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

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

Description
Millipore Express SHC (Sterilizing grade High Capacity) devices offer high performance and superior economics in a wide variety of sterilizing grade filtration applications. Millipore Express SHC filters are designed for use across a range of low to high-fouling process solutions including: cell culture media and media additives, process intermediates, buffers, cleaning and sanitizing solutions, and protein-containing solutions. Millipore Express SHC devices provide sterility assurance, broad chemical compatibility, high flow rates and exceptionally high capacity for non-fouling and moderate- to high-fouling fluids.

Millipore Express SHC filters have an on-board polyethersulfone membrane prefilter which protects the sterilizing grade membrane from premature plugging and extends filtration capacity so you get sterilizing grade performance with superior throughput. Millipore Express SHC devices provide you with a single solution for a range of process fluids, minimizing validation efforts and simplifying filter inventory and stocking requirements. With Millipore Express SHC filters, you increase productivity, shorten cycle-time and reduce costs.


One Filter for Sterilizing Grade Application Needs
- Cell culture media
- Media additives
- Column protection
- Concentrated protein streams
- Cell harvest (post clarification)
- Caustics/pH adjusters
- Buffers
- CIP solutions


Faster Filtration
Millipore Express SHC 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 superior throughput performance for media and other high fouling applications.


Reliable Performance
Millipore Express SHC filters deliver higher throughput and all the benefits you’d expect from a quality Millipore filter.
- Reliable sterilizing performance
- High flow rates
- Multiple steam-in-place or autoclave sterilization cycles
- Broad chemical compatibility
- Easy integrity testing
- Superior efficiency and process economy


Increased Throughput for Lower Filtration Costs
The on-board polyethersulfone membrane prefilter extends filter capacity so you can maintain batch volume while reducing filtration surface area. This high-throughput benefit has been shown to deliver up to a 50 percent savings in filtration costs, improving your process economics.


Fewer Filter Change outs and Extended Capacity
Millipore Express SHC filters are designed to maximize the capacity of constrained filtration systems. With its high flux and superior dirt holding capacity, you can double your output without significant capital expense.


Regulatory Compliance
Millipore Express SHC filters are designed, developed and manufactured in accordance with a Quality Management System approved by an accredited registering body of an ISO^® 9000 Quality Systems Standard. Each device is shipped with a Certificate of Quality. All devices are 100% integrity tested during manufacture and supported by a Validation Guide for compliance with regulatory requirements.

For traceability and easy identification, each filter is identified with product name and other characteristics.


Multiple Formats Available
Opticap Capsule Filters have a unique design that minimizes hold-up volume and reduces production losses. Opticap XL 150, 300, 600, 3, 5 and 10 are available with Millipore Express SHC 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, gamma-compatible or sterile 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 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 ≥4000 mbar (58 psig) air with water Air Diffusion ≤7.3 mL/min @ 2.75 bar (40 psig) in water ≤13.3 mL/min @ 2.75 bar (40 psig) in water ≤28.2 mL/min @ 2.75 bar (40 psig) in water Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. 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 at 25 °C per 10-inch element 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 Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 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.

Opticap XLT10 Opticap XLT20 Opticap XLT30 Filtration Area, m2 0.49 0.98 1.47 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 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 ≥4000 mbar (58 psig) air with water Air Diffusion ≤28.2 mL/min @ 2.75 bar (40 psig) in water ≤56.3 mL/min @ 2.75 bar (40 psig) in water ≤84.5 mL/min @ 2.75 bar (40 psig) in water Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. 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 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: 40 liters 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: 60 liters at 25 °C 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 Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 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.

Typical Clean Water Flow Rate vs Pressure Drop (Autoclavable Capsules)

Opticap XL 3 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XL 5 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XL 10 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XLT 10 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XLT 20 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XLT 30 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

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

Opticap XL 150 Opticap XL 300 Opticap XL 600 Filtration Area, m2 0.01 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 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 ≥4000 mbar (58 psig) air with water Air Diffusion ≤1.0 mL/min @ 2.75 bar (40 psig) in water ≤1.9 mL/min @ 2.75 bar (40 psig) in water ≤3.7 mL/min @ 2.75 bar (40 psig) in water Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. 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 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: 2 liters 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: 3 liters at 25 °C 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; 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 Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 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.

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 Polyethylene Polyethylene Polyethylene 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 O-ring seal 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 ≥4000 mbar (58 psig) air with water Air Diffusion ≤7.6 mL/min @ 2.75 bar (40 psig) in water ≤14 mL/min @ 2.75 bar (40 psig) in water ≤31.2 mL/min @ 2.75 bar (40 psig) in water Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. 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: 21 liters at 25 °C per 10-inch element 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 capsules 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 Sterility Sterile 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. USP Toxicity Non-toxic per MEM elution ISO® 10993-5 Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 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.

Opticap XLT10 Opticap XLT20 Opticap XLT30 Filtration Area, m2 0.54 1.09 1.63 Materials of Construction Filter Hydrophilic polyethersulfone Hydrophilic polyethersulfone Hydrophilic polyethersulfone Film Edge Polyethylene Polyethylene Polyethylene 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 O-ring seal 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 ≥4000 mbar (58 psig) air with water Air Diffusion ≤31.2 mL/min @ 2.75 bar (40 psig) in water ≤62.5 mL/min @ 2.75 bar (40 psig) in water ≤93.7 mL/min @ 2.75 bar (40 psig) in water Bacterial Retention Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta ATCC® 19146 per ASTM methodology. 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: 21 liters 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: 42 liters 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: 63 liters at 25 °C 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 capsules 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 Sterility Sterile 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. USP Toxicity Non-toxic per MEM elution ISO® 10993-5 Good Manufacturing Practices These products are manufactured in a facility which adheres to FDA Device Good Manufacturing Practices. 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.

Typical Clean Water Flow Rate vs Pressure Drop (Sterile and Gamma Compatible Capsules)

Opticap XL 3 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XL 5 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XL 10 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XLT 10 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XLT 20 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane

Opticap XLT 30 Capsule Filters with 0.5/0.2 µm Millipore Express SHC Membrane