The fractionation process is based on the different solubility of the plasma proteins in relation to different conditions of some parameters, bath chemical end physical, like ethanol concentration, temperature, pH, ionie strenght. To get homogeneily in batches of plasma from thousands of donations and reduce the risk of virai transmission, before the definitive release for pockoging, plasma products always undergo several virus inactivation steps depending on the final product, such as:
· Heating of freeze dried products
· Detergenti solvent treatment
· Low pH
· Sterile filtration
Afterwards many different separation steps could follow one another:
· lon exchange chromatography
· Affinity chromatography
· Alcohol precipitation
· PEG precipitation
· Partitioning through filter press
Human Plasma is not only a /ife element of our body;
its the key element in immunedeficienciesand other diseases treatments.
The large part of plasma-derived products can only be treated from plasma,and plasma can only be extracted from human donors. Consequently, plasma is a finite resource that cannot be replicated or mass produced in large industriai process.
TECNinox has realized many plants for leading companies in plasma fractionation. Today, modern fractionation plants are large and complex. capable of fractionating millions of litres of plasma into a variety of therapeutic products. lhus, the plasma must be used efficiently by producing as many products as possible from each liter collected. lhe conditions under which take piace all plasma fractionation steps are very important;for example the temperature of buffer addition in precipitation tanks, the pH of suspension before each filtration or centrifugation, the optical density of permeate during the Albumin Ultrafiltration.
Furthennore, efficiency is also achieved by TECNinox system improving the most advanced manufacturing concepts for vessels and valve technology. The piping shall strictly comply with the capacity and heating and cooling system parameters, and the proper CIP/ SIP engineering has to be up to an organic materiai treatment plant in which the bacteria can grow very quickly.
Different plasma-derived products can be obtained from plasma fractionation
The whole Plasma Fractionation Plant that TECNinox can provide is the result of an engineered study based on a deep knowledge of the productive process acquired over the years working in close contact with customer, talking to production operators, understanding their needs and always sharing advanta-ges and potential problems.
An automatic or semi-automatic control system supervises each process recipe or maintenance phase; the system allows the customer to monitor and record all process parameter, both critical and not critical, it can guide the operator in each process operation and became a batch record visualised on the Operator Panel: user friendly and mistake proof are our key words.
Our strength is the competence and reliability largely feel by anyone who entrusts to us, right from the stage of basic design and process engineering.