Millipore Express® SHC 0.5/0.2 μm Cartridge Filters
Recommended Products
Overview
Specifications
Ordering Information
Documentation
Material Qualification Dossier
| Title | Version |
|---|---|
| 1.0 |
Quality Management Dossier (Open Access)
| Title |
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Operational Excellence Dossier
| Title |
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Technical Info
Data Sheet
| Title |
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| Millipore Express® Family Guide |
Posters
| Title |
|---|
| Quality by Design (QbD) Principles in Aseptic Processing |
References
| Reference overview |
|---|
| "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 |
User Guides
| Title |
|---|
| User Guide - Filters with Millipore Express®Membrane |
| Vmax Constant Pressure |
| Wetting Instructions for Filter Units with Durapore Membrane |
Related Products & Applications
Product Families
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Millipore Express® SHC 0.5/0.2 μm Capsule FiltersMillipore Express® SHC (Sterilizing-grade High Capacity) devices offer high performance and superior economics in a wide variety of sterilizing-grade filtration applications.Learn More >> |
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.Learn More >> |
Related Products By: Application Facete
| Antibody Purification |
| Dialysis and Filtration |
Related Products By: Brand Facete
| Millipore Express® |
Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHC |
Millipore Express® SHC filters have an on-board polyethersulfone membrane prefilter which protects the 0.2 μm membrane from premature plugging and extends filtration capacity, so you get sterilizing-grade performance with superior throughput. Millipore Express® SHC filters 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 cost.
Filter formats
Millipore Express® SHC filters are offered in a range of filter formats and capsule sizes, and allow easy scale-up of your small volume filtration steps to larger, full-scale filtration processes.
- 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
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 (1-14) — caustic compatible
Applications
- Media additives
- Column protection
- Concentrated protein streams
- Cell harvest (post clarification)
- Caustics/pH adjusters
- Buffers
- CIP solution
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 (see figures 1 and 2).
)
CHO Cell Culture Growth Media: No Prefiltration
)
Protein Concentrate Post Ultrafiltration
The Emprove® Program
The Emprove® Program complements the product portfolio through
- Comprehensive documentation to support qualification, risk assessment and process optimization needs.
- Consolidation of product specific testing, quality and regulatory information to simplify compliance requirements.
- Convenient 24/7 access to up-to-date product information.
| Cartridge Filters | |||
| 5-inch Cartridge | Per Standard Area 10-inch Filter Cartridge | Per High Area 10-inch Filter Cartridge | |
| Nominal Dimensions | |||
| Diameter: | 6.9 cm (2.7 in.) | ||
| Length: | 12.5 cm (5 in.) | 25.4 cm (10 in.) | |
| Filtration Area | 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 | ||
| Film edge: | Polypropylene | ||
| Supports: | Polypropylene | ||
| Cage and end caps: | Polypropylene | ||
| Core: | Polysulfone | Polyethersulfone | |
| O-rings: | Silicone, EPDM or fluoroelastomer | Silicone, EPDM or fluoroelastomer | |
| Maximum Differential Pressure | |||
| 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 340 mbar (5 psi) at 135 °C |
|
| 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 |
|
| Bubble Point at 23 °C | ≥ 4000 mbar (58 psi) air with water | ||
| Air Diffusion at 23 °C | Through a water wet membrane at 2.8 mbar (40 psi): | ||
| ≤13.3 cc/min. | ≤ 28.2 cc/min. | <56.4 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 using the Limulus Amebocyte Lysate (LAL) test. | ||
| TOC/Conductivity at 25 °C | Autoclaved filter effluent meets the WFI specification for USP <643>, Total Organic Carbon, and for USP <645>, Conductivity, after a WFI flush of: | ||
| 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 2000 mL. | ||
| Sterilization | Autoclave: 25x, 60 min. cycles at 126 °C In-line steam*: 25 forward cycles, 30 min., 135 ºC at ≤ 340 mbar (5 psi) or, 22 forward cycles, 30 min., 135 ºC at ≤ 340 mbar (5 psi) and 3 reverse cycles, 30 min., 135 ºC at < 69 mbar (1 psi) or 3 forward cycles, 30 min., 135 ºC at ≤ 1000 mbar (15 psi) |
Autoclave: 5x, 60 min. cycles at 126 °C In-line steam*: 5x forward cycles, 30 min., 135 °C at ≤ 340 mbar (5 psi) |
|
| 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. | ||