Oral solid dose medications
Vaccines
Medical aesthetics
Eye care
Central nervous system and gastroenterology products
Biochemicals and reagents
Crop protection products
Diagnostics
Medical Injection products
Veterinary medications
Horticultural propagation
Purified water
And more...
Increase process efficiency and ensure product quality by installing prefilters and bioburden control filters in key process steps. Prevent bacterial contamination in cell culture and fermentation tanks. Provide consistent fluid quality to protect vital downstream sterilizing and viral clearance filters.
Protect product quality and patient safety with filters that are strategically placed in upstream and downstream processes. These highly configurable filters remove particles and bacteria from raw ingredients and intermediates before reaching final filters to ensure a sterile product.
Product types (Life Sciences Product list)
Most Stringent and Critical Applications
High Protein Solutions with High Flow Rates
High Flow Rate and High Particle Load
Non-aqueous Liquids and Aggressive Solvents
Broad Chemical Compatibility
Case Studies
Improving Upstream Prefiltration and Converting Sterilizing Filters in New Process Design
Application Summaries
Filter Use for Bioburden Reduction and Sterilization in Drug Formulation and Filling
Sterilizing and Bioburden Reduction Filtration in Biopharmaceutical Processes
Prefiltration and Sterilizing Filtration of Plasma-Based Products
Filtration in the Preparation of Cell Culture Media and Buffers Used in Biopharmaceutical Operations
High Capacity
High Protein Solutions and Preservatives
Broad Chemical Compatibility
Case Studies
Optimizing Bioburden Reduction in an Enzyme Solution
Optimizing Bioburden Reduction Filtration in Saline Solutions
Application Summaries
Filter Use for Bioburden Reduction and Sterilization in Drug Formulation and Filling
Sterilizing and Bioburden Reduction Filtration in Biopharmaceutical Processes
High Proteins and Preservatives
High Flow Rate and High Contaminant Holding Capacity
Broad Chemical Compatibility
High Contaminant Holding and High Capacity
Critical Applications and High Retention
Broad Chemical Compatibility Prefilter
High Flow Rate and High Particle Load
Case Study
Solving a Mystery and Preventing Random Filter Fouling
Application Summaries
Prefiltration in Drug Formulation and Filling
Prefiltration and Sterilizing Filtration of Plasma-Based Products
Sterilizing for the Most Stringent Gas Filtration Applications
Sterilizing and High Flow Rates
Bioburden Control for Gas Filtration & Tank Vent
Application Summary
Tank Vent & Process Gas Filters for Pharmaceutical & Bioprocessing Production
Prefiltration that protects RO filters by removing particles, carbon fines and traps resins.
Bioburden control for WFI and bulk water to meet USP requirements.
Application Summary
Filtration for Pharmaceutical & Biopharmaceutical Water Systems
Remove bacteria debris and contaminants with sterilizing final filters that insure the final product.
Vent filters that protect purified water stored in tanks.
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 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.