Millipore Express® SHR Opticap® Capsule Filters
Millipore Express® SHR (Sterile High-retention) devices provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions.
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Millipore Express® SHR (Sterile High-retention) devices provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions. Menos
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| Opticap® |
Categorías
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHR |
Description
- High-flux hydrophilic sterilizing-grade 0.1 µm rated PES membrane for improved process economy
- Designed for sterilizing grade performance and mycoplasma removal
- On-board PES membrane prefilter for extended throughput in high fouling media
- Robust construction which will withstand multiple sterilization cycles
- Easy wetting and integrity testing
- Broad chemical compatibility across a wide pH range (pH 1–14)
Millipore Express® SHR (Sterile High-Retention) Opticap® capsules provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions including: cell culture media, media additives, process intermediates, and other biological fluids. Millipore Express® SHR Opticap capsules provide high sterility assurance, broad chemical compatibility, high flow rates and extended throughput for superior process efficiency and economy.
Sterilizing-grade Millipore Express®SHR capsule filters are available with an on-board polyethersulfone membrane prefilter which protects the sterilizing grade 0.1 µm rated membrane from premature plugging for enhanced throughput in high fouling streams. These high-retention filters are recommended for the removal of mycoplasma and other small microorganisms that can pass through a 0.2 µm rated sterilizing-grade filter.
Filter Applications
- Cell culture media
- Media additives
- Serum
- Concentrated protein
- Process intermediates
- Biologicals
Sterilizing-grade Millipore Express® SHR for Bacterial Retention and Mycoplasma Removal
Sterilizing-grade Millipore Express SHR for Bacterial Retention and Mycoplasma Removal
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Enhanced Sterility Assurance
Millipore Express® SHR sterilizing-grade devices are designed for the removal of mycoplasma and small microorganisms that can pass through a 0.2 µm rated sterilizing grade filter. Millipore Express® SHR filters have demonstrated high mycoplasma removal – typical Log Reduction Value (LRV) ≥ 7 using Acholeplasma laidlawii ATCC® 23206 and Millipore's standardized test method.
Permeability/10-inch* and Typical LRV
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*Tested in duplicate at 10 psi on 47 mm disc and scaled to 10-inch
Superior Process Efficiency/Economy
Millipore Express® SHR filters provide high flow rates, broad chemical compatibility (pH 1–14) and extended capacity for lower filtration costs. You get fast flowing, caustic stable filters which provide enhanced sterility assurance and high performance with cell culture media, sera and other high fouling biological process solutions.
Reduce Surface Area and Lower Your Costs
The on-board polyethersulfone membrane prefilter protects the sterilizing grade membrane from premature plugging and extends filter capacity in highly fouling streams, so you can maintain batch volume while reducing filtration surface area requirements.
NS0 Serum-free, Protein-free, Cell Culture Media
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CHO Serum-free Cell Culture Media
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Reliable Performance
Millipore Express® SHR filters deliver:
- Enhanced sterility assurance: Validated sterilizing-grade filtration and reliable mycoplasma removal
- High flow rates for improved process efficiency
- Superior process economy: On-board PES membrane prefilter extends filter capacity and reduces filtration area requirements
Superior Filter Robustness
- Multiple steam-in-place or autoclave sterilization cycles
- Broad chemical compatibility
- Easy filter wetting and integrity testing
Multiple Formats Available
Opticap®XL 150, 300, and 600 capsule filters with Millipore Express® membranes are ideal for small volume sterile filling applications and process development work. An optional filling bell can be used to reduce contamination risk when transferring sterile media from large containers to media bottles or culture vessels.
Opticap® XL 3, 5, and 10 capsule filters have a unique design to minimize hold-up volume and reduce production losses.
Opticap® XLT 10, 20, and 30 T-line capsule filters design accomodates series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap® XLT filter into your existing process.
All of these formats are available as gamma-compatible or sterile devices. Opticap® XL 3 and larger capsules are also available as autoclavable devices.
Autoclavable Capsules
| Opticap® XL and XLT Disposable Capsules ( Autoclavable Only) Millipore Express® SHR 0.1 µm Membrane |
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| Opticap® XL 3 Capsules | Opticap® XL 5 Capsules | Opticap® XL 10 Capsules | |
| Nominal Dimensions | |||
| Maximum Length | 17.3 cm (6.8 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) |
| Body Diameter | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) |
| Filtration Area | 0.16 m2 (1.7 ft2) | 0.29 m2 (3.1 ft2) | 0.60 m2 (6.5 ft2) |
| Materials of Construction | |||
| Filter Membrane | Hydrophilic polyethersulfone | ||
| Film edge | Polypropylene | ||
| Supports | Polypropylene | ||
| Core | Polysulfone | ||
| Structural components* | Polypropylene | ||
| Vent O-rings | Silicone | ||
| Vent Drain | 6 mm ( 1/4 in.) hose barb with double O-ring seal | ||
| Maximum Inlet Pressure | 6900 mbar (100 psi) intermittent at 23° C 5500 mbar (80 psi) at 23° C 2800 mbar (40 psi) at 60° C 1000 mbar (15 psi) at 80° C |
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| Maximum Differential Pressure | |||
| Forward | 6900 mbar (100 psi) intermittent at 25° C 5500 mbar (80 psi) at 25° C 1000 mbar (15 psi) at 80° C |
||
| Reverse | 2100 mbar (30 psi) intermittent at 25° C | ||
| 70/30 IPA Bubble Point at 23° C | ≥2590 mbar (37.5 psi) with nitrogen | ||
| Air Diffusion at 23° C | Through a water wet membrane at 3.4 bar (50 psi): | ||
| ≤8.7 cc/min. | ≤15.9 cc/min. | ≤33.3 cc/min. | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC° 19146 per ASTM° methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC® 23206 and our validated test method. | ||
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| TOC/Conductivity | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 3 L | 5.5 L | 10 L | |
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a WFI flush of: | ||
| 1000 mL | 1000 mL | 1000 mL | |
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 123° C. ( Cannot be steam sterilized in-line.) | ||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express® SHR filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5. | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-fiber Releasing | Millipore Express® SHR membranes meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Opticap® XL and XLT Disposable Capsules ( Autoclavable Only) Millipore Express® SHR 0.1 µm Membrane |
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| Opticap® XLT 10 Capsules | Opticap® XLT 20 Capsules | Opticap® XLT 30 Capsules | |
| Nominal Dimensions | |||
| Maximum Length | 38.1 cm (15.0 in.) | 62.5 cm (24.6 in.) | 87.1 cm (34.3 in.) |
| Body Diameter | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) |
| Filtration Area | 0.60 m2 (6.5 ft2) | 1.21 m2 (13.0 ft2) | 1.81 m2 (19.5 ft2) |
| Materials of Construction | |||
| Filter Membrane | Hydrophilic polyethersulfone | ||
| Film edge | Polypropylene | ||
| Supports | Polypropylene | ||
| Core | Polysulfone | ||
| Structural components* | Polypropylene | ||
| Vent O-rings | Silicone | ||
| Vent Drain | 6 mm ( 1/4 in.) hose barb with double O-ring seal | ||
| Maximum Inlet Pressure | 6900 mbar (100 psi) intermittent at 23° C 5500 mbar (80 psi) at 23° C 2800 mbar (40 psi) at 60° C 1000 mbar (15 psi) at 80° C |
||
| Maximum Differential Pressure | |||
| Forward | 6900 mbar (100 psi) intermittent at 25° C 5500 mbar (80 psi) at 25° C 1000 mbar (15 psi) at 80° C |
||
| Reverse | 2100 mbar (30 psi) intermittent at 25° C | ||
| 70/30 IPA Bubble Point at 23° C | ≥2590 mbar (37.5 psi) with nitrogen | ||
| Air Diffusion at 23° C | Through a water wet membrane at 3.4 bar (50 psi): | ||
| ≤33.3 cc/min. | ≤66.6 cc/min. | ≤99.9 cc/min. | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC° 19146 per ASTM° methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC® 23206 and our validated test method. | ||
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| TOC/Conductivity | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 10 L | 20 L | 30 L | |
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a WFI flush of: | ||
| 1000 mL | 2000 mL | 3000 mL | |
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 123° C. ( Cannot be steam sterilized in-line.) | ||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express® SHR filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5. | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-fiber Releasing | Millipore Express® SHR membranes meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Opticap® XL and XLT Disposable Capsules (Autoclavable Only) Millipore Express® SHR 0.5/0.1 µm Membrane with Prefilter |
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| Opticap® XL 3 | Opticap® XL 5 | Opticap® XL 10 | |
| Filtration Area | 0.13 m² | 0.23 m² | 0.49 m² |
| Materials of Construction | |||
| Filter Membrane | Polyethersulfone (PES) | Polyethersulfone (PES) | Polyethersulfone (PES) |
| Film Edge | Polypropylene | Polypropylene | Polypropylene |
| Supports | Polypropylene | Polypropylene | Polypropylene |
| Structural Components/Core | Polypropylene/Polysulfone | Polypropylene/Polysulfone | Polypropylene/Polysulfone |
| Vent O-rings | Silicone (SI) | Silicone (SI) | Silicone (SI) |
| Vent/Drain | 1/4 in. hose barb with double silicone O-ring seal | ||
| Maximum Inlet Pressure, bar (psid) | 6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C | ||
| Maximum Differential Pressure, bar (psid) | |||
| 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 | ||
| Bubble Point at 23 °C | ≥ 2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water | ||
| Air Diffusion at 23 °C | ≤7.2 mL/min @ 3.45 bar (50 psig) in water | ≤12.8 mL/min @ 3.45 bar (50 psig) in water | ≤27.1 mL/min @ 3.45 bar (50 psig) in water |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method | ||
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||
| TOC/Conductivity at 25◦ C | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 5.5 liters | 9.5 liters | 20 liters | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L |
| Sterilization | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable | ||
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| USP Toxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Opticap® XLT 10 | Opticap® XLT 20 | Opticap® XLT 30 | |
| Filtration Area | 0.49 m² | 0.98 m² | 1.48 m² |
| Materials of Construction | |||
| Filter Membrane | Polyethersulfone (PES) | Polyethersulfone (PES) | Polyethersulfone (PES) |
| Film Edge | Polypropylene | Polypropylene | Polypropylene |
| Supports | Polypropylene | Polypropylene | Polypropylene |
| Structural Components/Core | Polypropylene/Polysulfone | Polypropylene/Polysulfone | Polypropylene/Polysulfone |
| Vent O-rings | Silicone (SI) | Silicone (SI) | Silicone (SI) |
| Vent/Drain | 1/4 in. hose barb with double silicone O-ring seal | ||
| Maximum Inlet Pressure, bar (psid) | 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 Differential Pressure, bar (psid) | 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 | ||
| Bubble Point at 23 °C | ≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water | ||
| Air Diffusion at 23 °C | ≤27.1 mL/min @ 3.45 bar (50 psig) in water | ≤54.2 mL/min @ 3.45 bar (50 psig) in water | ≤81.3 mL/min @ 3.45 bar (50 psig) in water |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method | ||
| Bacterial Endotoxins | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||
| TOC/Conductivity at 25◦C | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 20 liters | 40 liters | 60 liters | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥4 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥6 L |
| Sterilization | 3 autoclave cycles of 60 min @ 126 °C; not in-line steam sterilizable | ||
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the criteria set forth in USP <788> for large volume parenterals. | ||
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
Typical Clean Water Flow Rate vs Pressure Drop (Autoclavable Capsules)
Opticap® XL 3 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XL 5 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XL 10 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XLT 10 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XLT 20 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XLT 30 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Sterile and Gamma Compatible Capsules
Millipore Express® SHR 0.1 μm Membrane
| Opticap® XL 150 | Opticap® XL 300 | Opticap® XL 600 | |
| Filtration Area | 0.025m2 | 0.048m2 | 0.101m2 |
| Materials of Construction | |||
| Filter Membrane | Polyethylene | ||
| Supports | Polyester | Polyester | Polyester |
| Structural Components/Core | Gamma stable polypropylene/Polysulfone | Gamma stable polypropylene/Polysulfone | Gamma stable polypropylene/Polysulfone |
| Vent O-rings | Silicone | Silicone | Silicone |
| Maximum Inlet Pressure, bar (psid) | 6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C | ||
| Maximum Differential Pressure, bar (psid) | 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 | ||
| Bubble Point at 23 °C | ≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water | ||
| Air Diffusion at 23 °C | ≤ 1.4 cc/min @3.45 bar (50 psig) in water | ≤ 1.4 cc/min @3.45 bar (50 psig) in water | ≤ 5.8 cc/min @ 3.45 bar (50 psig) in water |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) ≥ 7 using A. laidlawii ATCC 23206 and Millipore's standard test method | ||
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||
| TOC/Conductivity | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 2 liters | 2.5 liters | 3 liters | |
| Oxidizable Substances | 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 L | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥1 L |
| Sterilization | |||
| Gamma compatible capsules | Gamma compatible to 45 kGy: may be autoclaved for 3 cycles of 60 minutes at 123° C (Cannot be steam sterilized in-line) | ||
| Sterile capsules | May be autoclaved for 3 cycles of 60 minutes at 123° C (Cannot be steam sterilized in-line) | ||
| Sterility | |||
| Sterile capsules | These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | ||
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Opticap® XL3 | Opticap® XL5 | Opticap® XL10 | |
| Filtration Area | 0.17 m2 | 0.31 m2 | 0.69 m2 |
| Materials of Construction | |||
| Filter Membrane | Polyethersulfone (PES) | Polyethersulfone (PES) | Polyethersulfone (PES) |
| Film Edge | Polypropylene | Polypropylene | Polypropylene |
| Supports | Polyester | Polyester | Polyester |
| Structural Components/Core | Gamma stable polypropylene/Polysulfone | Gamma stable polypropylene/Polysulfone | Gamma stable polypropylene/Polysulfone |
| Vent O-rings | Silicone (SI) | Silicone (SI) | Silicone (SI) |
| Vent/Drain | 1/4 in. hose barb with double silicone O-ring seal | ||
| Maximum Inlet Pressure, bar (psid) | 6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C | ||
| Maximum Differential Pressure, bar (psid) | 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 | ||
| Bubble Point at 23 °C | ≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water | ||
| Air Diffusion at 23 °C | ≤ 9.4 cc/min @3.45 bar ( 50 psig) in water | ≤ 17.3 cc/min @3.45 bar ( 50 psig) in water | ≤ 38.8 cc/min @3.45 bar ( 50 psig) in water |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method | ||
| Bacterial Endotoxins | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||
| TOC/Conductivity | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 3.5 liters | 6.0 liters | 11 liters | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 liter | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 liter | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1 liter |
| Sterilization | |||
| Gamma compatible | Gamma compatible to 45 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 | ||
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Opticap® XLT 10 | Opticap® XLT 20 | Opticap® XLT 30 | |
| Filtration Area | 0.69 m2 | 1.38 m2 | 2.06 m2 |
| Materials of Construction | |||
| Filter Membrane | Polyethersulfone (PES) | Polyethersulfone (PES) | Polyethersulfone (PES) |
| Film Edge | Polypropylene | Polypropylene | Polypropylene |
| Supports | Polyester | Polyester | Polyester |
| Structural Components/Core | Gamma stable polypropylene/Polysulfone | Gamma stable polypropylene/Polysulfone | Gamma stable polypropylene/Polysulfone |
| Vent O-rings | Silicone (SI) | Silicone (SI) | Silicone (SI) |
| Vent/Drain | 1/4 in. hose barb with double silicone O-ring seal | ||
| Maximum Inlet Pressure, bar (psid) | 6.9 bar (100 psi) intermittent @ 23 °C; 5.5 bar (80 psi) @ 23 °C; 2.8 bar (40 psi) @ 60 °C; 1.0 bar (15 psi) @ 80 °C | ||
| Maximum Differential Pressure, bar (psid) | 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 | ||
| Bubble Point at 23 °C | ≥2590 mbar (37.5 psig) nitrogen with 70/30 % IPA/water | ||
| Air Diffusion at 23 °C | ≤ 38.8 cc/min @ 3.45 bar (50 psig) in water | ≤ 77.6 cc/min @ 3.45 bar (50 psig) in water | ≤ 116.4 cc/min @ 3.45 bar (50 psig) in water |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) > 7 using A. laidlawii ATCC 23206 and Millipore's standard test method | ||
| Bacterial Endotoxins | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | ||
| TOC/Conductivity at 25◦ C | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 11 liters | 22 liters | 33 liters | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 1.5 liters | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 3 liters |
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥ 4.5 liters |
| Sterilization | |||
| Gamma compatible | Gamma compatible to 45 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 | ||
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-Fiber Releasing | Component materials meet the "non-fiber releasing" criteria as defined in 21 CFR 210.3 (b) (6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Opticap® XL 150 / 300/ 600 Disposable Capsules ( Sterile and Gamma Compatible) Millipore Express® SHR 0.5/0.1 µm Membrane with Prefilter |
|||
| Opticap® XL 150 Capsules | Opticap® XL 300 Capsules | Opticap® XL 600 Capsules | |
| Nominal Dimensions | |||
| Maximum length | 9.7 cm (3.8 in.) | 11.9 cm (4.7 in.) | 16.5 cm (6.5 in.) |
| Maximum length with bell | 11.4 cm (4.5 in.) | 13.7 cm (5.4 in.) | 18.3 cm (7.2 in.) |
| Body diameter | 5.6 cm (2.2 in.) | 5.6 cm (2.2 in.) | 5.6 cm (2.2 in.) |
| Filtration Area | 0.015 m2 (0.163 ft2) | 0.028 m2 (0.308 ft2) | 0.062 m2 (0.664 ft2) |
| Materials of Construction | |||
| Filter Membrane | Hydrophilic polyethersulfone | ||
| Supports | Polyethylene | ||
| Core | Polysulfone | ||
| Structural components* | Gamma stable polypropylene | ||
| Vent O-rings | Silicone | ||
| Bell | Polycarbonate | ||
| Vent Drain | 6 mm ( 1/4 in.) hose barb with double O-ring seal | ||
| Maximum Inlet Pressure | 6900 mbar (100 psi) intermittent at 23° C 5500 mbar (80 psi) at 23° C 2800 mbar (40 psi) at 60° C 1000 mbar (15 psi) at 80° C | ||
| Maximum Differential Pressure | |||
| Forward | 6900 mbar (100 psi) intermittent at 25° C 5500 mbar (80 psi) at 25° C 1000 mbar (15 psi) at 80° C | ||
| Reverse | 2100 mbar (30 psi) intermittent at 25° C | ||
| 70/30 IPA Bubble Point at 23° C | ≥2590 mbar (37.5 psi) with nitrogen | ||
| Air Diffusion at 23° C | Through a water wet membrane at 3.4 bar (50 psi): | ||
| ≤1.0 cc/min. | ≤1.9 cc/min. | ≤3.7 cc/min. | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC° 19146 per ASTM° methodology | ||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC® 23206 and our validated test method. | ||
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| TOC/Conductivity | Autoclaved filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| 1 L | 2 L | 3 L | |
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a WFI flush of 1 L. | ||
| Sterilization | |||
| Gamma Compatible | Gamma compatible to 45 kGy, may be autoclaved for 3 cycles of 60 minutes at 123° C. ( Cannot be steam sterilized in-line.) | ||
| Sterile capsules | May be autoclaved for 3 cycles of 60 minutes at 123° C. ( Cannot be steam sterilized in-line.) | ||
| Sterility | |||
| Sterile capsules | These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | ||
| Component Material Toxicity | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics. Millipore Express® SHR filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5. | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Non-fiber Releasing | Millipore Express® SHR membranes meet the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b)(6). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
Millipore Express® SHR with Prefilter 0.5/0.1 μm Membrane
| Opticap® XL 3 Capsules | Opticap® XL 5 Capsules | Opticap® XL 10 Capsules | Per Standard Area Opticap®XLT 10 Capsules | Per High Area Opticap® XLT 10 Capsules** | |
| Nominal Dimensions | |||||
| Maximum length | 17.3 com (6.8 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | 38.1 cm (15.0 in.) | 38.1 cm (15.0 in.) |
| Body diameter | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) |
| Fitting to Fitting | |||||
| Sanitary flange to sanitary flange | - | 15.2 cm (6.0 in.) | |||
| Sanitary flange to hose barb | - | 17.5 cm (6.9 in.) | |||
| Hose barb to hose barb | - | 19.8 cm (7.8 in.) | |||
| Filtration Area | 0.13 m2 (1.4 ft2) | 0.24 m2 (2.6 ft2) | 0.54 m2 (5.8 ft2) | 0.54 m2 (5.8 ft2) | 1.0 m2 (10.8 ft2) |
| Materials of Construction | |||||
| Filter membrane | Hydrophilic polyethersulfone | ||||
| Film edge | Polypropylene | ||||
| Supports | Polypropylene | ||||
| Core | Polysulfone | Polyethersulfone | |||
| Structural components* | Polypropylene | ||||
| Vent O-rings | Silicone | ||||
| Vent/Drain | 6 mm (¼ in.) hose barb with double O-ring seal | ||||
| Maximum Inlet Pressure | |||||
| 6900 mbar (100 psi) intermittent at 23 °C | |||||
| 5500 mbar (80 psi) at 23 °C | |||||
| 2800 mbar (40 psi) at 60 °C | |||||
| 1000 mbar (15 psi) at 80 °C | |||||
| Maximum Differential Pressure | |||||
| Forward | 6900 mbar (100 psi) intermittent at 25 °C 5500 mbar (80 psi) at 25 °C 1000 mbar (15 psi) at 80 °C |
||||
| Reverse | 2100 mbar (30 psi) intermittent at 25 °C | ||||
| 70/30 IPA Bubble Point at 23 °C | ≥2590 mbar (37.5 psi) with nitrogen | ||||
| Air Diffusion at 23 °C | Through a water wet membrane at 3.4 bar (50 psi): | ||||
| ≤7.3 cc/min. | ≤13.6 cc/min. | ≤30.4 cc/min. | ≤30.4 cc/min. | ≤54.2 cc/min. | |
| Bacterial Retention | Quantitative retention of 107 CFU /cm2 Brevundimonas diminuta ATCC® 19146 per ASTM® methodology | ||||
| Mycoplasma Removal | Typical Log Reduction Value (LRV) >7 using A. laidlawii ATCC® 23206 and our validated test method | ||||
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) | ||||
| TOC/Conductivity at 25 °C | Gamma sterilized filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: | ||||
| 5.5 L | 9.5 L | 21 L | 21 L | 21 L | |
| Oxidizable Subtances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of 2 L. | ||||
| Sterilization | |||||
| Gamma-compatible capsules | Gamma compatible to 45 kGy, may be autoclaved for 3 cycles of 60 minutes at 123 °C (Cannot be steam sterilized in-line) | ||||
| Sterile capsules | May be autoclaved for 3 cycles of 60 minutes at 123 °C (Cannot be steam sterilized in-line) | ||||
| Sterility | |||||
| Sterile capsules | These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | ||||
| Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||||
| Non-fiber Releasing | Millipore Express® SHR membranes meet 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. Millipore Express® SHC filters meet the requirements of the USP <88> Safety Test, utilizing a 0.9% sodium chloride extraction. | ||||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182. | ||||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||||
| *Cage, end caps and capsule housing | |||||
| **Only available in gamma-compatible formats | |||||
Typical Clean Water Flow Rate vs Pressure Drop (Sterile and Gamma Compatible Capsules)
Opticap® XL 3 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XL 5 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XL 10 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XLT 10 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XLT 20 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane
Opticap® XLT 30 Capsule Filters with 0.5/0.1 µm Millipore Express® SHR Membrane