3M™ LifeASSURE™ PDA Series Filter Cartridge
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Details
Highlights
- Validated 0.2 and 0.1 micron rated membrane provides reliable sterilizing filtration
- Excellent contaminant capacity, flow rates, and life resulting from robust double-asymmetric membrane layer filter construction
- Hydrophilic asymmetric polyethersulfone membrane enables wet out in aqueous solutions for integrity testing
- Advanced Pleat Technology construction increases the useful surface area by increasing the flow paths between media pleats
- 100% forward flow Integrity tested prior to release
- 21 CFR compliant materials of construction and other documentation supports validation and regulatory submissions
We combine two asymmetric polyethersulfone (PES) membrane layers with Advanced Pleat Technology in manufacturing LifeASSURE™ PDA Series Filter Cartridges, creating a filter that provides high throughput and fast flow. These filters have applications in pre-filtration and sterilizing filtration in the pharmaceutical, biological, and bioprocess industries where low protein binding is critical
Membrane Know-how
As we manufacture LifeASSURE™ PDA Series cartridge filters, we incorporate two layers of polyethersulfone membrane. The highly asymmetric upstream layer provides prefiltration capacity for the downstream layer, which is also asymmetric. Together, the membrane layers create a gradient membrane pore morphology that provides relatively high contaminant capacity and fast flow rates in a sterilizing grade membrane filter.
Advanced Pleat Technology Design
LifeASSURE™ PDA Series cartridge filters also feature our innovative Advanced Pleat Technology construction that helps extend service life. This design technology is intended to increase the useful surface area while maintaining open flow paths between media pleats.
Transforming Your Science to Life
LifeASSURE™ PDA filters meet 0.2 and 0.1 Μm rated filtration requirements for critical sterilization applications, such as:
- Biologicals
- Orals and topicals
- Vaccines
- Parenterals (SVP, LVP)
- Ophthalmics
- Final 0.1 and 0.2 Μm sterilizing filtration
- Chromatography column protection
- Serum and blood fractions
- Solvent filtration
- Bulk pharmaceutical chemicals
- Media and fermenter feed streams
- Cell culture fluids
- High protein feed streams
- Reagents and Buffers
- High purity DI water and WFI systems
We manufacture LifeASSURE™ PDA Series filter cartridges using all-polypropylene structural components (end caps, adapters, media support, inner core and outer cage). We offer LifeASSURE™ PDA filter cartridges in multiple lengths to match the dimension and sealing requirements for most cartridge housings currently available.
Engineered for Quality and Reliability
Our Quality Management System is approved by an accredited registering body to the ISO 9001:2008 and ISO 13485:2003 Quality Management Systems, and the cartridges are 100% forward flow integrity tested prior to shipment. We ship all LifeASSURE™ PDA cartridge and capsule filters with a Certificate of Quality affirming compliance with manufacturing quality specifications. Additionally, supporting Drug Master File (DMF) documentation is on file with the United States Food and Drug Administration (FDA) and a complete LifeASSURE PDA Validation Guide is available upon request.
Meeting Your Scale-Up Needs
We are pleased to offer a full range of LifeASSURE™ PDA sterilizing-grade filters to meet your scale-up process needs. This includes pre-sterilized or sterilizable disposable capsules in various sizes as well as full-size cartridges. We also offer filter discs and 50 mm capsules when even smaller membrane surface areas are required.
Specifications
