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.
The role of Media fills will also be explained; along with details on how to successfully perform a media fill.
At the completion of this course, attendees will be able to:
- 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 purpose of media fills, and elements critical to their success
- The role of isolator technology
- 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