Blood products are a general term for the plasma protein components prepared from healthy human plasma or specifically immunized human plasma through separation and purification, as well as the formed components of blood cells. At present, most blood product companies use the low-temperature ethanol method to separate plasma components. The use of depth filter is an indispensable method in the separation process. Depth filter can separate and collect components in the plasma which is an important part of the supply chain.
Composition of Blood
The composition of human blood is shown in the figure. The function of blood includes blood cell function and plasma function. It has the functions of transportation, regulation of body temperature, defense, regulation of human osmotic pressure and acid-base balance.
Feature 1. The composition of human blood
DEBL Series Depth Filter
Cobetter Roheap® CSD DEBL series depth filter is compounded by high-purity cellulose and inorganic filter aids through a special process. Its internal crisscross three-dimensional space structure makes it a deep filter medium, providing excellent filtration efficiency, high dirt-holding capacity, and characterized by very low levels of extractables, metal leachables, and endotoxins. Blood product companies can use depth filter with different ratings for different applications. Cobetter can provide 8 types of ratings for selection, and DEBL50 is widely used.
CEBL Series Depth Filter
CEBL series depth filter is made of high-purity lignocellulose, free of mineral components, and feature lower extractables, metal leachables and endotoxins. We recommend CEBL series filter plates for those process points where each component product is close to the back end, 8 types of ratings are also available for selection, and CEBLS4 is currently widely used.
Depth Filter Features
The product technical data of DEBL series and CEBL series are as follows:
Feature 2. Technical data of DEBL series and CEBL series
The production process of each blood product company can be different, but the low-temperature ethanol method is mainly used for separation. The depth filter specially developed by Cobetter for the separation of blood product components has mature applications. The process of plasma protein products and model recommendations are shown in the figure below.
Feature 3. The process of plasma protein products and model recommendations
Extractables and Leachables
Using DEBL50 depth filter containing diatomite in conventional component separation can increase the filtration capacity and maintain a high filtration rate; in component separation, use CEBLS4 depth filter without diatomite earth to control metal ions precipitation.
Taking CSDDEBL50 and CSDCEBLS4 as examples, depth filter for blood products has a lower aluminum ion content (ppb level), and the precipitation content of 12 metal ions under different flow rate of purified water and 40% ethanol are shown in below tables:
Feature 4. Metal ion content under different flow rate through CSDDEBL50
Feature 5. Metal ion content under different flow rate through CSDCEBLS4
We conducted relevant tests based on the chemical solvents commonly used by blood product companies, and tested the chemical compatibility at room temperature and high temperature of 80°C. It is safer to use at low temperature.
Feature 6. The chemical compatibility at 20°C and 80°C
Cobetter can provide blood product customers with customized services and different sizes and shapes of depth filters. At present, Cobetter depth filters have been tested on different products of 10 domestic blood manufacturers including 4 leading companies’ pilot or commercial production.
Cobetter invested 16 million USD to build an 80m-long continuous depth filter production line for blood product applications, covering an area of 1,500 square meters. The depth filters are produced in a Class 100,000 cleanroom, the suspended particles, temperature, humidity, pressure difference, and settling microbe are strictly managed. Cobetter is actively building ecological manufacturing, strengthen the hardware and software construction towards a modern depth filter factory to serve our pharmaceutical customers all over the world.