From passive to active air monitoring in aseptic filling: a risk-based approach to replacing settle plates

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In this webinar, Particle Measuring Systems shared a case study of a biopharmaceutical company developing and applying a structured global rationale for the implementation of continuous viable environmental monitoring with a single-use microbial impactor within aseptic manufacturing environments. 

Watch Takeda Pharmaceuticals International AG and Particle Measuring Systems for a practical discussion drawing on five years of operational experience implementing continuous viable environmental monitoring with BioCapt® Single-Use.

The webinar explored how regulatory compliance, quality improvement and operational efficiency can be brought together when developing an environmental monitoring strategy.

Key learning points

  • How to build a risk-based justification for replacing settle plates with continuous active monitoring.
  • How continuous viable monitoring can support your Contamination Control Strategy.
  • How to assess the impact on compliance, quality and operational efficiency.
  • What to consider when implementing the technology in new equipment and existing systems.
  • What lessons can be learned from Takeda’s experience with European regulatory authorities.

Real-world experience. Practical insights. Regulatory perspective.

Hear directly from Takeda about the considerations that supported the adoption of BioCapt® Single-Use as a global option for viable environmental monitoring.

The discussion covered: 

  • Reducing interventions during aseptic processing
  • Integrating viable air, total particle and surface monitoring
  • Smoke study expectations
  • Equipment design considerations
  • Retrofitting existing aseptic processing lines
  • Building and communicating a risk-based rationale
  • Engaging with European regulatory authorities

 

Watch on demand and discover how a risk-based approach could support the move from passive to active air monitoring.