The production of modern medicinal injectable products requires good aseptic techniques, a fundamental of manufacturing practices, and/or terminal sterilization, to control the encroachment of the manufacturing environment into a high-risk zone. There are ISO standards and GMP guidelines that promote the application of good aseptic practices, and these are demonstrated using a suitable monitoring program.
So, what suitable environmental monitoring is required to meet the requirements of ISO and the regulatory bodies? This webinar will review how the standards and regulations promote a cohesive environmental program, which is applicable to the risks pertaining to certain manufacturing environments, we will look at manual compounding in laminar flow hoods, through to filling lines, both open and closed systems.
What you’ll learn:
- Review of the regulatory standards, including the new ISO 14644 Technical Report 21
- Risks in sterile manufacturing
- Instrumentation choices associated with the regulatory needs
- Manual compounding in laminar flow hoods
Who should attend:
- QA & QC
- Production and maufacturing teams
- Environmental monitoring experts
- Biologists
- R&D team
- Biopharmaceutical engineers
- Regulatory experts
- Compliance Specialists
- Facility Managers
