|What are the flushing recommendations for prefilters?||
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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Opticap XL Disposable Capsule Filters with Lifegard MediaOpticap XL capsule filters eliminate the time and expense associated with assembling, cleaning, and validating stainless steel housings.
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|Biopharmaceutical Manufacturing > Downstream Processing > Bioburden Reduction/Particulate Control > Membrane based > Lifegard|
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.|