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Design and construction of a GMP microfiltration for parenterals
Starting point: process development of a time saving microfiltration process by us.
customer need: GMP membrane unit for production of parentreal product for clinical trials, fitting to existing infrastructure
Activities PS: desing, construction, installation, start-up and training of personell. Membrane unit with demanding specifications concenring surface finish, accurate controll documentation
Result: unit installed and qualified
Extraction solution recycling in a pharma production
Problem: big amounts of solvent extraktion waste (by-products dissolved in Methanol/Water had to be incinerated as chemical waste.
Task: reduction of incineration costs by volume reduction in reverse osmosis concentrate, re-use of permeate for the extraction.
Activities PS: project in several steps. Process screening (reversee osmosis and alternatives), small scale pilot over several months, comparison of membranes from different suppliers (independence from suppliers), simulation, process design and cost estimate for production plant. Pilot on-site with about 50m3 fresh feed solution. Final process design. Specialist support during start-up.
Result: Pay-Back below 1 year, plant was built in collaboration by an engineering company, second plant for the same customer was built in another country and together with another engineering company.
Purification of polymer solution in acetone
Problem: polymer solution contains a low Mw component that has to be removed and the molweight-distribution has to be shifted towards higher Mw.
Task: selection and test of suitable acetone stable membranes and modules. Production of purified polymer for use tests.
Result: An optimum membrane and alternative from different supplier found. High yield, good flux achieved, small diafiltration volume necessary.
Purification of a concentrated caustic solution
Problem: expensive caustic solution (LiOH) is currently send back to the manufacturer for purification for reuse. Colored impurities caused a price reduction.
Task: development of a membrane process to create a colorless permeate.
Activities PS: screening nanofiltration, membrane selection, small-scale pilot, cost estimation.
Result: technically and economically feasible process allows price discussions with the manufacturer.
Concentration of herbal extracts
Problem: herbal extracts are gaining more and more interest for pharmaceutical applications. Often they are extracted with alcohol/water. Tea extraction solution is quite dilute and extraction solvent has to be recovered. Products are temperature sensitive.
Task: development of a membrane process to concentrate the products at room temperature by a factor of 100. Reuse of the permeate for extraction in a closed loop.
Result: our client has patented the process for his herbal extract. The process is intersting also for many other herbal extracts.
Desalting of a special optical brightener
Problem: our client was looking for product quality emprovement by desalting of the product suspension. Success with filter press was limited. He had no success with his standard nanofiltration membrane that he uses for other applications (rapid flux decline).
Task: screening of membranes that allow desalination of this product.
Result: microfiltration can be used because this is a colloidal product suspension (and not a solution). Membranes with a special polymer operate without membrane fouling. Deslination at very low pressure without any problem is possible.
Reverse osmosis test unit
Problem: pharma products are often only available in small amounts dissolved in organic solvents. A special test unit was needed with small volume, solvent resistant and for high pressures
Task: development and construction of a lab unit for operation up to 100 bar operation without pressure superposition from pressurized gas bottles. Possibility of operation with supercritical CO2
Result: lab unit with flat-channel test cell (scale-up to spiral wound elements possible), dead volume 50ml, 100bar, for all solvents.
Concentration of a pharma product in pentane
Problem: pentane has to be recovered from a solution of a pharma product. Membrane alternative to distillation should be investigated, less energy consuming (avoids low termperature condensation).
Task: test of nanofiltration with solvent resistant membranes. Mesurement of permeate quality, permeate fluxes and possible concentration factor.
Result: we tested a polymeric nanofitration membrane that can be used for this or other apolar solvent. Very good flux and sufficient product retention. Process feasible, scale-up and cost estimation data available.
Purification of a fermentation product FX before and after chromatography
Problem: FX is produced in a fermentation process and has to be purified by chromatography. As pretreatment a low molecular weight organic substance has to be removed. After chromatography a salt (from the eluent) has to be removed and the solution has to be concentrated.
Task: selection of the proper membrane for both applications, purification and concentration of a small amount of product for further applications tests of our client.
Result: with the best membrane found in screening we produced 50ml of concentrated and purified product solution. After succesfull application tests our client ordered a small scale production unit.
Nanofiltratrion in non-aqueous systems
Problem: so far pressure driven membrane processes were often limited to aqueous applications.
Task: extending nanofiltration process to all sorts of solvents. Choice and test of suitable polymer and ceramic membranes
Result: for alcohols and some apolar solvents we have tested suitable polymeric membranes. For all solvents we can use ceramic membranes down to nanofiltration (slightly higher cut-off than polymeric). Adaption of test units for non aqueous applications.
Construction of tailor made pilot units
Problem: user of membrane processes need pilot units that fit their needs. For example if they need scalability to an existing production unit.
Task: construction of test and pilot units tailor made to the customers need. Working range (pressure, temperature, Ex-classification, pH, solvents), membrane area, membrane module types of different suppliers, instrumentration, scalability.
Result: several units built. Based on our experience we can construct a pilot unit also for very specific application and deliver it fast.
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