Flexible Production of Parenterals
The innovative benefits of Brinox process systems are production lines with a batch size ranging from 10% to 100% of nominal size.
The main processing units are typically implemented as stationary or mobile reactors or mixing vessels.
The auxiliary (e.g. energy) units are installed in the technical area as modular units with a minimum time of installation and optimum occupancy of space.
Another advantage of ours is the automation of cleaning, sterilization, and drying processes.
Case Study
Challenge:
- Customized solution to ensure the sanitary integrity of large series injection solutions production, the integration of an appropriate process solution to the existing technical space, and compatibility with the existing technical equipment.
Development and Implementation of the Solution:
- Design and implementation of a customized process system for the production of injection solution in desired amounts based on the flexible system of batch size ranging from 10% to 100% of nominal volume of equipment.
- Compatibility of the process solution with the existing technical equipment and space - all elements that were not necessary within a clean room we removed to the grade D technical areas or to the ‘grey’ areas.
- Fully automated production of injection solutions as well as automation of CIP, SIP and DIP processes without the need for operator intervention
- Executing the main mixing receptacle in accordance with the ATEX directive
- In-line filtration with in-line integrity testing of filters
- Optimization of production and assembly time, space while minimizing production loss.
- An innovative computer control system that exploits the advantages of centralized processing, archiving, and protection of data for the control and supervision of the operation of the entire production line with computer terminals, placed throughout various production areas and made accessible to users.
