Polygard-CR Cartridge Filters
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| Biopharmaceutical Manufacturing > Downstream Processing > Clarification > Clarisolve Depth Filters > Polygard Filters |
Description
Polygard®-CR products are nominally rated filters designed for particle removal applications in liquids and gases. The graded-density depth structure of Polygard-CR filter media provides maximum filtration capacity, and the all-polypropylene construction offers low extractables levels and broad chemical compatibility.
Polygard-CR cartridge filters provide high throughput with minimal differential pressure. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
Typical Applications
Polygard-CR high-efficiency cartridge filters, composed of graded density polypropylene media are widely used in the beverage industry for liquid and gas filtration applications to protect tighter filters.
Regulatory Compliance
Polygard-CR filters are designed, developed, and manufactured in accordance with a Quality Management System approved by an accredited registering body to an ISO® 9000 Quality Systems Standard and are shipped with a Certificate of Quality. Each cartridge filter is supported by a Validation Guide for compliance with regulatory requirements.
For traceability and easy identification, each filter is marked with identifying characteristics.
Multiple Formats Available
A full range of filtration areas is available to suit varying application requirements. A variety of connection options are offered for easy adaptation to existing housings. The small scale filter capsules are available as a selection tool when evaluating several media configurations for use in clarifying process fluids. These devices have been developed to minimize hold-up volume when evaluating multiple media configurations.
| Per 10-inch Cartridge | ||
| Materials of Construction | ||
| Filter medium | Polypropylene (PP) | |
| Structural components | Polypropylene | |
| O-rings | Silicone (SI) | |
| Code F gaskets | Polyethylene (PE) | |
| Maximum Differential Pressure, bar (psid) | 4.8 bar (70 psid) @ 25 °C | |
| Gravimetric Extractables | ≤50 mg after 24-h soak in water | |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L | |
| Bacterial Endotoxins | Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test | |
| Sterilization | ||
| Code 0, Code 5, Code 7, Code M | 10 autoclave cycles or SIP @ 126 °C for 30 min | |
| Code F | 10 autoclave cycles or SIP @ 126 °C for 30 min | |
| Sanitization | 30 min with hot water @ 80 °C | |
| Component Material Toxicity | Component materials meet the criteria of the USP <88> Reactivity Test for Class VI Plastics. These products 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. | |
Typical Clean Water Flow Rate vs Pressure Drop
Cartridge Legends Refer to Pore Size (nominal):
CRK1 = 0.1 µm
CRK3 = 0.3 µm
CRA5 = 0.5 µm
CR01 = 1.0 µm
CR03 = 3.0 µm
CR05 = 5.0 µm
CR10 = 10.0 µm
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10-inch Cartridge Filters with Polygard-CR Media