Millipore Express® PHF Capsule Filters
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Overview
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Documentation
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Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® |
Description
Millipore Express® PHF (Process protection, High-Flux) devices provide sterilizing-grade performance, ideal for buffers and other intermediate process fluids. These devices provide broad chemical compatibility, high flow rates and extended throughput for superior process efficiency and economy.
Developed to Enhance Buffer Filtration
Millipore Express® PHF filters use a fast flowing membrane specifically developed for the filtration of buffers, pH adjusters and other aqueous intermediate pharmaceutical and biotech solutions. Designed to offer high-flux performance and improved process economics, Millipore Express® PHF filters are compatible with a wide range of buffer chemistries, including acids and sodium hydroxide.
Filter Applications
- Buffer solutions
- Process additives and intermediates
Benefits
- Sterilizing-grade
- Faster flow rates than most sterilizing-grade filters, reducing process footprint
- Multiple steam-in-place or autoclave sterilization cycles
- Single-use, gamma ready formats
- Broad chemical compatibility, high and low pH 1–14
- Fully scalable product offering
| Opticap® XL and XLT Disposable Capules (Autoclavable) | ||||||
| XL 3 | XL 5 | XL 10 | XLT 10 | XLT 20 | XLT 30 | |
| Nominal Dimensions | ||||||
| Maximum Length | 17.3 cm (6.8 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | 37.6 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body Diameter | 10.7 cm (4.2 in.) | - | ||||
| Fitting to Fitting | ||||||
| Sanitary Flange to Sanitary Flange | - | 15.2 cm (6.0 in.) | ||||
| Sanitary Flange to Hose Bard | - | 17.5 cm (6.9 in.) | ||||
| Hose Barb to Hose Barb | - | 19.8 cm (7.8 in.) | ||||
| Filtration Area | 0.17 m² (1.8 ft²) | 0.31 m² (3.3 ft²) | 0.57 m² (6.1 ft²) | 1.14 m² (12.3 ft²) | 1.71 m² (18.4 ft²) | |
| Materials of Construction | ||||||
| Filter Membrane | Hydrophilic Polyethersulfone (PES) | |||||
| Film Edge | Polypropylene | |||||
| Supports | Polypropylene | |||||
| Structual Components* | Polypropylene | |||||
| Core | Polysulfone | |||||
| Vent O-rings | Silicone | |||||
| Vent/Darin | ¼ in. hose barb with double O-ring seal | |||||
| Maximum Differential Pressure | ||||||
| Forward | 5.5 (80) @ 25 °C | |||||
| Reverse | - | |||||
| Air Diffusions at 23°C | ≤9.1 mL/min @ 2.8 bar (40 psig) in water | ≤16.4 mL/min @ 2.8 bar (40 psig) in water | ≤30 mL/min @ 2.8 bar (40 psig) in water | ≤60 mL/min @ 2.8 bar (40 psig) in water | ≤90 mL/min @ 2.8 bar (40 psig) in water | |
| Bacterial Retention | Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. | |||||
| Bacterial Endotoxin | A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | |||||
| TOC/Conductivity | After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>. | |||||
| Oxidizable Subtances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1.5 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L | ||
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C. (Cannot be steam sterilized in-line). | |||||
| USP Toxicity | Non-toxic per USP Cytotoxicity MEM Elusion Test. | |||||
| Particle Shedding | Passes USP test for particulates in injectables. | |||||
| 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). | |||||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. | |||||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |||||
| Good Manufacturing Practice | This product was manufactured in a facility which adheres to Good Manufacturing Practices. | |||||
| *Cage, end caps and capsule housing | ||||||
| Opticap® XL 150, 300 and 600 Disposable Capsules (Sterile and Gamma Compatible) | |||
| XL 150 | XL 300 | XL 600 | |
| Nominal Dimensions | |||
| Maximum Length | 9.7 cm (3.8 in.) | 11.9 cm (4.7 in.) | 16.5 cm (6.5 in.) |
| Body Diameter | 5.6 cm (2.2 in.) | ||
| Fitting to Fitting | |||
| Sanitary Flange to Sanitary Flange | - | ||
| Sanitary Flange to Hose Bard | - | ||
| Hose Barb to Hose Barb | - | ||
| Filtration Area | 0.022 m² (0.240 ft²) | 0.048 m² (0.514 ft²) | 0.097 m² (1.046 ft²) |
| Materials of Construction | |||
| Filter Membrane | Hydrophilic Polyethersulfone (PES) | ||
| Film Edge | - | ||
| Supports | Polyethylene | ||
| Structual Components* | Gamma stable polypropylene | ||
| Core | Polysulfone | ||
| Vent O-rings | Silicone | ||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | ||
| Maximum Differential Pressure | |||
| Forward | 5.5 (80) @ 25 °C | ||
| Reverse | - | ||
| Air Diffusions at 23°C | ≤1.4 mL/min @ 2.8 bar (40 psig) in water | ≤2.8 mL/min @ 2.8 bar (40 psig) in water | ≤5.8 mL/min @ 2.8 bar (40 psig) in water |
| Bacterial Retention | Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. | ||
| Bacterial Endotoxin | A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | ||
| TOC/Conductivity | After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>. | ||
| Oxidizable Subtances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L | ||
| Sterilization | |||
| Gamma compatible: | Gamma compatible to 40 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable | ||
| Sterile capsules: | 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable | ||
| USP Toxicity | Non-toxic per USP Cytotoxicity MEM Elusion Test. | ||
| Particle Shedding | Passes USP test for particulates in injectables. | ||
| 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). | ||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practice | This product was manufactured in a facility which adheres to Good Manufacturing Practices. | ||
| *Cage, end caps and capsule housing Note: Filters were tested post gamma radiation at 25-40 kGy |
|||
| Opticap® XL and XLT Disposable Capsules (Sterile and Gamma Compatible) | ||||||
| XL 3 | XL 5 | XL 10 | XLT 10 | XLT 20 | XLT 30 | |
| Nominal Dimensions | ||||||
| Maximum Length | 17.3 cm (6.8 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | 37.6 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body Diameter | 10.7 cm (4.2 in.) | - | ||||
| Fitting to Fitting | ||||||
| Sanitary Flange to Sanitary Flange | - | 15.2 cm (6.0 in.) | ||||
| Sanitary Flange to Hose Bard | - | 17.5 cm (6.9 in.) | ||||
| Hose Barb to Hose Barb | - | 19.8 cm (7.8 in.) | ||||
| Filtration Area | 0.17 m² (1.8 ft²) | 0.31 m² (3.3 ft²) | 0.57 m² (6.1 ft²) | 1.14 m² (12.3 ft²) | 1.71 m² (18.4 ft²) | |
| Materials of Construction | ||||||
| Filter Membrane | Hydrophilic Polyethersulfone (PES) | |||||
| Film Edge | Polyethylene | |||||
| Supports | Polyester | |||||
| Structual Components* | Gamma stable polypropylene | |||||
| Core: | Polysulfone | |||||
| Vent O-rings: | Silicone | |||||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | |||||
| Maximum Differential Pressure | ||||||
| Forward | 5.5 (80) @ 25 °C | |||||
| Reverse | - | |||||
| Air Diffusions at 23°C | ≤9.5 mL/min @ 2.8 bar (40 psig) in water | ≤17.4 mL/min @ 2.8 bar (40 psig) in water | ≤32.7 mL/min @ 2.8 bar (40 psig) in water | ≤65.5 mL/min @ 2.8 bar (40 psig) in water | ≤98.2 mL/min @ 2.8 bar (40 psig) in water | |
| Bacterial Retention | Samples of membrane used in this filter were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology. | |||||
| Bacterial Endotoxin | A sample aqueous extraction contains less than 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test. | |||||
| TOC/Conductivity | After sterilization and a controlled water flush of 15 mL, samples exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µS/cm per USP <645>. | |||||
| Oxidizable Subtances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1.5 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥3 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4.5 L | ||
| Sterilization | ||||||
| Gamma compatible: | Gamma compatible to 40 kGy; 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable | |||||
| Sterile capsules: | 3 autoclave cycles of 60 min @ 123 °C; not in-line steam sterilizable | |||||
| USP Toxicity | Non-toxic per USP Cytotoxicity MEM Elusion Test. | |||||
| Particle Shedding | Passes USP test for particulates in injectables. | |||||
| 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). | |||||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. | |||||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | |||||
| Good Manufacturing Practice | This product was manufactured in a facility which adheres to Good Manufacturing Practices. | |||||
| *Cage, end caps and capsule housing Note: Filters were tested post gamma radiation at 25-40 kGy |
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