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Safeguarding Single-Use Bioproduction Systems: The Role of Foamtec’s PolyCHECK Particle Identification System

by | Mar 24, 2023

Introduction

The advent of single-use bioproduction systems has revolutionized the biopharmaceutical industry, bringing increased flexibility, lower costs, and reduced risk of cross-contamination. However, these benefits come with challenges, including non-viable particles in the manufacturing process. These particles can pose significant risks to product quality and patient safety if not effectively monitored and controlled. This blog will explore the hazards of non-viable particles in single-use bioproduction systems and how Foamtec’s PolyCHECK particle identification system can help enhance continuous improvement programs and ensure a safe, high-quality end product.

The Risks of Non-Viable Particles in Single-Use Bioproduction Systems

Non-viable particles are particulate matter that does not contain living microorganisms. They can originate from various sources in single-use bioproduction systems, including the manufacturing process, handling and assembly, and the materials used in the systems. The presence of these particles can lead to several risks, such as:

  1. Product Contamination: Non-viable particles can interact with biopharmaceutical products, potentially causing changes in the product’s physical, chemical, and biological properties. This can lead to alterations in product efficacy, stability, and safety, ultimately compromising the quality of the final product.
  2. Process Interference: Non-viable particles can also interfere with critical steps in the bioproduction process, such as filtration, chromatography, and cell culture. This can reduce process efficiency, lower product yields, and increase waste generation.
  3. Regulatory Compliance: Regulatory authorities like the FDA and EMA have stringent guidelines for particle monitoring and control in biopharmaceutical manufacturing. Failure to adequately manage non-viable particles can lead to regulatory non-compliance, resulting in costly delays, product recalls, and reputational damage.

Foamtec’s PolyCHECK Particle Identification System: A Solution for Continuous Improvement

Foamtec’s PolyCHECK particle identification system offers a robust solution to address the risks of non-viable particles in single-use bioproduction systems. This innovative technology provides several key advantages:

  1. Rapid and Accurate Particle Identification: The PolyCHECK system utilizes advanced microscopy and spectroscopy techniques to accurately identify and characterize non-viable particles. This enables quick identification of the source of contamination and facilitates root-cause corrective action, minimizing the impact on product quality and manufacturing timelines.
  2. Comprehensive Analysis: The system’s easy-to-use surface sampling allows all component and production steps to be mapped for contamination. This identifies high-risk areas and guides continuous improvement initiatives.
  3. Enhanced Process Understanding: The PolyCHECK system’s ability to identify and characterize particles in-depth help manufacturers gain a better understanding of their processes, allowing for the optimization of single-use systems and the implementation of effective preventative measures.
  4. Regulatory Compliance: By providing accurate particle identification and monitoring, Foamtec’s PolyCHECK system helps manufacturers maintain compliance with regulatory guidelines, ensuring the safety and quality of their biopharmaceutical products.

Conclusion

The presence of non-viable particles in single-use bioproduction systems can pose significant risks to product quality and patient safety. Foamtec’s PolyCHECK particle identification system offers a powerful tool for addressing these challenges and facilitating continuous improvement initiatives. By leveraging this technology, biopharmaceutical manufacturers can enhance process understanding, optimize their single-use systems, and ensure the safety and quality of their products while maintaining regulatory compliance.

PolyCHECK FM Idenfication System:

https://www.foamtecintlwcc.com/products/foreign-material-identification-service

For questions or inquiries:

Website: www.foamtecintlwcc.com

Email: contact@foamtecintlwcc.com