This training course will help you understand the basic principles, processes and systems related to aseptic processing.

During this training course, you will learn about environmental monitoring systems, facility cleaning and disinfection, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation (media fill), and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, performing aseptic processes in ISO 5 conditions and performing visual inspection.

Learning Objectives:

1. Evaluate current aseptic processing procedures
2. Assess potential risks of product contamination using airflow visualization techniques
3. Determine the necessary components of an effective environmental monitoring program
4. Describe the importance of filter integrity testing
5. Examine cleanroom fill operations to ensure appropriate interventions and observations occur
6. Review basic microbiology concepts and techniques to multiple aspects of aseptic processing
7. Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems
8. Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing

Who Should Attend? 

• Professionals who are new to sterile drug manufacturing
• Individuals in the manufacturing, quality assurance, quality control and engineering departments
• Individuals in Management, Operators and technicians, Analysts, Specialists, and Engineers

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