Lifegard™ Cartridge Filters
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Overview
Specifications
Ordering Information
Documentation
FAQ
| Question | Answer | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| What are the flushing recommendations for prefilters? |
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Related Products & Applications
Product Families
OptiScale® Capsule Filters for Clarification and Prefiltration ApplicationsThese “drop-in” filter devices, with a variety of media options, create an effective platform for rapidly evaluating biopharmaceuticals.Learn More >> |
Lifegard™ Capsule FiltersOpticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.Learn More >> |
Related Products By: Application Facete
| Dialysis and Filtration |
Related Products By: Brand Facete
| Lifegard™ |
Categories
| Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Lifegard |
Description
Lifegard™ glass microfiber medium was designed for removal of deformable and non-deformable particles and microorganisms from liquids. Versatile depth-type products retain contaminants within the matrix of glass microfiber medium. The Lifegard™ media is used to achieve exceptional retention efficiency. Because of its high holding capacity, adsorptive removal properties and excellent wet strength, it is very well-suited for the clarification and prefiltration of serum, plasma proteins, gene therapy and other viscous biologicals.
Lifegard™ cartridge filters are ideally suited for processes that require maximum pressure differentials. Cartridges are robust, strong, resilient and are designed to withstand multiple steam-in-place cycles.
Regulatory Compliance
Filters with Lifegard™ media 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 for documentation accuracy. 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 your application requirements. A variety of connection options are offered for easy adaptation to existing housings.
The Filter of Choice in Plasma Proteins and Serum Applications
Lifegard™ filters protect downstream sterile filters and chromatography columns while effectively removing contaminants and retaining valuable fractions of interest. These filters will remove colloids, aggregated and non-product proteins, lipids and other particles before downstream purification.
| Per 10-inch Cartridge Filter | |
| Materials of Construction | |
| Filter Media | Borosilicate Glass Fiber (BGF) |
| Supports | Polypropylene |
| Structural Components | Polypropylene |
| O-rings | Silicone (SI) |
| Filtration Area | 0.46 m² |
| Maximum Differential Pressure, bar (psid) | 3.5 bar (50 psid) @ 25 °C |
| Bacterial Endotoxins | Aqueous extraction contains ≤1.0 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test |
| Gravimetric Extractables | The extractables level was equal to or less than 250 mg per 10-inch cartridge after 24 hours in water at controlled room temperature. |
| Oxidizable Substances | Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥5 L |
| 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. |
| Sterilization | 10 autoclave cycles or SIP @ 121 °C for 30 min |
| Sanitization | 30 min with hot water @ 80 °C |
| 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. |
Typical Clean Water Flow Rate vs Pressure Drop
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10-inch Cartridge Filters with Lifegard Media — 1.0 and 2.0 µm Nominal