Millipore Express SHC 0.5/0.2 μm Hydrophilic Filters
Millipore Express SHC filters provides sterility assurance,
broad chemical compatibility, high flow rates and exceptionally high capacity
for non-fouling to and moderate-to high-fouling fluids. With an onboard
polyethersulfone membrane prefilter, which protects the membrane from premature
plugging and extends filtration capacity, you can easily get sterilizing-grade
performance with superior throughput.
These filters provide you with
a single solution for a range of process fluids, minimizing validation efforts
and simplifying filter inventory and stocking requirements. As a result,
Millipore Express SHC filters can increase your productivity, shorten cycle
time and reduce costs.
One Filter for Sterilizing Grade Application Needs
- Serum-free cell culture media
- Media additives
- Column protection
- Concentrated
protein streams
- Cell harvest (post-clarification)
- Caustics/pH adjusters
- Buffers
- CIP solutions
Benefits
- High capacity, high-flux
hydrophilic PES membranes
- Validated sterilizing-grade performance
- Easy wetting and integrity testing
- Superior throughput in
high-fouling streams, including media and protein containing solutions
- Increased capacity for improved process efficiency and economy
- Broad chemical compatibility across a wide pH range – caustic compatible
| OptiScale Disposable Capsules and Cartridge Filters | ||||
| OptiScale 25 Capsules | OptiScale 47 Capsules | 5-inch Cartridge | Per 10-inch Filter Cartridge | |
| Nominal Dimensions | ||||
| Diameter: | 31 mm (1.21 in.) | 69 mm (2.75 in.) | 6.9 cm (2.7 in.) | |
| Length: | 39 mm (1.52 in.) | 82 mm (3.24 in.) with flange inlet/hose barb
outlet 74 mm (2.91 in.) with flange inlet/flange outlet 94 mm (3.70 in.) with hose barb inlet/hose barb outlet |
12.5 cm (5 in.) | 25.4 cm (10 in.) |
| Filtration Area | 3.5 cm² | 17.7 cm² | 0.23 m² (2.5 ft²) | 0.49 m² (5.3 ft²) |
| Materials of Construction | ||||
| Filter membrane: | Hydrophilic polyethersulfone | |||
| Film edge: | — | Polypropylene | ||
| Supports: | — | Polypropylene | ||
| Cage and end caps: | — | Polypropylene | ||
| Core: | — | Polysulfone | ||
| Structural components: | Polypropylene | Polycarbonate | — | |
| Vent cap: | Polypropylene | Polyvinylidene fluoride (PVDF) | — | |
| O-rings: | Fluorocarbon rubber | Silicone, EPDM or fluorocarbon rubber | ||
| Housing Vent | Capped vent with female Luer connections on inlet side of device. | Adjustable vent with male Luer and female Luer-Lok® connections on inlet side of the device | — | |
| Maximum Inlet Pressure | 4136 mbar (60 psi) at 25 °C | 5515 mbar (80 psi) at 25 °C | — | |
| Maximum Differential Pressure | ||||
| Forward: | 4136 mbar (60 psi) at 25 °C | 5515 mbar (80 psi) at 25 °C | 6895 mbar (100 psi) at 25 °C 1700 mbar (25 psi) at 80 °C 1000 mbar (15 psi) at 135 °C* |
|
| Reverse: | 0 mbar (0 psi) | 700 mbar (10 psi) at 25 °C | 2068 mbar (30 psi) at 25 °C 69 mbar (1 psi) at 135 °C* |
|
| Bubble Point at 23 °C | — | — | ≥ 4000 mbar (58 psi) air with water | |
| Air Diffusion at 23 °C | — | — | Through a water wet membrane at 2758 mbar (40 psi): | |
| ≤13.3 cc/min. | ≤ 28.2 cc/min. | |||
| Bacterial Retention | — | — | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC® 19146 per ASTM® methodology. | |
| Bacterial Endotoxin | Aqueous extraction contains < 0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL) Test. | — | Aqueous extraction contains | |
| TOC/Conductivity | This product exhibited less than 500 ppb TOC per USP <643> and less than 1.3 µm per USP <645> after autoclave and WFI water flush of 15 mL. | — | Autoclaved cartridges meet the WFI of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | |
| 9.5 L at 25 °C | 20 L at 25 °C | |||
| Oxidizable Substances | — | Effluent meets the USP Oxidizable Substance Test requirements for sterile purified water after a water flush of: | ||
| ≤100 mL | 2000 mL | |||
| Sterilization | May be autoclaved for 1 cycle at 123 °C for 60 min. | May be autoclaved for 3 cycles at 126 °C for 60 min. | Autoclave: 25x, 60 min. cycles at 126 °C In-line steam*: 25 forward cycles, 30 min., 135 ºC at ≤ 340 mbar (5 psid) or, 22 forward cycles, 30 min., 135 ºC at ≤ 340 mbar (5 psid) and 3 reverse cycles, 30 min., 135 ºC at < 69 mbar (1 psid) or 3 forward cycles, 30 min., 135 ºC at ≤ 1000 mbar (15 psid) |
|
| USP Toxicity | — | — | Non-toxic per MEM elution ISO® 10993-5. | |
| Particle Shedding | Passes USP test for particulates in injectables. | — | Passes USP test for particulates in injectables. | |
| Non-fiber Releasing | Millipore Express SHC 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. | |||
| * Cartridges only. Capsules are not rated for 135 °C and should never be in-line steamed. | ||||
| Opticap XL and XLT Disposable Capsules (Autoclavable only) | ||||||
| Opticap (Model) | XL 3 | XL 5 | XL 10 | XLT 10 | XLT 20 | XLT 30 |
| Nominal Dimensions | ||||||
| Maximum length: | 17.3 cm (6.8 cin.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | 37.7 cm (14.8 in.) | 62.5 cm (24.6 in.) | 87.2 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 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) | 0.23 m² (2.5 ft²) | 0.49 m² (5.3 ft²) | 0.98 m² (10.5 ft²) | 1.48 m² (15.8 ft²) | |
| Materials of Construction | ||||||
| Filter membrane: | Hydrophilic polyethersulfone | |||||
| Film edge: | Polypropylene | |||||
| Supports: | Polypropylene | |||||
| Structural components*: | Polypropylene | |||||
| Core: | Polysulfone | |||||
| Vent O-rings**: | Silicone | |||||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | |||||
| Maximum Inlet Pressure | 6895 mbar (100 psi) intermittent at 23 °C 5515 mbar (80 psi) at 23 °C 2758 mbar (40 psi) at 60 °C 1035 mbar (15 psi) at 80 °C |
|||||
| Maximum Differential Pressure | ||||||
| Forward: | 6895 mbar (100 psi) intermittent at 25 °C 5515 mbar (80 psi) at 25 °C 1035 mbar (15 psi) at 80 °C |
|||||
| Reverse: | 2068 mbar (30 psi) intermittent at 25 °C | |||||
| Bubble Point at 23 °C | ≥4000 mbar (58 psi) air with water | |||||
| Air Diffusion at 23 °C | Through a water wet membrane at 2758 mbar (40 psi): | |||||
| ≤7.3 cc/min. | ≤13.3 cc/min. | ≤28.2 cc/min. | ≤56.3 cc/min. | ≤84.5 cc/min. | ||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC® 19146 per ASTM® methodology | |||||
| Bacterial Endotoxin | Aqueous extraction contains | |||||
| 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 L | 9.5 L | 20 L | 40 L | 60 L | ||
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of: | |||||
| ≤ 2000 mL | ≤ 4000 mL | ≤ 6000 mL | ||||
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | |||||
| USP Toxicity | Non-toxic per MEM elution ISO 10993-5. | |||||
| Particle Shedding | Passes USP test for particulates in injectables. | |||||
| Non-Fiber Releasing | Millipore Express SHC 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 | ||||||
| ** EPDM and fluorocarbon O-rings available by custom order | ||||||
| Opticap XL and XLT Disposable Capsules (Sterile and Gamma Compatible) | |||||||||
| Opticap (Model) | XL 150 | XL 300 | XL 600 | XL 3 | XL 5 | XL 10 | XLT 10 | XLT 20 | XLT 30 |
| Nominal Dimensions | |||||||||
| Maximum length: | 9.7 cm (3.8 in.) |
11.9 cm (4.7 in.) |
16.5 cm (6.5 in.) |
17.3 cm (6.8 in.) |
21.6 cm (8.5 in.) |
33.5 cm (13.2 in.) |
37.7 cm (14.8 in.) |
62.5 cm (24.6 in.) |
87.2 cm (34.3 in.) |
| Body diameter: | 5.6 cm (2.2 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 | 0.014 m² (0.155 ft²) |
0.029 m² (0.316 ft²) |
0.059 m² (0.631 ft²) |
0.13 m² (1.4 ft²) |
0.24 m² (2.6 ft² ) |
0.54 m² (5.8 ft² ) |
1.09 m² (11.7 ft² ) |
1.63 fm² (17.5 fft² ) |
|
| Materials of Construction | |||||||||
| Filter membrane: | Hydrophilic polyethersulfone | ||||||||
| Film edge: | — | Polyethylene | |||||||
| Supports: | Polyethylene | Polyester | |||||||
| Structural components*: | Gamma stable polypropylene | Polypropylene | |||||||
| Core: | Polysulfone | ||||||||
| Vent O-rings**: | Silicone | ||||||||
| Vent/Drain | ¼ in. hose barb with double O-ring seal | ||||||||
| Maximum Inlet Pressure | 6895 mbar (100 psi) intermittent at 23 °C 5515 mbar (80 psi) at 23 °C 2758 mbar (40 psi) at 60 °C |
||||||||
| Maximum Differential Pressure | |||||||||
| Forward: | 6895 mbar (100 psi) intermittent at 23 °C 5515 mbar (80 psi) at 23 °C 2758 mbar (40 psi) at 60 °C 1035 mbar (15 psi) at 80 °C |
||||||||
| Reverse: | 2068 mbar (30 psi) intermittent at 25 °C | ||||||||
| Bubble Point at 23 °C | ≥4000 mbar (58 psi) air with water | ||||||||
| Air Diffusion at 23 °C | Through a water wet membrane at 2758 mbar (40 psi): | ||||||||
| ≤ 1.0 cc/min. | ≤1.9 cc/min. | ≤ 3.7 cc/min. | ≤ 7.6 cc/min. | ≤14.0 cc/min. | ≤ 31.2 cc/min. | ≤ 62.5 cc/min. | ≤93.7 cc/min. | ||
| Bacterial Retention | Quantitative retention of 107 CFU/cm² Brevundimonas diminuta ATCC® 19146 per ASTM® methodology. | ||||||||
| Bacterial Endotoxin | Aqueous extraction contains | ||||||||
| 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: | ||||||||
| 1 L | 2 L | 3 L | 5.0 L | 9.5 L | 21 L | 42 L | 63 L | ||
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of: | ||||||||
| ≤1000 mL. | ≤2000 mL | ≤ 4000 mL | ≤ 6000 mL | ||||||
| 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: | Meets current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | ||||||||
| USP Toxicity | Non-toxic per MEM elution ISO 10993-5. | ||||||||
| Particle Shedding | Passes USP test for particulates in injectables. | ||||||||
| Non-Fiber Releasing | Millipore Express SHC membranes meet the criteria for a “non-fiber releasing” filter as defined in 21 CFR 210.3(b)(6). | ||||||||
| Component Material | Component materials were tested and meet the criteria of the USP <88> Reactivity Test for Class VI plastics | ||||||||
| Toxicity | 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. | |||||||||
| ** EPDM and fluorocarbon O-rings available by custom order." | |||||||||
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