Millipore Express® SHR 0.1 μm and 0.5/0.1 µm Cartridge Filters
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Material Qualification Dossier
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| 3.0 |
Quality Management Dossier (Open Access)
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Operational Excellence Dossier
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| Mobile Phase Preparation for UHPLC: Membrane Filtration Method Affects System Performance and Leaching of Extractable Impurities Subodh Kulkarn(1), Jesmi George(2) and Vivek Joshi(2) (1) Millipore India Pvt. Ltd., Bioscience Division, 50A, 2nd Phase, Ring Road, Peenya, Bangalore, India 560058 (2) Millipore Corp., Bioscience Division, 17 Cherry Hill Drive, Danvers, MA 01923 LCGC 2010 Mostrar Resumo UHPLC/UPLC® is a revolutionary chromatography technique that is gaining wide acceptance among researchers due to improved resolution, shorter chromatographic runs, and the capability for doing fast method development. The presence of sub-2 µm particles in UHPLC columns provide these benefits but also poses challenges in sample and mobile phase preparation. Particulate impurities in the sample or mobile phase can cause backpressure buildup in the UHPLC system, causing system failure. In fact, most UHPLC instrument vendors recommend filtration of mobile phase using 0.2 µm filters, but there is a lack of data showing the benefits of filtration. In this article we describe the filtration of mobile phases through syringe filters of varying pore size and membrane type, followed by analysis by UHPLC and mass spectrometry. Our results clearly indicate that filtration of mobile phase components using the optimal membrane filter will help protect UHPLC systems from particulate impurities that may clog and shut down the system, increase the sensitivity of detection, and improve the accuracy of quantitation. Texto completo do artigo |
| "Schneller und effizienter" (Faster and more efficient) Ulrich Hoebel, Key Account Manager for Boehringer Ingelheim & Regional Sales Manager in Central Area Biotechnica Today, official journal of the Hannover tradeshow Biotechnica, published by the German magazine Laborpraxis, issue October 18 2005, page 9 2005 |
| Filtración esterilizante rápida y económica: tecnologia de membrana Express® (Faster Sterile Filtration with New Membrane Technology) Josep Vilella, Bioprocess Marketing, Tech Service and internal Support Specialist in Spain Tecnicas de Laboratorio (Spanish magazine), issue 306, November 2005 , page 975 2005 |
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Famílias de produtos
OptiScale® Capsule Filters for Aseptic Processing ApplicationsOptiScale® capsules, with a large variety of filtration media options, are a family of convenient, disposable filters ideal for media selection, process screening and scaling.Saiba mais >> |
Millipore Express® SHR Opticap® Capsule FiltersMillipore Express® SHR (Sterile High-retention) devices provide sterilizing-grade performance and mycoplasma removal across a range of bioprocess solutions.Saiba mais >> |
Produtos relacionados por: Application Facete
| Antibody Purification |
| Dialysis and Filtration |
Produtos relacionados por: Brand Facete
| Millipore Express® |
Categorias
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHR |
Devices containing Millipore Express® SHR (Sterile, High-Retention) membrane 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. These devices provide high sterility assurance, broad chemical compatibility, high flow rates and extended throughput for superior process efficiency and economy. The optional on-board polyethersul-fone membrane prefilter protects the high-flux sterilizing-grade 0.1 μm rated membrane from premature plugging, allowing for enhanced throughput in high-fouling streams.
Benefits
- High-flux and devices with increased area reduce the number of filters required for improved process economy
- Designed and qualified for sterilizing-grade performance and mycoplasma removal
- Available with an on-board PES membrane prefilter for extended throughput in high-fouling media
- Robust construction that will withstand multiple sterilization cycles
- Easy wetting and integrity testing
- Broad chemical compatibility across a wide pH range (pH 1–14)
Filter Formats
- OptiScale® small-scale disposable capsule filters
- Opticap® XL 150/300/600 small-scale disposable capsule filters with optional filling bell—gamma compatible or presterilized
- Opticap® XL disposable capsule filters—autoclavable, gamma compatible, or presterilized
- Opticap® XLT disposable capsule filters—autoclavable, gamma compatible, or presterilized
- Standard and high area cartridge filters
Filter Applications
- Mycoplasma protection
- Cell culture media
- Media additives
- Serum
- Process intermediates
Sterilizing-Grade Filters
Sterilizing-grade Millipore Express® SHR 0.1 μm rated membranes are available in the following filter formats and capsule sizes with an optional onboard prefilter:
- Membrane discs (25 mm and 47 mm)
- Standard area cartridge filters 5–30 inch available with silicone, EPDM or fluoroelastomer O-rings
- High area cartridge filters 10-30 inch available with silicone, EPDM or fluoroelastomer O-ring
- OptiScale® disposable scaling devices
- Opticap® XL 150, 300, 600, 3, 5 and 10 autoclavable, gamma-compatible or sterile capsules
- Opticap® XLT 10, 20 and 30 autoclavable, gamma-compatible or sterile capsules
Enhanced Sterility Assurance
Devices with Millipore Express® SHR sterilizing-grade membranes are designed for the removal of mycoplasma and small microorganisms that could 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 our validated test method.
| Cartridge Filters Millipore Express® SHR 0.1 µm and 0.1 µm with Prefilter Membranes |
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| 5-inch Cartridge | Per Standard Area 10-inch Cartridge | Per High Area 10-inch Cartridge | |
| Nominal Dimensions | |||
| Diameter: | 6.9 cm (2.7 in.) | 6.9 cm (2.7 in.) | 6.9 cm (2.7 in.) |
| Length: | 12.7 cm (5 in.) | 25.4 cm (10 in.) | 25.4 cm (10 in.) |
| Filtration Area | |||
| Millipore Express® SHR | 0.29 m2 (3.1 ft2) | 0.60 m2 (6.5 ft2) | - |
| Millipore Express® SHR w/ Prefilter | 0.23 m² (2.5 ft²) | 0.49 m² (5.3 ft²) | 1.0 m2 (10.8 ft2) |
| Materials of Construction | |||
| Filter membrane: | Hydrophilic polyethersulfone | Hydrophilic polyethersulfone | |
| Film edge: | Polypropylene | Polypropylene | |
| Supports: | Polypropylene | Polypropylene | |
| Cage and end caps: | Polypropylene | Polypropylene | |
| Core: | Polysulfone | Polyethersulfone | |
| O-rings: | Silicone, EPDM or fluorocelastomer | Silicone, EPDM or fluoroelastomer | |
| Maximum Differential Pressure | |||
| Millipore Express® SHR 0.1 µm | |||
| Forward: | 6900 mbar (100 psi) at 25 °C 1700 mbar (25 psi) at 80 °C 340 mbar (5 psi) at 135 °C* |
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| Reverse: | 2100 mbar (30 psi) at 25 °C 69 mbar (1 psi) at 135 °C |
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| Millipore Express® SHR with Prefilter | |||
| Forward: | 6900 mbar (100 psi) at 25 °C 1700 mbar (25 psi) at 80 °C 1000 mbar (15 psi) at 135 °C |
6900 mbar (100 psi) at 25 °C 1700 mbar (25 psi) at 80 °C 300 mbar (5 psi) at 135 °C* |
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| Reverse: | 2100 mbar (30 psi) at 25 °C 69 mbar (1 psi) at 135 °C |
2100 mbar (30 psi) at 25 °C 69 mbar (1 psi) at 135 °C |
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| 70/30 IPA Bubble Point at 23 °C | ≥ 2586 mbar (37.5 psi) with nitrogen | ||
| Air Diffusion at 23 °C | Through a water wet membrane at 3450 mbar (50 psi): | ||
| Millipore Express® SHR 0.1 µm: | ≤15.9 cc/min. | ≤33.3 cc/min. | - |
| Millipore Express® SHR w/Prefilter: | ≤12.8 cc/min. | ≤27.1 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 Millipore’s validated test method | ||
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL as determined using the Limulus Amebocyte Lysate (LAL) test. | ||
| TOC/Conductivity at 25 °C | Autoclaved cartridges meet the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI water flush of: | ||
| Millipore Express® SHR 0.1 µm: | 5.5 L | 10 L | - |
| Millipore Express® SHR w/Prefilter: | 9.5 L | 20 L | 20 L |
| Oxidizable Substances Effluent meets the USP Oxidizable Substance Test requirements for sterile purified water after a water flush of: |
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| Millipore Express® SHR 0.1 | 1000 mL | - | |
| Millipore Express® SHR w/ Prefilter | 2000 mL | 2000 mL | |
| Sterilization | |||
| Millipore Express® SHR | Autoclave: 25x, 60 min. cycles at 126 °C In-line steam: 25 forward cycles, 30 min., 135 °C at ≤ 300 mbar (5 psi) or, 22 forward cycles, 30 min., 135 °C at ≤ 300 mbar (5 psi) and 3 reverse cycles, 30 min., 135 °C at < 69 mbar (1 psi) |
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| Millipore Express® SHR w/Prefilter | Autoclave: 25x, 60 min. cycles at 126 °C In-line steam: 25x forward cycles, 30 min., 135 °C at ≤ 300 mbar (5 psi) or, 22 forward cycles, 30 min., 135 °C at ≤ 300 mbar (5 psi) and 3 reverse cycles, 30 min., 135 °C at < 69 mbar (1 psi) or, 3 forward cycles, 30 min., 135 °C at ≤ 1000 mbar (15 psi) |
Autoclave: 5X, 60 min. cycles at 126 °C In-line steam: 5X forward cycles, 30 min., ≤ 135°C at ≤ 300 mbar (5 psi) |
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| USP Toxicity | Non-toxic per MEM elution ISO®10993-5. | ||
| Particle Shedding | Passes USP test for particulates in injectables. | ||
| 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 | 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. | ||