Many of the drug products manufactured for use are injected into our bodies. By avoiding our first line of defense against infection, any possible source of infection can wreak havoc on our immune systems. In order in insure our safety, these drugs must be produced aseptically, meaning with little to no source of infection.
Aseptic processing is the process by which these drugs are produced aseptically. Aseptic techniques are the principles by which aseptic processing is done.
This web seminar provides a comprehensive overview of aseptic processing and aseptic techniques.
Learning Objectives:
- Provide background information on what is aseptic processing.
- Understand the different methods by which drug products are rendered sterile.
- Understand the controls put into place to insure product sterility
- Describe the interrelationship between the components used for aseptic processing.
- Describe a process flow of aseptic processing.
Areas Covered in the Session :
- Definition of aseptic processing
- Principles of aseptic processing
- FDA guidance document on aseptic processing, September 2004
- EU Annex 1, sterile manufacturing
- Regulatory expectations
- Definition of aseptic technique
- Principles of aseptic technique
Who Should Attend:
- QA/QC Departments
- Contract manufacturing companies (CMOs)
- Manufacturing Departments
- Operations Departments
- Personnel involved with aseptic processing operations
