In our second installment in the modular formulation system SVP video series, Stephan Huettner, head of engineering for process technology, introduces the technology live from our factory floor in Dresden, Germany.
Syntegon’s SVP process system is a highly modular and flexible solution for the production of small volume parenterales. It features a prefabricated integrated cleanroom design with all peripheral technology outside the cleanroom in a technical skid. The production area itself can also be separated, and run under different room classifications, as required by the application. The highest degree of flexibility is provided, in both the layout of the customer’s room concept and the configuration of the production units themselves.
Syntegon and the customer jointly define the shape, volume, and functionality of up to five fixed and mobile containers to deliver exactly the preparation system the customer needs for his products. Over 70 pre-tested functional modules are available to process batch sizes from 13 to 3,000 liters, offering unparalleled flexibility and convenience. From the optional mobile homogenizer to the integrated CIP module, everything is available. The prefabricated integrated cleanroom design includes the laminar flow and lighting units. And since the safety of operators and products comes first, we can meet complex requirements such as aseptic processing or the handling of toxic substances simply by including the appropriate functional modules.
Our automation architecture, which is structured according to ISA-88, is one of the foundations of our modularization concept. Mechanics, electronics, and software merge into intelligent mechatronic modules in our systems. The implementation of your individual recipe on the SVP process system can be realized in three different ways: program, production, and batch management sequences. We strive to define trends and drive digital production. The result: attractive solutions for production monitoring and control.
The SVP has your current and future small volume parenteral formulation needs covered.
