 2.1 bar (30 psid) @ 25 °C, intermittent
Maximum Inlet Pressure (psig)
80 psig
Maximum Inlet Pressure, bar (psi)
6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
Media
Millipore Express® SHF
Non-Fiber Releasing
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).
Outlet Connection
Hose Barb
Outlet Connection Diameter
9/16 in.
Overview
Sterile capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterility
Gamma
Sterilization
Gamma compatible to 45 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable
Support Material
Polyethylene
Trade Name
Millipore Express®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.25 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
LAGR04TP1
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Size
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 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Material Size
1
Media
Aervent®
Non-Fiber Releasing
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
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
Catalogue Number
MCGB10S02
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polysulfone
Filtration Area
500 cm²
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 sterilized device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Material Package
Easy-Open bag
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)
Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 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)
Sterility
Other
Sterilization
5 SIP cycles of 30 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
Support Material
Polysulfone
Trade Name
Millidisk®
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
Catalogue Number
MCGB10S02
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Cartridge
Device Material
Polysulfone
Filtration Area
500 cm²
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 sterilized device after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Material Package
Easy-Open bag
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)
Forward - 4.1 bar (60 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 123 °C; Reverse - 0.7 bar (10 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)
Sterility
Other
Sterilization
5 SIP cycles of 30 min @ 135 °C; 5 autoclave cycles of 60 min @ 126 °C
Support Material
Polysulfone
Trade Name
Millidisk®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
The MilliporeSigma Patch Test Kit is a complete solution for field-based collection and analysis of hydrocarbon-based hydraulic fluids, bulk chemicals, boiler water, and lubricating oils. It allows the detection of significant changes in cleanliness through dependable, sensitive, colorimetric-based analysis.- Monitors particulate contamination rapidly in hydrocarbon-based hydraulic fluids, bulk chemicals, boiler water and lubricating oils - Filter color rating and particle assessment scales correspond to recognized standard contamination levels - Detects significant changes in cleanliness through dependable and sensitive test results - Comes with filters for 100 tests Features & Benefits:•Contains enough expendable materials for 100 tests •Contained within a lightweight, easy-to-carry case •Filter color rating and particle assessment scales correspond to recognized standard contamination levels Applications:In-Field Contamination Analysis of Hydrocarbon-Based Hydraulic Fluids, Water, Lubricating Oils and Related ProductsKit Catalog Number XX6504730 Patch Test KitComponentsPD1504700 PetriSlides for contamination analysisSMWP02500 MF-Millipore Membrane Filter, 5.0 µm, 25 mm, white, plain, 100SMWP04700 MF-Millipore Membrane Filter, 5.0 µm, 47 mm, white, plain, 100XX6200006P Filter forceps, blunt end, stainless steelXX6200035 Hand Vacuum Pump, stainless steelXX6300120 Patch Test Filter Holder AssemblyXX6504704 Solvent Dispensing BottleXX6504707 Swinnex 25 mm with back-pressure screenXX6504709 PVC Bottle, 120 mLXX6504710 Tubing for vacuum, 1/8 in., fluoroelastomerXX6504713 Naval Fluid Color Guide 1Replacement Parts Clear Sorting & FilteringXX2004701 Funnel Locking RingXX2004703 Gasket, PTFEXX4004714 Locking Ring Gasket, PTFEXX6300123 O-ring, 2-233, Buna-NXX6504708 Stainless Steel Holder Support with base
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Catalogue Number
MPHL06GF2
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Gamma Gold Capsule
Device Material
Polycarbonate
Diameter
3/4 in.
Filtration Area
300 cm²
Flow Rate
10.5 L/min @ 2.45 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 2 mg per sterilized device after a 200 mL flush and 24 hours in water at controlled room temperature.
Inlet Connection
Sanitary Flange
Inlet Connection Diameter
3/4 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
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
3/4 in.
Oxidizable Substances
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥200 mL
Pore Size
0.45 µm
Process Volume
30 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.
Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Catalogue Number
MPHL06GH2
Chemistry
Polyvinylidene Fluoride (PVDF)
Device Configuration
Gamma Gold Capsule
Device Material
Polycarbonate
Diameter
1/4 in.
Filtration Area
300 cm²
Flow Rate
10.5 L/min @ 2.45 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 2 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
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
0.45 µm
Process Volume
30 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.
Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Cartridge Nominal Length
5 in. (12.5 cm)
Catalogue Number
K010A05TT1
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.
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 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
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) @ 23 °C; 2.75 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C
Maximum Inlet Temperature
25 °C
Media
Clarigard®
Nominal Pore Size
1.0 µm
Non-Fiber Releasing
This product was manufactured with a media combination 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
1.0 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 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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