Overview
This workshopis  designed to equip biomanufacturing professionals with essential skills for maintaining sterility during material transfers. It 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 lectures and hands-on practice, participants will be 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. Training coordinators and R&D scientists involved in biomanufacturing will also gain valuable insights into maintaining sterility. 

Key Topics
Theoretical concepts and background: 

• Overview of cleanroom classification and contamination control  
• Aseptic processing and biopharmaceutical regulations 
•  Hands-on practical sessions: 
• Contamination control: EM, plates, hand hygiene, equipment sanitization and cleanroom sanitization 
• Aseptic transfer
• Tube welding 

Learning Objectives

• Understand the 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

• In English
• 2 days practical at the CASTL Biomanufacturing Training Facility in Montreal