This course introduces the core principles of aseptic processing in pharmaceutical and biopharmaceutical manufacturing. Through lectures and hands-on activities in a simulated CGMP environment, students gain foundational knowledge and practical skills essential to contamination control and sterile product manufacturing. Emphasis is placed on regulatory expectations, aseptic gowning, cleanroom behaviors, and developing an aseptic processing mindset to support compliant sterile manufacturing operations.
- Biopharmaceutical Technicians
- Biopharmaceutical Supervisors
- QA and QC Personnel
- Persons desiring entry into the Biotechnology field.
- Role and regulatory requirements of aseptic processing
- Cleanroom design, classification, and airflow control
- Microbiology fundamentals
- Environmental monitoring programs
- Cleaning, disinfection, and sterilization practices
- Equipment and component preparation
- Sterile filtration
- Formulation and compounding considerations
- Solution Preparation and Filtration
- Modern fill-finish operations
By the end of the course, students will be able to:
- Explain the role aseptic processing plays in pharmaceutical manufacturing.
- Apply CGMP knowledge to cleanroom activities.
- Describe cleanroom operations in relation to manufacturing parenteral products.
- Evaluate sterile gowning needs in various aseptic processing environments.
- Discuss microbiology and bacterial endotoxins in the context of parenteral drug manufacturing.
- Identify microorganisms of concern to biopharmaceutical processing.
- Evaluate environmental monitoring oversight of aseptic processes.
- Describe environmental programs and techniques.
- Compare and contrast cleaning, disinfectant, and sanitizer components and materials.
- Develop an aseptic processing mindset.
Delivered in-person in a classroom or lab setting.
This course introduces the core principles of aseptic processing in pharmaceutical and biopharmaceutical manufacturing. Through lectures and hands-on activities in a simulated CGMP environment, students gain foundational knowledge and practical skills essential to contamination control and sterile product manufacturing. Emphasis is placed on regulatory expectations, aseptic gowning, cleanroom behaviors, and developing an aseptic processing mindset to support compliant sterile manufacturing operations.
- Biopharmaceutical Technicians
- Biopharmaceutical Supervisors
- QA and QC Personnel
- Persons desiring entry into the Biotechnology field.
- Role and regulatory requirements of aseptic processing
- Cleanroom design, classification, and airflow control
- Microbiology fundamentals
- Environmental monitoring programs
- Cleaning, disinfection, and sterilization practices
- Equipment and component preparation
- Sterile filtration
- Formulation and compounding considerations
- Solution Preparation and Filtration
- Modern fill-finish operations
By the end of the course, students will be able to:
- Explain the role aseptic processing plays in pharmaceutical manufacturing.
- Apply CGMP knowledge to cleanroom activities.
- Describe cleanroom operations in relation to manufacturing parenteral products.
- Evaluate sterile gowning needs in various aseptic processing environments.
- Discuss microbiology and bacterial endotoxins in the context of parenteral drug manufacturing.
- Identify microorganisms of concern to biopharmaceutical processing.
- Evaluate environmental monitoring oversight of aseptic processes.
- Describe environmental programs and techniques.
- Compare and contrast cleaning, disinfectant, and sanitizer components and materials.
- Develop an aseptic processing mindset.
Delivered in-person in a classroom or lab setting.