Aseptic powder dosing from Romaco – integral line solutions

As globally renowned specialist for aseptic lines, Romaco supports its customers when planning and installing a new aseptic line: beginning from the feasibility study through to validation. In this way, the company creates a trustful basis for long-term cooperation. The line solutions can be individually adjusted to the process and production requirements of the customers and combined with other systems without any problems.

• Suitable for the operation in conventional clean rooms and with isolator
• Barrier technology (RABS) optionally available
• Equipped with in-line product quality control
• Statistical process monitoring possible
• Monitoring of viable and non-viable particles
• Special project management with a contact person

• Process analytical technology system in accordance with FDA and EMEA
• Improved operational safety thanks to automation
• Management of process variables
• Reduction of the global cycle time of the production thanks to online measurements and monitoring
• Less rejection and rework thanks to the greatest possible automation

• Acceptance test at the manufacturers' site (FAT) and the customers' site (SAT)
• Design qualification (DQ)
• Installation qualification (IQ)
• Operational qualification (OQ)
• Performance qualification (PQ)