With GEA separator hycon and the 3-room concept, GEA is way ahead in the field of fully automated production in cleanroom applications
With GEA separator hycon and the 3-room concept, GEA is way ahead in the field of fully automated production in cleanroom applications. (Photo: GEA)
For the separation of blood plasma and plasma proteins, GEA offers an optimal solution with the fully automatic clarifier hycon. The GEA separator hycon enables "one-touch production". With this separator technology, GEA is a pioneer in the field of fully automated production in clean room applications.
The centrifuge is self-cleaning and has a customer-specific solids tank. The separated solids can be collected in a bag, for example, which is placed in this container. This closed process replaces the conventional manual emptying of the separator bowl. The advantages of closed handling are significantly better hygiene conditions and, as a result, better sterilizability, prevention of cross-contamination, greater batch safety and improved Good Manufacturing Practice (GMP) documentation. Cleaning-In-Place (CIP) and Sterilize-In-Place (SIP) were previously not even possible with chamber machines.
Another decisive plus is the reduced downtimes that were incurred by emptying the chamber machines by hand. Maintenance work on the separator is also noticeably reduced by the technical solution of the "hanging bowl". The hycon thus contributes to GMP-compliant work and thus to quality assurance of the production processes and environment in pharmaceutical production.
Plasma proteins is a collective term for the blood proteins most commonly found in blood plasma. Plasma proteins perform numerous tasks in blood plasma. These include maintaining colloid osmotic pressure and blood pH (buffer function) and transporting (specific and nonspecific carriers) water-insoluble substances, hormones, and enzymes.
Fractionation of human blood plasma provides purified and concentrated proteins from which drugs for intensive care and emergency medicine and against rare diseases are produced. New drugs made from immunoglobulins extracted from the blood of people who have survived corona disease are under development and are expected to be applicable to severe corona. The process of blood plasma fractionation is complex and requires in-depth knowledge of both the process and the specific equipment to achieve high yields in a cost-effective time frame.
Traditionally, conventional chamber centrifuges handle the fractionation of plasma using the ethanolic Cohn process. These GEA centrifuges, like the new GEA hycon, can be cooled within a narrow temperature range necessary for process control. With this design, the particularly valuable solid material with a value of up to several hundred thousand euros per drum filling must be removed by lifting out the drum as a complete unit after removing the residual liquid and scraping out the contents by hand in a special clean room. The chamber separator must then be cleaned manually. Sterilization is not possible. The pharmaceutical industry wanted this relatively complex process to be simplified.
GEA's hycon fully automatic clarifier is an optimal solution for the separation of blood plasma and plasma proteins. (Photo: GEA)
With the hycon®, GEA has developed a concept that allows the use of a self-cleaning, fully automatic separator, combined with a consistent separation of mechanical components, i.e. motor and drive, and the area in contact with the product. In this completely enclosed three-room concept, the suspended bowl with hood and solids trap is located in a clean room mounted below the separator frame, while the drive units are located in a lower-classified room above. The operating elements are also located outside and thus emission-free for the high-clean room in the adjacent room. The very valuable solids are discharged fully automatically from the suspended separator bowl at reduced or full operating speed under sterile conditions.
The hermetic separation of the drive located at the top and the bowl located at the bottom makes it possible to build a much smaller and thus also more cost-effective cleanroom for the product-carrying bowl. Sterility of the process is ensured by steam sterilizability (SIP). Fully automatic Cleaning-In-Place (CIP) eliminates the need for manual cleaning and ensures the required hygiene in accordance with GMP (Good Manufacturing Practice) and thus the highest product quality. The three-room concept enables continuous operation, while chamber separators require pure batch operation. Depending on the product, self-cleaning can also take place at low speed, making it extremely gentle. In addition, the integrated hermetic feed enables slow, gentle acceleration of the product, which is gentle on the product. Cooling is also a matter of course with the hycon. The three-room concept with the hycon® hyperconcentrator can also be used for other sterile processes with high added value, for example in the production of insulin.
GEA is a partner to virtually all major global blood plasma manufacturers. Separation technology with separators is one of the key technologies in blood plasma fractionation. GEA also offers complete systems and process lines for blood plasma and vaccine production.