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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.
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Lifegard™ Capsule FiltersOpticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
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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.
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)|
|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.|