Stefan Steigerwald, CEO Sympatec Inc. (US)
Considering the nature of the business, the pharmaceutical industry operates in one of the most dynamic environments and is full of challenges. The most common among them is adhering to the regulatory compliance. “There is no point in making a good drug if you can’t meet the regulations to get it to the patients,” points out Stefan Steigerwald, CEO of Sympatec Inc. The company helps pharmaceutical clients in meeting the regulatory guidelines concerning the particle size of drugs and excipients, with focus on inter-instrument comparability. Sympatec pioneered dry powder analysis with Laser Diffraction in the 1980s and is still the technology leader for laser diffraction be it wet or dry. With its diverse and modular range of instruments and accessories, as well as unremitting innovations in the technological fields of ultrasonic extinction, laser diffraction, photon cross-correlation spectroscopy (PCCS), and dynamic image analysis, the company helps its clients in the better analysis of particle shape and size of their medicine particles while ensuring they are in line with regulatory requirements and quality standards of the pharmaceutical industry.
Sympatec makes a prominent contribution to the development, production and quality control of the most challenging particulate systems. “At Sympatec, we not only manufacture particle size and shape analyzers, but we also assist our clients with selecting the right instruments for their application, install, qualify and service them. We work with our clients very closely, and make sure that all we are contributing to their product and their R&D is in line with the regulatory requirements,” states Steigerwald.
With Sympatec’s particle measurement instruments, clients get the most accurate, reproducible and comparable results at shortest measuring times in laboratory as well as in process settings. “For quality control, our clients look for valid particle sizing results. This starts in product and methods development and has to follow on every step of the scale-up process from lab bench to production scale. By employing the same measuring principles and technologies, comparability between lab and in-process control is achieved.
At Sympatec, we not only manufacture particle size and shape analyzers, but we also assist our clients with selecting the right instruments for their application, install, qualify and service them
The ability to control your process in real time really contributes to achieving Quality by Design,” mentions Dr. Sebastian Röthele, Head of Marketing at Sympatec.
With their flagship dry powder disperser RODOS, Sympatec has revolutionized the way particles are being measured in the pharmaceutical laboratory. Rounding out the innovative instrument offerings is the particle measurement application software PAQXOS. This software is the joint base for all Sympatec instruments and is flexible and adaptable to the requirements of the specific application addressing all functions and offering intuitive solutions for reliable measurement operations. Besides, the application software offers graphical presentations, tables, and paper reports that clients can choose from a range of pre-defined formats, or they can design their own custom reports. It also includes all features required to help clients achieve 21 CFR part 11 compliance. “Our software is highly scalable, and all reports can be customized with a variety of graphs and tables. What is really outstanding is that all our instruments are controlled by the same piece of software that covers all four technologies that are being used. Our clients can easily continue measuring with different kind of technologies, different kinds of instruments, without the need to learn a new software,” explains Steigerwald.
Explaining how Sympatec has achieved a level of unwavering trust among its clients and is continually delivering the best of products, Steigerwald says that they keep a constant check on their quality management system so that they do not just meet official directives and international standards but also meet demanding individual company standards. Besides, the company also focuses on after sales service and user training. “We provide life-long service to our customers. We go to our client’s facility, we train them, help them in familiarizing with the instruments. A few months later we again visit our clients to refine their information and also re-introduce them to the added features if there is any, so it is an on-going process,” he adds.
For the future, Sympatec plans to listen even more to their clients and their needs, which will drive their innovation. “We want to innovate in areas where our pharmaceutical clients need innovations. We are following this process for the last 35 years, and this is how we have achieved technological leadership in this market segment,” concludes Röthele.