This course will provide an overview of the requirements for aseptic and bulk manufacturing operations, including facility design, contamination controls and acceptable personnel behaviors.
Cleanroom classifications and the techniques for proper cleaning and disinfection are presented; along with a high-level overview of microbiology in regards to cleanroom environmental monitoring and the associated impact to product and patient health and safety. This course will also review the guidance provided in USP <1116> to ensure compliance with regulatory expectations are met.
This is a course for people who need to understand the technical fundamentals of aseptic processing or who are responsible for aseptic operations in a lab, pilot or commercial setting. This aseptic training course is ideally suited to management teams, industrial microbiologists, scientists and engineers either with technical or managerial responsibilities in the biotechnology and pharmaceutical industries. FDB3085
Areas Covered in the Session:
Explain the difference between Aseptic and Bulk processing
Understand facility and personnel requirements necessary to maintain microbial control
Explain basic principles of microbiology and microorganism recovery in relation to cleanroom environmental monitoring (EM) and impact to product
Understand the gowning requirements associated with different cleanroom classifications
Explain basic principles of aseptic processing, including:
Cleanliness classifications
Process differences between aseptically produced and terminally sterilized product
Relation of manufacturing and handling procedures to sources of product contamination
The differences between cleaning, disinfection and sanitization
Proper cleaning / disinfectant technique
Elements of a robust environmental program and why EM is important
The role of isolator technology
The purpose of media fills, and elements critical to their success
Identify behaviors that are or are not appropriate when working in controlled areas, and why
Identify ways that they can impact/improve site-specific EM and aseptic behavior issues