Milligard® PES Filters
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개요
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Milligard® PES prefilters provide efficient particulate and bioburden reduction from different process streams. These versatile filters can be used throughout the bioprocessing workflow to increase the throughput capacity of sterilizing filters and improve process efficiency. They can also be used as an alternative to sterilizing filters for bioburden reduction in less critical applications.
Benefits:
- Fast flow and high throughput
- Validated bioburden reduction (1.2/0.2 μm nominal and 1.2/0.45 μm pore sizes only)
- Predictable scalability from small to production scale devices
- Stability: compatible with steam-in place, autoclave and gamma sterilization methods
- Available in our Mobius® single-use library
- Supported by the Emprove® Program
Available Pore Sizes
- 1.2/0.2 µm nominal
- 1.2/0.45 µm
- 1.2/0.8 µm
Available Formats
- OptiScale® 25 capsules – single-use, small-scale tools for process screening and scaling
- Cartridge filters - for pilot and production scale processing
- Opticap® XL and T-line capsules – for bench to production scale
Regulatory Compliance
Milligard® PES filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO 9001 Quality Systems Standard and are shipped with a Certificate of Quality. Each filter is supported by documentation to comply with regulatory requirements. For traceability and easy identification, each filter is marked with identifying characteristics.
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.
Mobius® Single-Use systems
Milligard® PES filters are part of our Mobius® library providing you with the flexibility to design single-use assemblies that meet your specific processing needs.
Learn more here
Specifications (OptiScale® Capsule and Cartridge Filters)
| Description | Optiscale® 25 Capsules | per 10-inch Cartridge |
| Nominal Dimensions | ||
| Diameter | 3.1 cm (1.21 in.) | 6.9 cm (2.7 in.) |
| Length 10 inch 20 inch 30 inch |
3.9 cm (1.52 in.) | 31.8 cm (12.5 in.) 56.3 cm (22.8 in.) 80.8 cm (31.8 in.) |
| Approximate Filtration Area | 3.5 cm2 | |
| 1.2/0.2 μm nominal (m2/ft2) | - | 0.60 m2 (6.5 ft2) |
| 1.2/0.45 μm (m2/ft2) | - | 0.60 m2 (6.5 ft2) |
| 1.2/0.8 μm (m2/ft2) | - | 0.53 m2 (5.7 ft2) |
| Materials of Construction | ||
| Membrane | Hydrophilic polyethersulfone | |
| Filter Supports | Polypropylene | |
| Cage, Core, End-caps | - | Polypropylene |
| O-ring | - | Silicone |
| Vent Cap | Polypropylene | |
| Housing Vent | Capped vent with female Luer connection on inlet side of device | - |
| Maximum Inlet Pressure | 4.1 bar (60 psi) at 25 oC | - |
| Maximum Differential Pressure | ||
| Forward | 4.1 bar (60 psi) at 25 oC | 5.5 bar (80 psi) at 4-25oC 1.7 bar (25 psi) at 80 oC 0.3 bar (4 psi) at 135oC |
| Reverse | 0 bar | 1.4 bar (20 psi) at 4-25 oC 0.07 bar (1 psi) at 135oC |
| Bubble Point at 25 oC | ||
| 1.2/0.2 μm Nominal | - | ≥ 2700 mbar (39.2 psi) air with water |
| 1.2/0.45 μm | - | ≥ 2290 mbar (33.3 psi) air with water |
| 1.2/0.8 μm | - | ≥ 990 mbar (14.3 psi) air with water |
| Bioburden Reduction | - | The 1.2/0.2 μm nominal filter typically provides ≥6 log removal of Brevundimonas diminuta based on ASTM® F838 methodology. The 1.2/0.45 μm filter typically provides ≥6 log removal of Serratia marcescens based on ASTM® D3863 and F838 methodology. |
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01. | |
| TOC/Conductivity at 25 oC | This product exhibits less than 500 ppb TOC per USP <643> and less than 1.3 μS/cm at 25 oC per USP <645> after autoclaving and purified water flush of 15 mL. | After sterilization and a controlled water flush of 20 L per 10-inch device, sample exhibited ≤500 ppb TOC per USP <643> and ≤1.3 μS/cm per USP <645> at 25 oC. |
| Sterilization | May be autoclaved for 1 cycle at 123 oC for 60 min. | Device integrity was maintained after 25 autoclave cycles of 60 minutes at 128oC. Device integrity was maintained after in-line steam of 10 forward and5 reverse cycles of 30 minutes at 135 oC. |
| Non-Fiber Releasing | Devices tested and meet requirements of USP <788> for large volume parenterals. | |
| Toxicity | Component materials meet the criteria for Class VI testing based on USP <88> Biological reactivity, in vivo. This product meets the specifications of ISO 10993-5 tests for in vitro cytotoxicity and USP <87> Biological Reactivity, in vitro. |
|
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182 based on information provided by raw material suppliers. | |
| Quality Management System | This product was manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Management Systems Standard. | |
Specifications (Gamma-compatible Capsule Filters)
| Opticap® Small Scale 300 Capsules | Opticap® XL Capsules | Opticap® T-line Capsules | ||||
| 5 inch | 10 inch | 10-inch | 20-inch | 30-inch | ||
| Nominal Dimensions | ||||||
| Diameter | 6.4 cm (2.5 in.) | 10.7 cm (4.2 in.) | 8.9 cm (3.5 in.) | |||
| Length | 12.9 cm (5.1 in.) | 21.6 cm (8.5 in.) | 33.5 cm (13.2 in.) | 34.8 cm (13.7 in.) | 58.6 cm (23.1 in.) | 83.9cm (32.6 in.) |
| Approximate Filtration Area | ||||||
| 1.2/0.2 μm nominal (m2/ft2) | 0.032 m2 (0.34 ft2) | 0.31 m2 (3.3 ft2) | 0.60 m2 (6.4 ft2) | 0.60 m2 (6.4 ft2) | 1.20 m2 (12.8 ft2) | 1.80 m2 (19.4 ft2) |
| 1.2/0.45 μm(m2/ft2) | 0.031 m2 (0.33 ft2) | 0.31 m2 (3.3 ft2) | 0.59 m2 (6.4 ft2) | 0.60 m2 (6.4 ft2) | 1.20 m2 (12.8 ft2) | 1.80 m2 (19.4 ft2) |
| 1.2/0.8 μm(m2/ft2) | 0.032 m2 (0.34 ft2) | 0.28 m2 (3.0 ft2) | 0.53 m2 (5.7 ft2) | 0.57 m2 (6.1ft2) | 1.15 m2 (12.4 ft2) | 1.73 m2 (18.6 ft2) |
| Materials of Construction | ||||||
| Membrane | Polyethersulfone | |||||
| Filter Supports | Polyethylene terephthalate | |||||
| Cage, Core, End-caps | Gamma-stable polypropylene | |||||
| Capsule Housing | Gamma-stable polypropylene | |||||
| Vent O-ring | Silicone | - | ||||
| Vent/Drain | ¼ in. hose barb with double O-ring seal; Connects to 1/8 in. tubing | - | ||||
| Maximum Inlet Pressure | 5.5 bar (80 psi) at 25 oC | 4.5 bar (65 psi) at 25 oC | ||||
| Maximum Differential Pressure | ||||||
| Forward | 5.5 bar (80 psi) at 4-25 oC 1.7 bar (25 psi) at 80 oC |
4.5 bar (65 psi) at 4-25 oC 1.7 bar (25 psi) at 80 oC |
||||
| Reverse | 1.4 bar (20 psi) at 4-25 oC | |||||
| Bubble Point at 25 oC | ||||||
| 1.2/0.2 μm nominal | ≥ 2700 mbar (39.2 psi) air with water | |||||
| 1.2/0.45 μm | ≥ 2290 mbar (33.3 psi) air with water | |||||
| 1.2/0.8 μm | ≥ 990 mbar (14.3 psi) air with water | |||||
| Bioburden Reduction | The 1.2/0.2 μm nominal filter typically provides ≥6 log removal of Brevundimonas diminuta based on ASTM F838 methodology. The 1.2/0.45 μm filter typically provides ≥6 log removal of Serratia marcescens based on ASTM D3863 and F838 methodology. |
|||||
| Bacterial Endotoxin | Aqueous extraction contains <0.25 EU/mL per device as determined using the Limulus Amebocyte Lysate (LAL) test, meeting requirements of USP <85>, EP 2.6.14 and JP 4.01. | |||||
| TOC/Conductivity at 25 oC | After sterilization and a controlled water flush of 20 L per 10-inch device, sample exhibited ≤500 ppb TOC per USP <643> and ≤1.3 μS/cm per USP <645> at 25 oC. | |||||
| Sterilization | Device integrity was maintained after gamma irradiation up to 40 kGy and 3 wet autoclave cycles of 60 minutes at 123 oC. | |||||
| Non-Fiber Releasing | Devices tested and meet requirements of USP <788> for large volume parenterals. | |||||
| Toxicity | Component materials meet the criteria for Class VI testing based on USP <88> Biological Reactivity, in vivo. This product meets the specifications of ISO 10993-5 Tests for in vitro cytotoxicity and USP <87> Biological Reactivity, in vitro. |
|||||
| Indirect Food Additive | All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177–182 based on information provided by raw material suppliers. | |||||
| Quality Management System | This product was manufactured in a facility whose Quality Management System is approved by an accredited registering body to the appropriate ISO 9001 Quality Management Systems Standard. | |||||
