Single-use bioproduction systems have revolutionized the biopharmaceutical industry by eliminating the need for cleaning and sterilization between batches, thereby reducing the risk of cross-contamination and increasing productivity. However, as with any manufacturing process, ensuring cleanliness is critical to product quality and safety.
In this blog, we will discuss how Foamtec’s PolyCHECK swabs and the PolyCHECK particle identification system can aid manufacturers and users of single use bioproduction systems in validating cleanliness by enabling the sampling of the inner dimensions of TPE and silicone tubing assemblies.
The challenge with single use bioproduction systems is that, unlike traditional stainless-steel equipment, the inner dimensions of tubing assemblies cannot be visually inspected for cleanliness. As a result, it can be challenging to validate cleanliness and identify potential sources of contamination. Foamtec’s PolyCHECK swabs are uniquely designed to address this challenge by providing access to the inner dimensions of tubing assemblies, allowing for the sampling of hard-to-reach areas.
The PolyCHECK swabs are made from a highly charged fabric, allowing the collection of particles in the dry state. The particles adhere so they can be transferred to a lab and onto SEM stubs and FTIR windows for identification analysis.
In addition to the PolyCHECK swabs, Foamtec’s PolyCHECK particle identification system provides an advanced tool for validating cleanliness in single use bioproduction systems. The PolyCHECK process identifies and quantifies particles from various sources, including tubing assemblies, manifolds, and other critical process components. By identifying potential sources of contamination, the PolyCHECK particle identification system enables manufacturers and users of single use bioproduction systems to take targeted corrective actions to ensure product quality and safety.
In conclusion, Foamtec’s PolyCHECK swabs and the PolyCHECK particle identification system are valuable for validating cleanliness in single use bioproduction systems. By enabling the sampling of the inner dimensions of TPE and silicone tubing assemblies and identifying potential sources of contamination, these tools can help ensure product quality and safety while maintaining the efficiency and productivity benefits of single use bioproduction systems.
PolyCHECK Swab Video
PolyCHECK FM Identification Video
For questions or inquiries: