Aseptic Transfer Best Practices: Ensuring Sterility in Biomanufacturing is an intensive workshop designed to equip biomanufacturing professionals with essential skills for maintaining sterility during material transfers. The course covers the fundamentals of aseptic techniques, cleanroom protocols, and step-by-step aseptic transfer procedures. Participants will also learn about handling and sterilizing equipment, troubleshooting contamination issues, and ensuring regulatory compliance. Through a mix of theoretical knowledge and hands-on practice, attendees will be better prepared to uphold sterility standards in biomanufacturing processes

Who should take this course?
This course is ideal for biomanufacturing technicians, operators, and process engineers responsible for aseptic transfers. Quality control and assurance personnel, production supervisors, managers, and regulatory affairs specialists will benefit from understanding aseptic transfer protocols to ensure compliance and process integrity. Additionally, training coordinators and R&D scientists involved in biomanufacturing will gain valuable insights into maintaining sterility.

Topics

Theoretical concepts and background:

• Overview of Cleanroom classification and contamination control 
• Aseptic processing and biopharma regulations
• Contamination control: EM, plates, hand hygiene, equipment sanitization and cleanroom sanitization
• Aseptic transfer practical
• Tube welding

Learning Objectives
Upon successful completion of this module, attendees will be able to:

• Understand importance of strategies for effective contamination control in cleanroom environments
• Gain knowledge of regulatory requirements and standards governing aseptic processing in the biopharmaceutical industry
• Conduct practical exercises in environmental monitoring (EM), using culture plates, and proper hand hygiene
• Master equipment and cleanroom sanitization techniques to maintain a sterile environment
• Perform hands-on practical sessions to execute aseptic transfers with minimal contamination risk
• Apply best practices and standard operating procedures for aseptic transfers in biomanufacturing
• Identify potential contamination sources and develop troubleshooting skills to address issues promptly
• Enhance problem-solving abilities in maintaining aseptic conditions during biomanufacturing processes

Delivery

• 0.5 days of theoretical instructor-led in-person classroom delivery at a CASTL Biomanufacturing Training Facility
• 1.5 days practical hands-on delivery at a CASTL Biomanufacturing Training Facility

Assessment

• A competency-based assessment will be undertaken at the end of the course. This will certify proficiency in the theory and practical skills.