Filtration Solutions for Pharmaceutical Formulation & Filling

Sterilizing

Sterilizing insurance. Our PPS Filters are recommended for the most stringent and critical applications to ensure 100% bacteria retention. This filter’s media consists of two identical hydrophilic membranes. Pore sizes range from 0.03 to 1.2 µm.

Targeted bacteria retention.  DPPS filters deliver custom bacteria retention based on your fluid load. You choose the pore sizes of both the prefilter and final layer to achieve targeted results. The prefilter acts as both a bioburden reduction and particle-removing filter.

Sterilizing fluids with high particle loads. CPF’s HPPS Filters handle increased capacity and high particle loads with an integrated prefilter for particle removal and a sterilizing final filter. This dual-layer model reduces two filtration steps into one.

Sterilizing & endotoxin removal. The PPC Filter consists of a double-layer sterilizing membrane for stringent bacteria retention, and it has been positively charged to remove any gram-negative bacteria debris. 

Bioburden Reduction

Bioburden reduction, non-sterilizing. BPS Filters reduce microbial in aqueous liquids when sterilizing is not required. These hydrophilic filters are available in single and dual-layer configurations with a choice of pore sizes for each layer to provide the right level of retention.

Mycoplasma

Mycoplasma control.  When your goal is mycoplasma reduction, all CPF sterilizing filters rated at 0.10 microns will reliably reduce mycoplasma in your fluids. When validation of  >log 7  removal is required, choose any CPF sterilizing filter rated at 0.03 microns.

Tank Vent & Process Gas Filtration

Protecting tank contents and the environment. CPF's PTR Filters are hydrophobic sterilizing filters made with  Polytetrafluoroethylene (PTFE) membrane to capture microbial as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators and the environment in the surrounding workspace.

Clarification & Prefiltration

Clarifying and prefiltering microbial and particulates found in pharmaceutical ingredients and excipients will reduce the contamination load on the final filter. In processing applications where the sterile product is critical and final filters carry the greatest cost, CPF prefilters do the bulk of filtration, resulting in:

• fewer changeouts
• extending the life of your sterilizing filters
• lower overall filtration costs

High particle loads. BCWPS Filters, made from CPF's proprietary high-capacity PES membrane, excel in protecting downstream filters. With its low binding characteristics, BCWPS filters are used for the clarification and prefiltration of products with high proteins and preservatives. Membrane prefilters, such as the BCWPS offer greater retention than a depth filter.

High flow and particle removal. Our PGD Prefilters are made with pleated fiberglass depth media and have a high contaminant holding capacity while still delivering high flow rates.  

Fine particles in water, solvents, and chemicals. PPD Prefilters, constructed with pleated polypropylene depth media, are versatile filters offering broad chemical compatibility and high retention of fine particles in a variety of fluids used in pharmaceutical applications.

The heavy solids content and contamination. CPF's HLP Prefilters, constructed with high-loft pleated polypropylene depth media, combine superior filtration capacity with exacting retention of fine particles.

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 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. 

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.