Millipore Express® SHC 0.5/0.2 μm Capsule Filters
Millipore Express® SHC (Sterilizing-grade High Capacity) devices offer high performance and superior economics in a wide variety of sterilizing-grade filtration applications.
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Millipore Express® SHC (Sterilizing-grade High Capacity) devices offer high performance and superior economics in a wide variety of sterilizing-grade filtration applications. Weniger
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Material Qualification Dossier
| Titel | Version |
|---|---|
| 3.0 |
Quality Management Dossier (Open Access)
| Title |
|---|
Operational Excellence Dossier
| Title |
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Operational Excellence Dossier (Second Sterilization)
| Title |
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FAQ
| Frage | Antwort |
|---|---|
| Do Opticaps come pre-sterilized? | Opticaps are available in three formats:
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Verwandte Produkte nach: Application Facete
| Antibody Purification |
| Dialysis and Filtration |
Verwandte Produkte nach: Brand Facete
| Opticap® |
Kategorien
| Biopharmaceutical Manufacturing > Downstream Processing > Sterile Filtration > Sterile Liquid > Millipore Express® > Millipore Express® SHC |
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® XL 150, 300, and 600 capsule filters with Millipore Express® membranes are ideal for small volume sterile filling applications and process development work. An optional filling bell can be used to reduce contamination risk when transferring sterile media from large containers to media bottles or culture vessels.
Opticap® XL 3, 5, and 10 capsule filters have a unique design to minimize hold-up volume and reduce production losses.
Opticap® XLT 10, 20, and 30 T-line capsule filters design accomodates series or parallel filtration to match your application needs, and a specially-designed stand enables quick and easy integration of the Opticap XLT filter into your existing process.
All of these formats are available as gamma-compatible or sterile devices. Opticap® XL 3 and larger capsules are also available as autoclavable devices.
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.
| Family (FID) | |
| Express (FID19B) | |
| Organism Retention | Microorganism |
| Mode of Action | Filtration (size exclusion) |
| Application | BioProcessing |
| Intended Use | Reduction or removal of microorganism/bioburden |
| Instructions for Use | Please refer installation section of Opticap® XL Capsules and Opticap® XLT Capsules User Guide. |
| Storage Statement | Store in dry location. |
| Disposal Statement | Dispose of in accordance with applicable federal, state, and local regulations. |
| Label statement | Directions for use refer to website. |
| User Guides |
|
Autoclavable Capsules
| Opticap® XL 3 | Opticap® XL 5 | Opticap® XL 10 | |
| Filtration Area | 0.13 m² (1.4 ft²) | 0.23 m² (2.5 ft²) | 0.49 m² (5.3 ft²) |
| Materials of Construction | |||
| Filter Membrane | Polyethersulfone (PES) | ||
| Film Edge | Polypropylene | ||
| Supports | Polypropylene | ||
| Structural Components* | Polypropylene/Polysulfone | ||
| Vent O-ring | Silicone | ||
| Vent/Drain | 6 mm (¼ in.) hose barb with double silicone O-ring seal | ||
| Maximum Differential Pressure | |||
| Forward: | 6900 mbar (100 psi) intermittent @ 25 °C; 5500 mbar (80 psi) @ 25 °C; 1000 mbar (15 psi) @ 80 °C. | ||
| Reverse: | 2100 mbar (30 psi) @ 25 °C, intermittent | ||
| Bubble Point at 23 °C | ≥4000 mbar (58 psi) air with water | ||
| Air Diffusion at 23 °C | Through a water wet membrane at 2750 mbar (40 psi): | ||
| ≤7.3 cc/min. | ≤13.3 cc/min. | ≤28.2 cc/min. | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® methodology | ||
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of: | ||
| 2 L | 2 L | 2 L | |
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | ||
| TOC/Conductivity at 25 °C | Autoclaved filter effluent meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: | ||
| 5.5 L | 9.5 L | 20.0 L | |
| USP Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| 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. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| *Cage, end caps and capsule housing | |||
Autoclavable capsules
| Opticap® XLT 10 | Opticap® XLT 20 | Opticap® XLT 30 | |
| Filtration Area | 0.49 m² (5.3 ft²) | 0.98 m² (10.5 ft²) | 1.47 m² (15.8 ft²) |
| Materials of Construction | |||
| Filter | Polyethersulfone (PES) | ||
| Film Edge | Polypropylene | ||
| Supports | Polypropylene | ||
| Structural Components* | Polypropylene/Polysulfone | ||
| Vent O-ring | Silicone | ||
| Vent/Drain | 6 mm (¼ in.) hose barb with double silicone O-ring seal | ||
| Maximum Differential Pressure | |||
| Forward: | 6900 mbar (100 psi) intermittent @ 25 °C; 5500 mbar (80 psi) @ 25 °C; 1000 mbar (15 psi) @ 80 °C. | ||
| Reverse: | 2100 mbar (30 psi) @ 25 °C, intermittent. | ||
| Bubble Point at 23 °C | ≥4000 mbar (58 psi) air with water | ||
| Air Diffusion at 23 °C | Through a water wet membrane at 2750 mbar (40 psi): | ||
| ≤ 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 Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| TOC/Conductivity at 25 °C | Autoclaved filter effluent meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: | ||
| 20 L | 40 L | 60 L | |
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of: | ||
| 2 L | 4 L | 6 L | |
| Sterilization | May be autoclaved for 3 cycles of 60 minutes at 126 °C (cannot be steam sterilized in-line). | ||
| 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. | ||
| USP Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| 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). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| *Cage, end caps and capsule housing | |||
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
Sterile and Gamma Compatible Capsules
| Opticap® XL 3 Capsules | Opticap® XL 5 Capsules | Opticap® XL 10 Capsules | Per 10" Standard Area Opticap® XLT Capsule | Per 10" High Area Opticap® XLT Capsule** | |
| Nominal Dimensions | |||||
| Maximum length | 17.3 cm (6.8 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | 25.4 cm (10 in.) | 25.4 cm (10 in.) |
| Body diameter | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 10.7 cm (4.2 in.) | 6.9 cm (2.7 in.) | 6.9 cm (2.7 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 ) | 0.24 m2 (2.6 ft2 ) | 0.54 m2 (5.8 ft2 ) | 0.54 m2 (5.8 ft2 ) | 1.0 m2 (10.8 ft2 ) |
| Materials of Construction | |||||
| Filter membrane | Hydrophilic polyethersulfone | ||||
| Film Edge | Polyethylene | ||||
| Supports | Polyester | ||||
| Core | Polysulfone | Polyethersulfone | |||
| Structural components* | Gamma stable polypropylene | ||||
| Vent O-rings | Silicone | ||||
| Vent/Drain | 6 mm (¼ in.) hose barb with double O-ring seal | ||||
| Maximum Inlet Pressure | 6900 mbar (100 psi) intermittent at 23 °C 5500 mbar (80 psi) at 23 °C 2700 mbar (40 psi) at 60 °C 1000 mbar (15 psi) at 80 °C |
||||
| Maximum Differential Pressure | |||||
| Forward | 6900 mbar (100 psi) intermittent at 25 °C 5500 mbar (80 psi) at 25 °C 1000 mbar (15 psi) at 80 °C |
||||
| Reverse | 2100 mbar (30 psi) intermittent at 25 °C | ||||
| 70/30 IPA 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 bar (40 psi): | ||||
| ≤7.6 cc/min. | ≤14.0 cc/min. | ≤31.2 cc/min. | ≤31.2 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 | Gamma sterilized filter meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: | ||||
| 5.0 L | 9.5 L | 21 L | |||
| Oxidizable Substances | Effluent meets the USP Oxidizable Substance Test requirements for sterile purified water after a water flush of: | ||||
| < 2 L | 2 L | ||||
| Sterilization | |||||
| Gamma-compatible capsules | 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 | Sterile capsules may be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line). | ||||
| Sterility | |||||
| Sterile capsules | These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | ||||
| USP Toxicity | Non-toxic per MEM elution ISO® 10993-5 | ||||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||||
| 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 | |||||
| **Only available in gamma compatible capsules. | |||||
Sterile and Gamma Compatible Capsules
| Opticap® XL 150 | Opticap® XL 300 | Opticap® XL 600 | |
| Filtration Area | 140 cm² (0.155 ft²) | 290 cm² (0.316 ft²) | 590 cm² (0.631 ft²) |
| Materials of Construction | |||
| Filter Membrane | Polyethersulfone (PES) | ||
| Supports | Polyethylene | ||
| Structural Components* | Gamma stable polypropylene/Polysulfone | ||
| Vent O-ring | Silicone | ||
| Vent/Drain | 6 mm (¼ in.) hose barb with double O-ring seal | ||
| Maximum Differential Pressure | |||
| Forward: | 6900 mbar (100 psi) intermittent @ 25 °C; 5500 mbar (80 psi) @ 25 °C; 1000 mbar (15 psi) @ 80 °C. | ||
| Reverse: | 2100 mbar (30 psi) @ 25 °C, intermittent' | ||
| Bubble Point at 23 °C | ≥4000 mbar (58 psi) air with water | ||
| Air Diffusion at 23 °C | Through a water wet membrane at 2750 mbar (40 psi): | ||
| ≤1.0 cc/min. | ≤1.9 cc/min. | ≤3.7 cc/min. | |
| Bacterial Retention | Quantitative retention of 107 CFU/cm2 Brevundimonas diminuta (ATCC® 19146) per ASTM® F838-83 methodology | ||
| Bacterial Endotoxins | Aqueous extraction contains ≤0.25 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test. | ||
| TOC/Conductivity at 25 °C | Gamma sterilized filter effluent meets the WFI requirements of USP <643> for Total Organic Carbon and USP <645> for Water Conductivity after a WFI flush of: | ||
| 1 L | 2 L | 3 L | |
| Oxidizable Substances | Meets the USP Oxidizable Substances Test requirements for sterile purified water after a water flush of ≤1 L | ||
| Sterilization | |||
| Gamma-compatible capsules | 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 | Sterile capsules may be autoclaved for 3 cycles of 60 minutes at 123 °C (cannot be steam sterilized in-line). | ||
| Sterility | |||
| Sterile capsules | These capsules meet current USP and AAMI guidelines for sterility utilizing a validated sterilization cycle. | ||
| USP Cytotoxicity | Non-toxic per MEM elution ISO® 10993-5 | ||
| Good Manufacturing Practices | These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices. | ||
| Particle Shedding | Effluent meets the acceptance criteria set forth in USP <788> for large volume parenterals. | ||
| 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). | ||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182. | ||
| *Cage, end caps and capsule housing | |||
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