From passive to active air monitoring in aseptic filling: a risk-based approach to replacing settle plates
In this webinar, Particle Measuring Systems will share 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.
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 Monitoring with 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, aĀ 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, aĀ 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 companyās experience with European authorities.
Who should attend:
- Quality Control
- Quality Assurance
- Sterility Assurance
- Environmental Monitoring department
- Validation
- Production
- Manufacturing
- Process Engineering
- Engineering
- Auditors
Speakers
Giulia Artalli
Global Product Line Manager, Microbiology & Sterility
Giulia Artalli is Global Product Line Manager at Particle Measuring Systems, specializing in microbial environmental monitoring for pharmaceutical cleanrooms and GMP-regulated manufacturing. With over 20 years of experience in pharmaceutical microbiology, she advises global life sciences companies on contamination control strategies and regulatory compliance. Giuliaās background spans research and leadership roles at Becton Dickinson and Diversey, where she focused on microbiological risk mitigation in sterile production. She routinely educates cleanroom professionals on environmental monitoring best practices, Annex 1 updates, and microbial detection methods. Giulia brings a strong foundation in applying industry standards to viable particle monitoring programs. She presents internationally and contributes to Particle Measuring Systemsā global leadership in contamination monitoring for the life sciences industries.
Anna Campanella, PhD
Global Aseptic Processing & Sterility Assurance Lead, Takeda Pharmaceuticals International AG - Zurich
Anna Campanella holds a Ph.D. in Molecular Medicine and boasts 19 years of experience in the pharmaceutical industry. She began her journey in microbiological and biochemical laboratories, specializing in sterile injectable products and aseptic production processes. Over the years, she took on pivotal roles, including QA&QC Manager and Global Head of Sterility Assurance, increasing her experience using QRM and QbD methodologies. Anna’s expertise spans microbiological and particle impact assessments in pharmaceutical processes, and she is renowned for crafting advanced Contamination Control Strategies.