Our filters are used in multiple locations to help meet the water quality requirements established by AAMI and USP for patient treatments and lab tests. Whether used alongside advanced treatment systems like reverse osmosis/deionization, or in water distribution lines, proper filtration ultimately protects patients.
Critical Process Filtration products remove particles and bacteria from chemicals and water used in medical device reprocessing. Filtration of makeup water, cleaning solutions, disinfectants, and rinse water utilized for device re-use ensures patient safety and meeting facility standards.
When filtration performance isn't meeting expectations, or you're developing a new process and a fresh perspective is needed, you can count on us to help troubleshoot and configure the best-fit solution for your operation.
With so many options to choose from, our experts provide advice that will help you "get it right the first time". Let's Talk.
Need a quick answer? With our complimentary service we will evaluate your issue and respond promptly. Tell us about your challenge.
Our technical services team can provide testing, analysis and validation services, as well as on-site support. Learn more.
Disc filters for lab work, mini-capsule filters for bench scale, standard capsules for pilot production through single-use, and cartridges for dedicated systems -- all are made using the same polymers and media for consistent performance.
Critical Process Filtration filters are designed for use in cGMP-compliant processes. Our state-of-the-art manufacturing facility and quality-management system both meet ISO 9001:2015 standards. Each operation from assembly and test to cleaning, drying, and packaging is done in appropriately rated clean rooms, and each filter is assigned a lot of code to ensure the traceability of manufacturing data and materials. A sophisticated MRP system collects and processes real-time data from manufacturing centers and inspection points.
The materials used to construct pharmaceutical-grade filters are non-toxic and meet the requirements for the MEM Elution Cytotoxicity Test and the requirements for Biological Reactivity Tests in the current version of the United States Pharmacopeia (USP) for Class VI - 121 °C Plastics. Critical Process Filtration filters comply with Title 21 CFR sections 210.3 (b)(6) and 211.72, for non-fiber-releasing filters. The levels of bacterial endotoxins in aqueous extracts from pharmaceutical-grade filters are below current USP limits as specified for water for injection.