BLOOD PLASMA FRACTIONATION
Background
Blood plasma is the liquid part of blood and makes up around 55 % of the total blood volume. Even though blood plasma primarily consists of water, it contains proteins such as albumin, immunoglobulins and clotting proteins (e. g. fibrinogen). These proteins are of great importance for therapeutic uses and therefore, highly valuable. To obtain plasma proteins, blood plasma is collected and typically fractionated. The plasma fractionation process consists of numerous steps with changing ethanol concentration, pH and temperature levels. By changing the conditions, certain proteins are precipitated out of the solution and removed. The final products are purified plasma proteins for injection or transfusion.
The challenge
Depth filtration is a well-established and efficient technology for separating blood plasma proteins. The extremely valuable starting material requires carefully chosen production conditions to ensure optimal recovery of both, solids and liquids during the numerous steps to separate precipitated proteins. Furthermore, extractables from filter media including beta-glucans, metal ions and pyrogens, are of concern for manufacturing pharmaceutical products and need to be reduced to a minimum.
The solution
FILTROX offers filtration systems for different steps in the plasma fractionation process, such as separation of precipitate, clarification or decolorization. The product range includes filter systems specifically designed for plasma fractionation to ensure economical manufacturing with minimal product loss and lowest levels of extractables.
Depth Filtration Steps
The process of plasma fractionation is very complex and involves numerous processing and filtration steps. Our depth filtration solutions are mainly used for the separation of precipitates and clarification in the IVIG and albumin manufacturing process.
Product Range
| Product | Size | Description | Best use |
| PURAFIX® PF | Various sheet sizes | Low beta-glucans and endotoxins, low ions, specifically designed for plasma fractionation |
Separation of precipitate, coarse/clarifying filtration, sterile filtration |
| PURAFIX® CH PURADISC® CH |
Various sheet sizes 12″ & 16″ Module |
Low levels of extractable endotoxins and ions | Separation of precipitate, coarse filtration and fine filtration |
| PURAFIX® ZP | Various sheet sizes | Depth filter sheet with a positive zeta-potential, for germ-reducing and sterilizing filtration |
Coarse, fine and sterile filtration |
| ACTIVASORB® CA ACTIVADISC® CA |
Various sheet sizes 12″ & 16″ Module |
Contains immobilized activated carbon | Decolorization |
| ACTIVASORB® PR ACTIVADISC® PR |
Various sheet sizes 12″ & 16″ Module |
Contains immobilized activated carbon | PKA removal |
PURAFIX® CH depth filter media is also available as capsules (2″, 5″ & 10″) for lab and pilot scale filtrations.
Filter Media
Separation of Precipitate and Clarification
PURAFIX® PF – Low beta-glucan depth filter sheets
The PURAFIX® PF filter sheet series combines high purity with excellent application properties for critical filtrations such as blood plasma fractionation. Each grade has been specially formulated for different applications in the manufacturing process.
PURAFIX® PF filter sheets are produced from specially selected raw materials to ensure lowest levels of extractables such as metal ions, endotoxins (< 0.06 EU/mL) and beta-glucans (< 100 pg/mL).
PURAFIX® CH and ZP – Highly pure depth filter sheets for pharmaceutical filtrations
PURAFIX® CH filter sheets are very low in extractables such as metal ions and pyrogens. Therefore, they are ideally suited for processing pharmaceutical products. PURAFIX® ZP depth filter sheets are characterized by a positive zeta potential. Thus, this filter sheet series is used for challenging applications that require the removal of negatively charged particles.
PURAFIX® filter sheets are also available as PURADISC® lenticular filter modules, which allow easy handling of large filter areas in a simple manner and as single-use option PURADISC® BIO SD for alluvial filtration.
Decolorization and PKA Removal
ACTIVASORB® – Depth filter sheets with immobilized activated carbon
ACTIVASORB® products are depth filter sheets made of purified cellulose and activated carbon. Treatment with immobilized activated carbon is much more efficient compared to loose carbon powder due to a forced contact of the impurities with the activated carbon. Therefore, contact times can be reduced and a secondary filtration step is eliminated, resulting in a more efficient and clean production process.
ACTIVASORB® filter sheets are also available as ACTIVADISC® lenticular filter modules, which allow easy handling of large filter areas in a simple manner.
Easy handling and high efficiency
Various PURAFIX® depth filter sheets are available for the different requirements in the plasma fractionation process to ensure high efficiency with minimal product loss. Furthermore, ACTIVASORB® filter sheets with activated carbon are easy to handle and highly effective due to the forced contact of the impurities with the activated carbon.
Lowest levels of extractables
PURAFIX® PF depth filter sheets are highly pure and low in extractable beta-glucans and endotoxins, making them the perfect fit for applications within the plasma fractionation process.
Closed systems with no drip loss
Our filtration solutions are closed filtration systems that allow easy handling with minimal cleaning effort.
Related Products
Filter Media
 |  | |  | |||
| PURAFIX® Filter sheets | PURADISC® Filter modules | ACTIVASORB® Filter sheets | ACTIVADISC® Filter modules |
Downloads
►Brochure Blood Plasma Fractionation►Technical Data Sheet PURAFIX® PF Filter Sheets
►Technical Data Sheet PURAFIX® CH Filter sheets
►Technical Data Sheet PURADISC® Modules
►Technical Data Sheet PURAFIX® ZP Filter sheets
►Technical Data Sheet ACTIVADISC® Modules
►Technical Data Sheet ACTIVASORB® Filter sheets
