Filtration in Medical Device Production

Optimizing filter performance at every stage of your process and at every scale from lab to full production.

Medical Device Production

We provide filtration solutions for processes in small to large scale production. Our filters remove particles and contaminants in cleaning solutions, disinfectants and rinse water.

Diagnostic Reagents & Standards

Makers of diagnostic reagents and standards rely on Critical Process Filtration filters to remove particles and organisms from the products to ensure reliable test results. 

Proven Solutions for Critical Filter Functions

Prefiltration

Removing particles and haze from ingredients, intermediates and final products.

Bioburden Control

Reduce the number of organisms in a stream. Protect downstream processes and critical sterilizing filters.

Sterilization

Filters validated to ASTM F838 for ≥ 7 log reduction of bacteria.

Vent & Gas

Prevent contamination of ingredients, intermediate fluids, water and final product while stored in tanks.

Don't go it alone. Our technical experts can help you find a solution among so many choices and variables.

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.

 

Purchasing New Filters

With so many options to choose from, our experts provide advice that will help you "get it right the first time".  Describe your requirements.

 

Have a Filtration Challenge

Need a quick answer? With our complimentary service we will evaluate your issue and respond promptly. Tell us about your challenge.

 

In Need of Technical Services

Our technical services team can provide testing, analysis and validation services, as well as on-site support. Learn more.

Multiple Filter Devices Made with the Same Media and Materials for All Scales

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.

 

Explore Medical Device Production Products

Quality Assurance and Standards

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 code to ensure the trace-ability of manufacturing data and materials. A sophisticated MRP system collects and processes real-time data from manufacturing centers and inspection points. 

USP Biosafety and FDA Compliance

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.

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