Good Aseptic Practices

Aims
To provide basic concepts of aseptic theory and practices for the biologics manufacture, covering typical aseptic fill and finish operations, including facility, utility equipment, personnel, various operational considerations and regulatory compliance requirements.

Outline Syllabus

• Challenges of maintaining sterility
• HVAC and associated room manufacture operations
• Environmental monitoring
• Personnel: training and gowning requirements
• Media Fill (process simulation study)

Course Description
This subject is designed to provide an understanding on the key GMP requirements for Biologics and Aseptic operations, and to enable participants to identify risk situations that may adversely impact sterility assurance.

The course consists of a lively mix of presentations, group exercises, and discussions. Copies of all presentation slides and handouts will be provided.

Who Should Attend
The course is designed to service a wide range of participants from various disciplines within the Biologics and Aseptic operations. Participants considering working in these sectors or those wishing to enhance their professional development and advancement in management are particularly encouraged to apply.

Learning Outcomes
On successful completion of this module, the student will be able to:

• State the special cGMP requirements for the manufacture of sterile products.
• Discuss the key principles of sterile manufacture to minimise risk.
• Understand the role of media fills in Sterility Assurance.
• Describe the difference between open and closed processing.

Register your interest