StarCaps Capsule Filters are self-contained ready-to-use capsule filters. Available in varying sizes and filters media including depth filters, liquid sterile-grade filters and gas filters, they were developed to meet a wide range of pharmaceutical filtration requirements from R&D to Production.
StarCaps Capsule Filter Series eliminates cleaning validation requirements when compared to the traditional filter cartridge and housing combination.
Features and Benefits
- Can be used from R&D to Production
- Available in varying filter medias depending on application requirements
- Disposable filter design reduces cleaning and maintenance cost
- Thermally bonded with no adhesives or glues
- Sanitary flange and hose barb connections provide clean and easy connection
- Manufactured in a facility which adheres to ISO 9001:2015 Practices.
- Full Regulatory Compliance with following :
• Bacterial Endotoxin :Aqueous extraction of autocalved filter contains <0.25 EU/ml as determined by Limulus Amebcyte Lysate (LAL),USP<85>.
• Non-fiber Releasing :Component materials meet the criteria for a “Non-fiber-releasing filter” as defined in 21 CFR 210.3(b)(6).
• Component Material Toxicity :Meet the requirement of USP <87> In Vitro Cytotoxicity Test; Meet the Criteria of USP<88> Biological Reactivity Test for Class VI-121℃ plastics
• TOC/Conductivity at 25 ℃：Autoclaved filter effluent meet the USP<643> for Total Organic Carbon and USP<645> for Water Conductivity per WFI requirements after a UPW flush of specified volume.
• Particle Shedding: Autoclaved filter effluent meet the USP<788>for large volume Injections.
•I ndirect Food Additive：All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182, and EU framework regulation [1935/2004/EC].
- Biological Fluids
- Buffer Solutions
- Cleaning and Disinfecting Solutions
- Injectable Solutions
- Gas Filtration
Max. Continuous Operating Temperature: 40°C
Max. Differential Pressure: 5bar / 20°C (forward)