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Addressing Non-Viable Particle Risks in GMP Facilities with Foamtec’s PolyCHECK Particle Identification System

by | Mar 17, 2023

Introduction

The growing adoption of single use bioproduction systems (SUS) in GMP facilities has revolutionized the biopharmaceutical industry. These systems offer many benefits, such as reduced cross-contamination, faster turnaround times, and cost savings. However, single-use systems have challenges, particularly concerning non-viable particle contamination. This blog will explore the risks associated with non-viable particles in GMP facilities that employ single use bioproduction systems and discuss how Foamtec’s PolyCHECK particle identification system can aid continuous improvement programs.

Non-Viable Particle Risks in GMP Facilities

Non-viable particles are solid, liquid, or gaseous substances that do not possess the ability to grow, reproduce, or metabolize. In GMP facilities, these particles can originate from various sources, including production equipment, raw materials, and human interaction. SUS are particularly vulnerable to non-viable particle contamination, as they often involve disposable components made of polymers, which can shed particles during use.

The risks associated with non-viable particles in GMP facilities include the following:

  1. Product contamination: Non-viable particles can compromise the quality, efficacy, and safety of the final product, leading to potential product recalls or regulatory actions.
  2. Equipment failure: Non-viable particles can cause abrasion, clogging, or wear and tear of sensitive equipment, leading to unexpected downtime and costly repairs.
  3. Compliance issues: Non-viable particle contamination may lead to non-compliance with GMP regulations, resulting in fines, delays, or the suspension of manufacturing operations.

Foamtec’s PolyCHECK Particle Identification System

Foamtec’s PolyCHECK particle identification system offers a comprehensive solution to mitigate the risks associated with non-viable particles in GMP facilities. The system features advanced technologies that enable precise identification and characterization of particles, aiding continuous improvement programs.

Key benefits of the PolyCHECK system include the following:

  1. Accurate identification: The system uses cutting-edge microscopy techniques and surface sampling to identify particles accurately based on size, shape, and chemical composition. This enables facilities to pinpoint the source of contamination and take corrective actions.
  2. Enhanced monitoring: The PolyCHECK system facilitates repeated monitoring of non-viable particles throughout manufacturing. This allows for the measurement of continuous improvement initiatives and the resolution of issues, preventing costly disruptions to production.
  3. Data-driven improvement: The system generates comprehensive reports on particle data, which can be used to drive continuous improvement initiatives. By analyzing trends and identifying areas for improvement, facilities can optimize their processes and reduce the risk of non-viable particle contamination.
  4. Regulatory compliance: The PolyCHECK system supports compliance with GMP regulations by providing accurate, reliable, and traceable data on non-viable particles. This helps ensure that manufacturing processes meet the stringent quality standards regulatory agencies require.


Conclusion

Non-viable particle contamination poses significant risks to GMP facilities employing SUS. Foamtec’s PolyCHECK particle identification system offers a powerful tool for addressing these risks, enabling facilities to accurately identify and monitor non-viable particles and drive continuous improvement efforts. By implementing the PolyCHECK system, GMP facilities can enhance product quality, maintain regulatory compliance, and reduce the risk of costly production disruptions.

PolyCHECK Particle Identification System Web Page

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

For Questions or Inquiries

Website: www.foamtecintlwcc.com

Email: contact@foamtecintlwcc.com