Select Page

How to Tackle Particle Contamination in Cell Therapy Manufacturing with Foamtec’s PolyCHECK® Process

by | Apr 3, 2024

Foamtec’s PolyCHECK® process is a valuable solution for cell therapy manufacturing facilities that cannot afford any rejected product due to particle contamination. In these facilities, particle prevention is crucial, and identifying the root cause sources of particles is essential. Let’s take a look at how the PolyCHECK® process was applied at a specific facility to identify single-use system components as a major source of fibers.

At this particular facility, the lot sizes were small, making it even more critical to prevent any particle contamination. The PolyCHECK® system was employed to monitor and analyze particle contamination in the aseptic environment of the cell therapy manufacturing facility.

During the sampling process, various areas within the cleanroom were assessed, including surfaces of equipment, robotic systems, tooling, stopper bowls, and preparation areas. The aim was to identify any potential sources of particle contamination.

As the PolyCHECK® process was implemented, it was discovered that the single-use system components used in the cell therapy manufacturing process were a significant source of fibers. These fibers were potentially introduced during the manufacturing and handling of these components.

By identifying the single-use system components as a major source of fibers, the facility was able to take appropriate corrective actions. This could include assessing the manufacturing process of these components, evaluating the handling procedures, or considering alternative materials that would minimize fiber generation.

Through the implementation of the PolyCHECK® process, the facility gained valuable insights into the root cause of the particle contamination issue. This enabled them to address the problem at its source, mitigating the risk of particle contamination and reducing the chances of rejected product due to particles.

Overall, the application of Foamtec’s PolyCHECK® process in cell therapy manufacturing facilities with small lot sizes is instrumental in identifying and resolving particle contamination issues. By identifying the root cause sources of particles, such as the single-use system components in this case, facilities can take proactive measures to prevent particle contamination and ensure the production of high-quality cell therapy products.

Learn more about the PolyCHECK System:

Foreign Material Identification Service