Opticap XL and XLT Disposable Capsule Filters with Millipore Express^® SHR Hydrophilic Membrane

Opticap XL and XLT Disposable Capsule Filters with Millipore Express® SHR Hydrophilic Membrane

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



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

*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

CHO Serum-free Cell Culture Media



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 Capsule Filters have a unique design that minimizes hold-up volume and reduces production losses. Opticap XL 150, 300, 600, 3, 5 and 10 capsules are available with Millipore Express SHR membranes.

The Opticap XLT 10, 20 and 30 T-line Capsule Filters T-line design accommodates series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap XLT into your existing process.

They all exist as autoclavable, sterile or gamma-compatible devices.


Specifications (Autoclavable Capsules)    (return to top)

Opticap XL3 Opticap XL5 Opticap XL10 Filtration Area, m2 0.13 0.23 0.49 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polypropylene Polypropylene Polypropylene Supports Polypropylene Polypropylene Polypropylene Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double silicone O-ring seal Maximum Inlet Pressure, bar (psid) 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C Maximum Differential Pressure, bar (psid) Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent Bubble Point at 23 °C ≥2586 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 methodology. Mycoplasma Removal Typical Log Reduction Value (LRV) ≥ 7 using A. laidlawii ATCC 23206 and Millipore's standard test method Bacterial Endotoxins <0.25 EU/mL as determined by the 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: 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 Passes USP test for particulates in injectables. 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 Device Good Manufacturing Practices.

Opticap XLT 10 Opticap XLT 20 Opticap XLT 30 Filtration Area, m2 0.49 0.98 1.48 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polypropylene Polypropylene Polypropylene Supports Polypropylene Polypropylene Polypropylene Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double silicone O-ring seal Maximum Inlet Pressure, bar (psid) 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C Maximum Differential Pressure, bar (psid) Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent Bubble Point at 23 °C ≥2586 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 methodology. Mycoplasma Removal Typical Log Reduction Value (LRV) ≥ 7 using A. laidlawii ATCC 23206 and Millipore's standard test method Bacterial Endotoxins <0.25 EU/mL as determined by the 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: 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. USP Toxicity Non-toxic per MEM elution ISO® 10993-5 Particle Shedding Passes USP test for particulates in injectables. 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 Device 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

Specifications (Sterile and Gamma Compatible Capsules)    (return to top)

Opticap XL 150 Opticap XL 300 Opticap XL 600 Filtration Area, m2 0.02 0.03 0.06 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Supports Polyethylene Polyethylene Polyethylene Structural Components Gamma stable polypropylene/Polysulfone Gamma stable polypropylene/Polysulfone Gamma stable polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Maximum Inlet Pressure, bar (psid) 6.9 (100) intermittent @ 23 °C; 5.5 (80) @ 23 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C Maximum Differential Pressure, bar (psid) Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent Bubble Point at 23 °C ≥2586 mbar (37.5 psig) nitrogen with 70//30 % IPA/water Air Diffusion at 23 °C ≤1.0 mL/min @ 3.45 bar (50 psig) in water ≤1.9 mL/min @ 3.45 bar (50 psig) in water ≤3.7 mL/min @ 3.45 bar (50 psig) in water 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 Millipore's standard test method Bacterial Endotoxins <0.25 EU/mL as determined by the 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 liter 2 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 Gamma compatible to 45 kGy; 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. USP Toxicity Non-toxic per MEM elution ISO® 10993-5 Particle Shedding Passes USP test for particulates in injectables. 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 Device Good Manufacturing Practices.

Opticap XL3 Opticap XL5 Opticap XL10 Filtration Area, m2 0.13 0.24 0.54 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polypropylene Polypropylene Polypropylene Supports Polyester Polyester Polyester Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double silicone O-ring seal Maximum Inlet Pressure, bar (psid) 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C Maximum Differential Pressure, bar (psid) Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent Bubble Point at 23 °C ≥2586 mbar (37.5 psig) nitrogen with 70//30 % IPA/water Air Diffusion at 23 °C ≤7.3 mL/min @ 3.45 bar (50 psig) in water ≤13.6 mL/min @ 3.45 bar (50 psig) in water ≤30.4 mL/min @ 3.45 bar (50 psig) in water 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 Millipore's standard test method Bacterial Endotoxins <0.25 EU/mL as determined by the 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: 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 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. USP Toxicity Non-toxic per MEM elution ISO® 10993-5 Particle Shedding Passes USP test for particulates in injectables. 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 Device Good Manufacturing Practices.

Opticap XLT 10 Opticap XLT 20 Opticap XLT 30 Filtration Area, m2 0.54 1.08 1.62 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polypropylene Polypropylene Polypropylene Supports Polyester Polyester Polyester Structural Components Polypropylene/Polysulfone Polypropylene/Polysulfone Polypropylene/Polysulfone Vent O-ring Silicone Silicone Silicone Vent/Drain 1/4 in. hose barb with double silicone O-ring seal Maximum Inlet Pressure, bar (psid) 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 2.75 (40) @ 60 °C; 1.0 (15) @ 80 °C Maximum Differential Pressure, bar (psid) Forward: 6.9 (100) intermittent @ 25 °C; 5.5 (80) @ 25 °C; 1.0 (15) @ 80 °C. Reverse: 2.1 (30) @ 25 °C, intermittent Bubble Point at 23 °C ≥2586 mbar (37.5 psig) nitrogen with 70//30 % IPA/water Air Diffusion at 23 °C ≤30.4 mL/min @ 3.45 bar (50 psig) in water ≤60.8 mL/min @ 3.45 bar (50 psig) in water ≤91.2 mL/min @ 3.45 bar (50 psig) in water 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 Millipore's standard test method Bacterial Endotoxins <0.25 EU/mL as determined by the 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: 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 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. USP Toxicity Non-toxic per MEM elution ISO® 10993-5 Particle Shedding Passes USP test for particulates in injectables. 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 Device Good Manufacturing Practices.

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