Process efficiencies are paramount to company success. In-line spectrometers can help pharma meet stringent industry regulations, while improving manufacturing costs and time expenditures going forward.
Bruker Optics entered the field of FT-IR spectroscopy in 1974. Since then, its product line has continuously expanded with performance-oriented instruments suitable for analytical and research applications. Bruker’s product lines span all major markets:
- Chemical and petrochemical
- Food and feed
- Pharmaceutical
- Cosmetics
What sets Bruker Optics apart from its competitors is its dedicated spectroscopy systems and unique expertise. It offers the widest range of products, from the smallest FT-IR spectrometer in the world to the highest resolution and best performance products available on the market.
‘Bruker Optics is recognised by the large pharmaceutical companies as the one-stop-shop for their process analytical technology (PAT) requirements,’ says Dr Jörg-Peter Conzen, vice president of Bruker Optics.
PAT is a mechanism used to design, analyse, and control pharmaceutical manufacturing by measuring critical process parameters and quality attributes. It is still in its infancy, but its potential is huge. All major pharmaceutical and biotech manufacturers recognise the need to ‘do it right the first time’ and implement established analytical tools.
‘With FT-NIR or Raman spectroscopy, we can monitor the different steps along the production chain, in particular, the relevant process steps,’ says Conzen. ‘The degree of false batches decrease drastically and downtime associated with issues such as cleaning validation can be minimised.’
Bruker Optics has a long and successful history of process applications. The first online installation was made in 1995, and in 1999 the first dedicated process spectrometer, the MATRIX-F, was brought to market.
Beyond the classical contact analysis with fibre optic probes, Bruker Optics’ process spectrometers cover innovative measurement technologies for non-contact analysis. This allows all aspects to be covered, from reaction monitoring to drying and blending applications.
NIR spectroscopy
Although there are a variety of analytical methods available, Bruker sees a strong focus on NIR spectroscopy, an easy-to-use and powerful tool that enables pharma to streamline manufacturing and research processes.
‘Measurements can be made non-invasively and non-destructively,’ says Conzen. ‘High quality spectra can be collected within a few seconds and, with the help of chemometric software, several parameters can be analysed simultaneously.’
In contrast to time-consuming methods such as HPLC or wet chemical analysis, NIR produces no waste or pollution and requires no chemical reagents. NIR spectroscopy can also generate information that allows for a detailed understanding of the ongoing processes and related mechanisms. In the long term, this will lead to further improvements of dedicated process steps, including risk minimisation.
To meet the demands of an industrial environment, Bruker Optics focuses on developing highly robust spectrometers. ‘Our special interferometer technology enabled us to make the spectrometers insensitive to vibrations but still highly accurate,’ says Conzen. ‘Our process spectrometers can work in an ATEX-rated environment and they conform to working in a GMP-validated environment. Special attention was paid to designing the instrument so that it can be easily serviced in the field by the user.’
According to Conzen, the biggest challenge regarding technology is ‘integration’ – to generate complete, integrated solutions for items such as blenders and dryers. Until now, only a limited number of complete solutions have been available. Instrument vendors sell their equipment and engineering companies do the same, but do so separately.
‘An important paradigm of the PAT initiative is not just about exchanging classical online or at-line methods by modern spectroscopic technologies – it goes further,’ says Conzen.