Rüschlikon, Zürich: – Mike Mandlehr, the Director of Sales & Marketing of Swiss-based fine chemicals and pharmaceutical process automation specialist SYSTAG, has taken part in a Question and Answer session, ‘Optimizing development resources for efficient product development’.
Mr. Mandlehr answers key questions about the company and its laboratory automation systems, to demonstrate how efficient process R&D have become crucial for modern contract and API manufacturers, with the need to push through new products/processes to market readiness ever faster, with full safety testing, overcoming barriers of scarce development resources and pressures of routine administration and regulatory requirement to keep detailed records.
Q: Who and what is SYSTAG?
MM: SYSTAG stands for System Technik AG. We’re a Swiss-based company, founded in 1965 to provide systems automation solutions for the chemicals and pharmaceuticals industries. We specialize in automation of Fine Chemicals and Pharmaceutical processes from milliliter Lab-Scale up to Kilo-Lab-Scale. Our strongest USPs are in the innovative nature of our technologies, our very high construction and engineering standards and in the scalability and flexibility of our systems, designed to provide easy scale-up at every key stage from development through piloting to production control technology.
Q: Why do R&D laboratories need greater automation?
MM: Well, nowadays, efficient process research and development are, more than ever, an absolute must for contract manufacturers and API manufacturers. New products and processes need to be pushed through to market readiness faster and faster. However, development departments suffer from a shortage of resources and the available employees are often overburdened with administrative tasks. So it is no wonder that in many cases there is less time available for serious process development. Time-consuming routine work such as dosing, tempering and similar control tasks can be left to an automated laboratory reactor while limited human resources can then be used for more important work.
Q: What are the benefits of Controlled Lab Reactors?
MM: SYSTAG’s Controlled Lab Reactor FlexyPAT and the Parallel Synthesis Workstation FlexyCUBE can help chemists greatly, providing systematic laboratory automation from the beginning of the development process. These controlled lab reactor systems deliver two main advantages.
First, their ability to provide comprehensive data capture and visualization make it possible to spot complex interrelationships even at a very early stage of development. Second, processes become much more robust and reproducible, eliminating variance in artifacts as well as human performance. In both these ways, more widespread use of lab automation, based on customized controlled lab reactors, enables enormous increases in efficiency of entire groups or departments.
There’s a third aspect to consider: regulation. Nowadays, strategic process optimization in Quality by Design (QbD) or statistic Design of Experiments (DoE) has become indispensable for fast and efficient process research and process optimization. As part of the regulatory trend, data traceability is becoming increasingly overt in very early stage development. Without closely controlled lab reactors, it isn’t possible to meet these new norms and standards.
Q: What are typical applications for your FlexyCUBE and FlexyPAT controlled lab reactors?
MM: Well, basically one obtains an advantage from using automated lab reactors wherever temperature controlled jacketed lab reactors or round bottom flask are used to perform synthetic reactions.
This ranges from chemical and pharmaceutical process research at milliliter-scale, through process development and thermal safety investigations for reaction calorimetry, all the way up to kilogram scale production.
Typical applications are for example, hydrogenation with elaborate inertisation cycles, or crystallization optimization with recurrent heating and cooling loops, with regard for Meta-Stable Zone determination. This involves, particularly when combined with an on-line turbidity meter, determining the turbidity point and solubility of a product at different concentrations as functions of temperature. If you want to do this using a conventional, manual, method, you’ll need a large number of tests with meticulous logging and subsequent evaluation. A ‘controlled laboratory’ on the other hand, performs all necessary steps fully automatically. These include not only the various heating and cooling cycles, but also the required dosage between each cycle to obtain solubility of a product at different concentrations. Here, time saving is an important factor in such applications, along with greater reproducibility.
To return to the hydrogenation example, we should also remember that, in addition to economy, safety is also significant factor. For hydrogenation, and indeed most gas reactions generally, the inertisation – reducing oxygen sensitivity – is often of paramount importance. With an automated lab reactor, all these phases can be carried out under so-called standard operation procedure (SOP) autonomously while maintaining quality at every stage. Furthermore, the exact recording of quantity of gas in hydrogenations is crucial.
In addition to the precise temperature control and pressure control the mixing (stir efficiency) at different stirring speeds, and thus the gas absorption, are essential, if for example, various catalysts are examined (catalyst screening). It is almost impossible to control and record all these parameters in a reproducible and continuous manner without laboratory automation. And here, our proven SYSTAG solutions show their strengths.
Q: How would you summarize the strengths of SYSTAG’s automated systems?
MM: SYSTAG develops modular and innovative tools for automating chemical synthesis reactions, from laboratory scale through to scale-up or mini-pilot. SYSTAG has more than 50 years of experience of applications and automation, based on our close cooperation with the chemical and pharmaceutical industries. We develop and offer customer-specific, systematic laboratory automation, all from a single source. Our knowhow becomes a strategic advantage for our customers, with the Swiss build quality of our products and exceptional customer service forming our brand value and our customers’ gain.