Overview
This course is an introduction to the essential methods and practices for preventing, controlling, and managing contamination in an industrial production environment, in compliance with Good Manufacturing Practice (GMP). While emphasizing the importance of traceability and documentation to maintain rigorous quality standards, it addresses key issues such as hygiene, production area management, aseptic techniques and cleanroom behaviour as well as methods for cleaning and disinfecting cleanrooms and equipment, the protective equipment required according to the grade of the area, and environmental monitoring. This course includes a combination of theoretical and practical training.

Who should take this course?
Individuals aspiring to enter the biopharmaceutical or pharmaceutical industry in entry-level positions, as well as those already in the industry who wish to deepen their knowledge of contamination control in industrial production.

Key Topics

• Contamination risk assessment (microbial, chemical and physical) in the manufacturing process
• Contamination control strategies, including management of sensitive areas, rigorous hygiene, aseptic techniques, validated cleaning and disinfection techniques.
• Grade-specific dressing to reduce the risk of cross-contamination (i.e., wearing appropriate protective clothing according to the requirements of different grades of production areas (e.g., high and low contamination zones) 
• Control production environments (i.e., applying environmental control practices—air quality, temperature, humidity, viable and non-viable particle counts—to maintain an optimal manufacturing environment

Learning Objectives

• Understand the fundamental principles of contamination in industrial environments
• Become familiar with contamination prevention and control strategies
• Apply protective clothing rules according to the grade of production areas
• Understand how to apply rigorous environmental control

Delivery

• In English
• 1 day practical at the CASTL Biomanufacturing Training Facility in Charlottetown