Event
Course Description:
This course includes an overview of the sterilization process, key definitions, and types of sterilization. It provides guidelines for monitoring and testing bioburden, including recommended limits. Participants will be engaged in discussions, activities and/or case studies to reinforce key learning. The following USP General Chapters are covered: <1119>, <1119.1>, <1221>, <1222>, <1228>, and <1229>.
Upon completion of this course, you will understand:
- Explain key components of the cleanroom in sterile manufacturing and considerations in design of the cleanrooms.
- Describe various operational/monitoring controls to maintain the desired state in cleanrooms for sterile manufacturing across the life cycle.
- Demonstrate proficient knowledge of the roles of stakeholders in the design, operation and monitoring of cleanrooms in alignment with regulatory expectations via case study, Q&As, and knowledge checks.
- Explain the basics of sterile products and regulatory/scientific concepts, drivers of sterile products manufacturing and discuss key elements.
- Explain the use of different microbial enumeration methods for bioburden testing.
- Identify bioburden testing procedures and associated tests, such as the Growth Promotion Test.
Who should participate:
- Microbiologists
- Auditors
- Manufacturing companies
- RnD injectables companies
- DQA
- QA and QC controls
- Engineering
- Biopharma / Vaccine industry
- Aseptic control
- People working in sterile conditions