Development of a flow cell for process control in the production of biopharmaceuticals
The use of spectroscopic analysis methods for monitoring critical process steps is becoming increasingly important in a growing number of applications in the manufacturing industry. In highly regulated areas of application, such as pharmaceuticals, the required standards for optical measurement components in terms of quality, consideration of GMP guidelines and reproducibility can therefore often not be met with conventional manufacturing processes. This is also true for the production of biopharmaceutical active ingredients.
As the central measuring component for a single-use inline sensor interface for UV spectroscopic concentration measurement of biomolecules, Sartorius, a leading international partner in the biopharmaceutical industry and research sector, required a complex optical single-use flow cell made of quartz glass. Previously available single-use UV sensor technology did not meet Sartorius' expected requirements, especially in terms of dead volume, price-performance ratio and environmental footprint. In contrast, the Quartz Cold Casting (QCC) manufacturing process developed by Hellma is suitable for such demanding applications due to its high flexibility and easy adaptability.
In the QCC technique, a silicon-containing casting compound is poured into molds at room temperature, cured and converted in a thermal process into pure quartz glass that meets optical requirements. Since the molds can be designed flexibly, the measurement cell can be constructed in such a way that it is particularly simple and fits precisely. Based on the feasibility of the Quartz Cold Casting process (QCC) and taking into account the requirements arising from the process environment, relevant regulations and the required quality, Sartorius and Hellma are jointly developing a cost-effective single-use flow cell for the BioPAT® Spectro UV Single-Use Pipe sensor interface from Sartorius, which is being developed at the same time.
With the successful implementation of this customer project, the new cold casting manufacturing process was successfully used for the production of cost-effective single-use optics for UV spectroscopic analysis in biotechnology. The flexibility and efficiency in the realization of customer requirements also make the QCC technology interesting for a variety of other applications. This applies in particular to chemistry, pharmaceuticals, biotechnology, life sciences and the food industry.
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