What’s covered in this Webinar
Environmental monitoring in aseptic manufacturing requires more than selecting a single monitoring technology: it requires a scientifically justified strategy tailored to the process, equipment and associated contamination risks.
In this webinar, a biopharmaceutical company and Particle Measuring Systems will share their experience in developing and implementing a structured global rationale for the implementation of continuous viable Environmental Monitoringwith BioCapt Single-Use within aseptic manufacturing environments.
The discussion will explore how regulatory compliance, quality improvement and operational efficiency can be combined when defining an environmental monitoring strategy. Drawing on five years of operational experience and data, a biopharmaceutical company will illustrate the considerations that supported the adoption of BioCapt Single-Use as a global option, including the importance of combining viable air, total particle and surface monitoring methods within a risk-based approach.
The webinar will explore the sterility assurance and compliance rationale for implementing BCSU solutions, both in new filling line designs and in the retrofit of existing aseptic processing lines. Practical implementation considerations will be discussed, including intervention reduction strategies, smoke study expectations, and key equipment design aspects. In addition, a biopharmaceutical company will share its experience in communicating this approach and rationale through interactions and training activities with European regulatory authorities.
Key Learning Objectives:
- Key elements to support a risk-based justification for the adoption of active continuous monitoring in place of settle plates.
- How continuous active microbial air monitoring can be integrated into an overall contamination control strategy.
- How to evaluate compliance, cost saving and quality improvement when implementing BioCapt Single-Use.
- Key considerations when implementing the technology in new equipment and existing systems, including intervention reduction, cost saving and quality improvement.
- Key regulatory considerations and lessons learned from a biopharmaceutical company’s experience with European authorities.
