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Mastering Contamination Control Strategy: How Foamtec’s PolyCHECK System Strengthens Your CCS

by | Jul 9, 2024

The revised Annex 1 of the EU GMP Guide renews the emphasis on a holistic Contamination Control Strategy (CCS) for sterile manufacturing facilities. This strategy demands a multi-pronged approach to identifying and mitigating potential sources of contamination throughout the production process. While creating and implementing a robust CCS can be challenging, Foamtec’s PolyCHECK® sample collection and analysis system empowers you to take significant strides toward achieving this goal.

Particles collected from an aseptic surface with the PolyCHECK Wipe being illuminated with a UV Light.

 

The Challenge: Implementing a Comprehensive CCS

The new Annex 1 emphasizes the importance of a site-wide CCS but doesn’t dictate a specific format or structure. This flexibility allows for customization but also presents a challenge for manufacturers. Key considerations include:

  • Identifying all relevant elements and critical control points within your facility.
  • Implementing suitable prevention, monitoring, and control measures for these elements.
  • Regularly assessing the collective effectiveness of all CCS measures.
  • Continuously improving the CCS through ongoing reviews.

 

 

SEM Photo and FTIR plot of polyester and cellulose particles collected on the PolyCHECK wiper

 

FTIR plot of the polyester wiper used in A and B (Left). FTIR plot of polycellulose nonwoven wiper used in Suites C, D and Material transfer airlocks (Right).

 

 

How PolyCHECK Bolsters Your CCS and CAPA Process

Foamtec’s PolyCHECK system significantly enhances your CCS and Corrective And Preventive Action (CAPA) process in several ways:

  • Superior Collection Efficiency:Unlike traditional particle monitoring methods that rely on passive air collection, PolyCHECK employs a direct-to-surface sampling approach. This enables the system to gather a more comprehensive and representative sample of contamination on equipment surfaces. This is particularly advantageous for capturing fibrous particles that may not readily become airborne.
  • Precise FTIR Analysis:The PolyCHECK system integrates seamlessly with Fourier-Transform Infrared (FTIR) spectroscopy instruments. FTIR analysis provides a highly detailed chemical fingerprint of the collected particles. This allows for the precise identification of organic materials such as fibers, a common contaminant in GMP environments.
  • Effective Root Cause Identification:Combining thorough collection with advanced analysis, PolyCHECK equips you with the data needed to pinpoint the source of contamination events. Traditional methods might reveal the presence of a fiber, but PolyCHECK with FTIR analysis can differentiate between, for example, a shed cotton fiber from a glove and a detached filter fiber from a process component. This granular data empowers you to identify the root cause of contamination events with much greater precision.
  • Targeted Corrective Actions:With a clear understanding of the root cause, you can develop more targeted and effective corrective actions. For instance, if PolyCHECK identifies polyester fibers, you might focus on corrective actions on sterile wipers. This reduces the risk of recurring contamination events and ensures a more efficient use of resources.
  • Preventive Action Potential:By identifying trends or patterns in particle data, PolyCHECK can help you anticipate potential contamination issues before they occur. For example, if PolyCHECK detects a rise in a specific type of fiber, you can investigate potential shedding sources before they impact product sterility. This proactive approach allows you to implement preventive actions, minimizing the risk of future problems.
  • Continuous Improvement:PolyCHECK data provides valuable insights for ongoing CCS improvement. By tracking particle trends over time, you can assess the effectiveness of existing control measures and make data-driven decisions for further optimization.

PolyCHECK: A Powerful Ally in GMP Compliance

Foamtec’s PolyCHECK system goes beyond traditional particle monitoring, offering a deeper understanding of contamination sources within your facility. This enhanced knowledge empowers you to effectively implement your CCS, strengthen your CAPA process, and ultimately achieve superior sterility assurance. By proactively addressing contamination risks, PolyCHECK can help you ensure ongoing compliance with Annex 1 requirements and contribute to the production of safe and high-quality sterile products.

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