Our process systems are engineered for critical pharmaceutical applications, including solution and buffer preparation, bioreaction, and fermentation.

Our approach starts with a detailed analysis of process requirements, product characteristics, and the customer’s validation needs. This enables us to identify the most suitable technologies for mixing, temperature control, filtration, cleaning, sterilization, and process supervision.

For customers, this means:

• Improved process reliability, repeatability and GMP compliance;
• Effective contamination control and sterilization performance;
• Better control of critical process parameters;
• Easier validation and qualification processes;
• Top quality and full traceability of critical components;

All systems are designed and developed in compliance with GMP requirements and supported by FAT, SAT, commissioning, and validation services, complemented by remote support, dedicated spare parts management, and tailored maintenance plans throughout the entire lifecycle of the plant.

Our systems can be supplied as:

• Stand-alone units;
• Fully integrated with the automatic machines (plug-and-play).

Our approach is based on complete customization, tailored to the specific characteristics of the customer’s product and process, ensuring maximum design flexibility.

This allows customers to optimize:

• cleaning and sterilization effectiveness, even in the presence of complex geometries;
• system and process reliability, reducing the risk of cross-contamination;
• cycle speed, minimizing equipment downtime;
• water, energy, and chemical consumption, delivering benefits in terms of sustainability and operating costs.

All systems are designed in full compliance with FDA regulations and EU GMP Annex 1 requirements, ensuring critical process parameter traceability, cycle validation, and integration with automation and supervisory systems for real-time monitoring and control.