Essential Manufacturing Skills - Principles and Usage of Isolators

This two-day, laboratory-based, training course is hands-on and designed to ensure individuals working with Isolators are well-prepared to maintain aseptic conditions, comply with regulatory requirements, and contribute to the safe and efficient operation of isolator-based processes in biopharmaceutical manufacturing.​

Learning objectives:

• To understand and follow Health and Safety protocols for working with isolators, including personal protective equipment (PPE), decontamination, and emergency procedures.​
• To familiarise learners with the design, positioning, and components of Isolators, including air handling systems, glove ports, pass-through chambers, and the isolator's physical layout.​
• To apply aseptic techniques for working within the isolator to prevent contamination of sensitive products or materials.​
• To understand decontamination methods, including hydrogen peroxide vapor (HPV) decontamination, how to effectively decontaminate and clean the isolator between processes.​
• To explain the use of control systems for adjusting environmental conditions within the isolator, such as temperature, humidity, and pressure differentials and learn correct procedures for transferring materials and components in and out of the isolator while maintaining sterility. ​
• To apply GxP regulatory and quality assurance principles, investigate industry best practices, emerging technologies, trends, and standards for maintaining sterile environments and evaluate the importance of continuous improvement in aseptic techniques.

Who should attend:

Delegates new to working within a biopharmaceutical or advanced therapies laboratory setting or those currently working in a highly regulated environment who wish to develop a theoretical and practical understanding of Isolator operation and maintenance. Amongst others, individuals who could benefit from this course are Manufacturing Operators and Technicians, Quality Assurance and Quality Control Specialists, Production Managers and Supervisors, Biotechnologists and Scientists, as well as personnel in regulatory.​