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Multipurpose Pilot Plant for Plasma Processing

High flexibility for over 30 blood plasma-derived products.
Fully automated multiproduct system covering clinical and routine production of new products in addition to pilot production.

High-end engineering and integrated system solutions by ZETA. Supporting continuous 24/7 production.

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.

The challenge

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 goal was to minimize downtime, support continuous 24/7 production, and enable fully automated processes. Additionally, the project was under an extremely tight time schedule, adding pressure to meet all these requirements efficiently and effectively.

The solution

Crucial: engineering at an early stage

ZETA supported the project from early concept design through basic and detailed engineering, as well as commissioning and qualification of new recipes. By integrating these engineering and system activities, ZETA contributed to an efficient realization of the multipurpose plant. The project benefited from ZETA’s early integration into planning, enabling prioritized steps according to research progress.

Achieve maximum flexibility with mobile production units

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. High flexibility is enabled 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.

Provision of a fully automated system

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 of this modular pilot plant and ZETA’s further support for multiproduct plasma processing! 

Mastered challenges.

Cost transparency

Open-book accounting provided maximum control of expenses and cost truth at any time.

Functional completeness

Every piece of equipment is carefully coordinated to meet the specific size and quality requirements of each process.

Operation efficiency

ZETA assistance in ramp up and ongoing operation support.

Flexible Multiproduct Manufacturing Requires Intelligent System Integration

ZETA develops modular and fully automated production environments that support flexible process routing, scalable operations, and continuous manufacturing across complex biologics workflows.

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