By William M. (Bill) Huitt
The merely accomplished and authoritative reference consultant to the ASME Bioprocessing Piping and kit (BPE) standard
This is a better half consultant to the ASME Bioprocessing Piping and gear (BPE) ordinary and explains what lies at the back of a number of the standards and proposals inside that general. Following an introductory narrative to the Standard's early background, comparable codes and criteria are defined; the layout and engineering points hide building fabrics, either steel and nonmetallic; then parts, fabrication, meeting and deploy of piping platforms are explored. exam, Inspection and checking out then precede the ASME BPE certification strategy, concluding with a dialogue on method design.
The writer attracts on decades' event and insights from first-hand involvement within the box of business piping layout, engineering, development, and administration, along with the bioprocessing undefined. The reader will examine why dimensions and tolerances, method instrumentation, and fabric choice play such an essential component within the manufacture of elements and instrumentation.
This effortless to appreciate and navigate consultant will support engineers (design, piping, chemical, etc.) who have to comprehend the root for a lot of the Standard’s content material, as do the contractors and inspectors who've to fulfill and validate compliance with the BPE Standard.
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Extra resources for Bioprocessing Piping and Equipment Design: A Companion Guide for the ASME BPE Standard
Com/. © 2016 Arc Machines, Inc. 4 Tube weld tolerances. D. concavity (suckback), (e) lack of penetration, and (f) convexity. org/products/codes‐standards/bpe‐2014‐bioprocessing‐equipment. 1 Acceptable weld profile for a beadless weld. org/products/codes‐standards/bpe‐2014‐bioprocessing‐equipment. 2 Unacceptable cracks or crevices in weld profile of a beadless weld. org/products/codes‐standards/bpe‐2014‐bioprocessing‐equipment. 3 Unacceptable pits or pores in weld profile of a beadless weld. org/products/codes‐standards/bpe‐2014‐bioprocessing‐equipment.
Also woven into the pages of this book are lessons learned by over five decades of work in the piping design and engineering field by the author. These are lessons not found in codes or standards, but are instead methods and procedures developed by the author to enhance the execution of a project. ASME codes are typically not written to serve as design guides and are stated as such in their introduction. The BPE Standard though is very different in this respect as design of high‐purity systems is at the very heart of the BPE Standard.
Microbial Limits IV. Water for Injection Systems V. Still VI. Heat Exchangers VII. Holding Tank VIII. Pumps IX. Piping X. Reverse Osmosis XI. Purified Water Systems XII. Process Water XIII. Inspection Strategy Appendix D: Guide to Inspections of Lyophilization of Parenterals Guide to Inspections of Lyophilization of Parenterals Introduction Product Type/Formulation Filling Lyophilization Cycle and Controls Cycle Validation Lyophilizer Sterilization/Design Finished Product Testing For Finished Product Inspection ‐ Meltback Appendix E: Guide to Inspections and Validation of Cleaning Processes Guide to Inspections and Validation of Cleaning Processes I.
Bioprocessing Piping and Equipment Design: A Companion Guide for the ASME BPE Standard by William M. (Bill) Huitt