High-Precision Mobile Skids

Lipid nanoparticles (LNPs) are one of the most advanced technologies for efficient in vivo delivery of mRNA therapeutics and vaccines. ZETA supported a manufacturer in developing an mRNA-lipid nanoparticle mixing system and delivered six identical mobile skids for high-precision mixing to sites in Europe and the USA.

The customer requested an optimization of an existing mixing system for the preparation of the mRNA-lipid nanoparticle product. The system was required to provide high-precision mixing, dilution, and collection of input solution streams. The volumes of substances to be processed are in the milliliter range, requiring a complex piping system with small diameters. A major technical challenge was to align and synchronize the pumps to accurately achieve the required mixing ratio and maintain a defined flow through the pipework.

ZETA carried out process and detailed engineering of the high-precision system based on P&IDs and functional specifications provided by the customer. Piping routing was an important consideration in the 3D design: pipe lengths, bends and associated pressure losses were carefully balanced to achieve consistent and synchronized flows.

The basic components of the skids included peristaltic pumps, single-use filter capsules, a mixing tee provided by the customer, and cleaning-in-place equipment. Flowmeters control the pumps, which are positioned at specific angles to support effective draining of the integrated SU assemblies.

Following a master-copy approach, ZETA built six identical compact and mobile skids. Despite the challenges posed by the small pipe diameters (DN8), the system required high-precision welding. Welding quality was critical to prevent particle clogging and potential product loss.

In addition to functional testing, the FAT enabled further optimization of the integrated CIP system. The supply of a media storage system and its integration with the mixing skids was part of a follow-up project.