High flexibility for over 30 blood plasma-derived products.

The interdisciplinary engineering team at ZETA, consisting of experts in process, mechanical, and automation engineering, developed and successfully implemented a versatile and fully automated multiproduct system for products derived from human blood plasma in an existing production facility. This highly flexible pilot plant is capable of production at various scales.

Our customer faced several significant challenges in their project. Maximum flexibility was crucial to ensure comprehensive coverage for all current, known, and potential new products. This required the development, quantification, and harmonization of processes for over 30 different products.

To achieve the necessary connectivity and functionality, 24 mobile vessels needed to be designed with the highest degree of flexibility. The project also had to contend with confined space conditions, making it essential to ensure easy access and maintenance despite the limited space.

The highest degree of efficiency means keeping downtime as low as possible, allowing production 24/7 and providing fully automated production processes. Additionally, the project was under an extremely tight time schedule, adding pressure to meet all these requirements efficiently and effectively.

ZETA met all project requirements by starting early with concept design and progressing through basic and detailed engineering to commissioning, and qualification of new recipes. By handling this wide range of services, ZETA set new benchmarks in multipurpose plant realization. The project’s success is largely due to ZETA’s early integration into planning, enabling prioritized steps according to research progress.

The highly flexible multiproduct system, designed to handle over 30 production processes, includes 24 mobile process units of different scales that can be connected to the auxiliary system (clean media, utility, electricity supply, CIP/SIP, waste removal) via 19 cleanroom wall-integrated docking stations. Maximum flexibility is guaranteed by the mechanical and electrical design of the system (unified heights of mobile units, pneumatic lifting, appropriate dimensioning of cables and air hoses), and by the automation intelligence included in the mobile units. The system detects which unit is docked, identifies its functionalities, and is always up to date on the current status of each mobile unit. Error-free docking and undocking allows to pursue a modular production concept.

Consistent functional specifications were developed based on the process descriptions and P&ID created by ZETA. With the customer’s choice of the Simatic PCS7 process control system and Simatic Batch, our automation engineers developed application software in compliance with GAMP5 and S88 standards. The installation of a batch management system with formula operation mode, along with the development of a sustainable reporting system for trend and production reports, adds significant value for both users and management.

Read more on the automation of the modular pilot plant and ZETA’s further support for multiproduct plasma processing!