Serum/Plasma Filtration

Assure product purity with quality filters that remove bacteria, mycoplasma, endotoxins, and other unwanted contaminants.

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New! Endotoxin Filters

Introducing the newest additions to our bacteria removal product suite - the GPC and PPC filters. These PES membrane filters are positively charged to retain gram-negative bacterial cell debris.

 

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

 


Prefiltration

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.