This dual online course covers design, construction, and inspection of bioprocessing facilities in accordance with the ASME BPE standard, the B31.3 Process Piping code, and the Section VIII Pressure Vessel code. This combined arsenal of codes and standards incorporates regulatory requirements into their rules and recommendations to provide a comprehensive base of knowledge for design, construction, and inspection requirements as they relate to high-purity system design and construction. Also included in this course is a discussion that gets into the weeds with regard to the Canadian Registration Number (CRN) and how it relates to process pressure equipment and systems. By understanding ASME BPE and Canadian Registration Number regulations, your process facility can be built to maximize bio-burden control while minimizing operational concerns.
What will you learn in this course?
High purity design
1. Defining bioprocessing
2. Time and cost – getting a drug to market
3. A general understanding of codes and standards
4. A closer look into the ASME BPE standard
5. High purity design
6. System cleanability explained
7. A closer look at bioburden (Biofilm)
8. Liquid holds up cross-contamination
9. ASME BPE standard design elements
10. ASME BPE standard fabrication and installation
11. BPE clamp joint assembly
12. Examination. inspection. testing.
13. Leak testing
14. Turnover package
15. ASME BPE certification