Serum Filtration and Plasma Filtration

Critical Process Filtration can assure product purity with our quality serum and plasma filters that retain bacteria, mycoplasma, endotoxins, and other unwanted contaminants. These filters are specifically manufactured to process the highest quality human and animal serum and plasma.

Designed by our engineers to meet industry standards and optimized by application, Critical Process Filtration's proven serum and plasma filters deliver the quality you require. We start with a prefiltration step which helps lower your overall costs and protects your sterilizing filters. It is imperative that you install the correct train of prefilters and sterilizing filters based on the blood’s makeup, characteristics, and bacteria load.

Critical Process Filtration Serum & Plasma FiltersThe expert team at Critical Process Filtration can help ensure that you order the equipment you need to perform the specific processes for your business. From us, you will always receive quality filters manufactured in the USA that ship in weeks, not months, to keep your business running as scheduled. 

cropped serum dark gray gradient backgroundWhen processing the highest quality animal and human serum/plasma products, CPF sterile filters are an excellent choice.



The key to effective contaminant retention and lowering your overall filtration costs is to strategically incorporate prefilters that protect expensive sterilizing filters.

Made from CPF's proprietary high capacity PES membrane, BCWPS Filters 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 based prefilters, such as the BCWPS offer greater retention than a depth filter.

HLP Prefilters, designed for processes with a heavy particle load requiring high throughput, are made using high-loft polypropylene depth media.

For excellent retention at high flow rates and a high contaminant holding capacity, PGD Filters made with fiberglass media perform exceptionally well.  Fiberglass is a an effective media for serum filtration and Critical Process can customize the number of fiberglass layers needed to meet your performance requirements.

Installing the right train of prefilters and sterilizing filters based on the blood component's characteristics and bacteria load will assure product sterility before quality control testing.

Sterilizing & Endotoxin Removal

PPS Filters, constructed with a double layer of Polyethersulfone (PES) will meet your requirement to remove all bacteria with a 0.22 or 0.10 micron configuration.  If higher flow rates are driving your decision, SPS Filters made with a single layer of PES is your better choice. When starting with a less refined product, HPPS Filters with an integrated prefilter will increase capacity and sterilize your fluids without requiring another filter. 

Where mycoplasma is an issue, CPF recommends 0.03 micron filters for capturing small deformable particles that might penetrate through a traditional 0.2 micron filter. Use of 0.03 micron filters in a validated process ensures sterile, mycoplasma-free serum and plasma.  

When keeping endotoxins out of your process is required, they can be eliminated with either of our positively charged endotoxin removal filters. For both sterilization and removing endotoxin, PPC Filters, made with a double layer of PES, are validated for absolute bacteria retention and also capture negatively charged debris. Depending on level of contaminant and flow rate, PPC filters will typically exhibit > 3-log removal of endotoxin.

If you are already using a sterilizing filter, our general purpose GPC Filter, made from a single layer of PES, will capture negatively charged biological contaminants such as endotoxins and other cell fragments in aqueous fluids.

Protecting tank contents and the process environment

CPF's PTR Filters can prevent environmental and process gas sources of bacteria and contaminants. These hydrophobic sterilizing filters are made with Polytetrafluoroethylene (PTFE) membrane to capture microbials as air/gas enters a tank. Likewise, as air/gas is released from the tank, the PTR filter protects operators in the surrounding work space.

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 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.