Microbiologically controlled environments are used for many purposes within the pharmaceutical industry and, are especially important to control the risk of contamination of the aseptic processing environments. Possible contamination of pharmaceutical products could have a dangerous impact on patients that are the final target of pharmaceutical products: the main goal is to ensure the safety of the products and patients.
One of the principal ways to keep under control the contamination is to monitor the environment from the viable and non-viable points of view and ensure that the viable and non-viable particles are following the GMP requirements.
In this webinar, we’ll dive deep into the continuous monitoring approach, suggested by the guidelines to monitor the aseptic process int the New Annex 1, published in August 2022.
What we will cover:
- The importance of continuous monitoring systems
- Total particle continuous monitoring
- Viable continuous monitoring – active and passive air
- Risk assessment
Who should attend:
- Environmental Monitoring team members
- Quality Assurance
- Quality Control
- Production and project managers
- Compliance Specialists
- Engineers
