A CO₂ extraction plant was designed and built ten years after the first product tests with the aim of replacing a conventional solvent process for degreasing and thus realize a much more sustainable, safer and faster production path. The system was supplied by Natex including installation and commissioning and meets all current GMP requirements.

Process conversion with added value

The solvent process previously used required complex solvent handling and a wide range of safety measures for people and buildings. The new CO₂ extraction not only reduces the ecological footprint and process time, but also increases safety for employees – for example, by eliminating flammable or toxic solvents and evaporating the CO₂ without leaving any residue. In addition, the new process is also faster: degreasing with CO₂ takes place in shorter cycle times thanks to optimized pressure and temperature control.

GMP-compliant design

The plant with its horizontal extractor is designed and built in accordance with the requirements of cGMP (current Good Manufacturing Practice). All components comply with hygienic principles. Full emptying, measuring devices free of dead space and well thought-out piping ensure short cleaning times and minimized contamination risks. The documentation and control were carried out taking into account customer expectations and the regulatory requirements in the pharmaceutical environment.

Modular design on skids & division into clean room and technical room

The entire system was manufactured on skids in a modular manner in order to minimize installation time on site and increase quality. A clear spatial separation of cleanroom and technical room modules ensures the required cleanroom class in the area in contact with the product, while all other parts are outsourced to the technical room. This keeps the cleanroom free of potential sources of interference and allows maintenance work outside the sensitive area.

Performance data & project implementation

• Horizontal extractor: First realization of an extractor with bayonet closure according to cleanroom requirements
• Scope of supply: Trials, engineering, production, assembly, commissioning by Natex on the basis of customer data and expectations
• Automation: Automatic process control using B&R’s APROL process control system with verified typicals
• Customer-specific process parameters: tested on Natex internal 80L pilot plant
• Skid modular design for rapid and controlled integration and construction
• Separation of clean and technical room for GMP-compliant plant architecture
• Cycle duration significantly reduced compared to the previous solvent process

This new CO₂ extraction plant represents an important milestone in terms of sustainability, safety and efficiency in the pharmaceutical environment. It proves Natex’s ability to implement CO2 extraction plants according to demanding GMP requirements.