LEWA has created a novel inline dilution system for pharmaceutical supplier Bachem.
The solution will allow Bachem to expand its oligonucleotide production capacity at its main location in Bubendorf, Switzerland.
As the demand for oligonucleotide-based drugs is steadily increasing, API manufacturers must make their production processes better and more robustly scalable, but without risking compromised quality or cost effectiveness.
According to LEWA, this is its largest production building to date, as it can be used to meter buffer dilutions, with flow rates from 40 to 2,500L per hour.
Bachem requires this technology so it can ensure the continuous, automated supply of varying buffer solutions during the downstream purification process.
Five evodos hygeinic diaphragm metering pumps, which are all designed specifically for pharmaceutical applications, ensure that the entire API purification process is reproducible.
The importance of purification
When producing chemicals for biopharmaceuticals and APIs, purification in the downstream processing of substances through chromatography and filtration is of crucial importance.
For this purpose, the preparation of buffer solutions with high mixing ratio accuracy is critical, and the respective formulation of the individual solutions myst be highly variable.
As APIs experience increasing global demand, these process steps must be increasingly automated and integrated into complete production lines. This way, solutions can be mixed directly at the point of use according to the need for specific dilutions from available concentrates, which accelerates the entire manufacturing process while also reducing space requirements.
"One of the biggest challenges with inline dilution is maintaining consistently reproducible quality of the buffers required in each case," said Pietro Pettoruto, Managing Director of LEWA Switzerland AG.
One requirement for this is precise control of the flow rates and the resulting dilution ratios. The pumps used must be hygienic, robust and designed for continuous operation.
Supporting manufacturing flexibility
For LEWA to provide Bachem with a solution that is flexible enough for its needs, LEWA has incorporated five ecodos hygienic pumps into the plant — driven by mechanically actuated, multilayered sandwich safety diaphragms.
Therefore, the risk of contamination is avoided. Owing to the GMP environment, hygienic designs with certified construction materials were selected, all with wetted metallic parts which have been electropolished.
With this design, the pumps are easy to clean in place, without prior disassembly.
"Our system concept is a customised inline dilution system designed as a package unit (PU) for the downstream process in complex oligonucleotide production," added LEWA's Systems Manager of the Sales, Process Industry & Downstream department, Roland Schwab.