There is a newer edition of this document available. This Standard deals with the requirements applicable to the design used in the bioprocessing, pharmaceutical, and personal care product industries, covering directly or indirectly the subjects of materials, design, fabrication, pressure systems (vessels and piping), examination, inspection, testing, and certification. Engineering judgments must be consistent with the fundamental principles of this Standard. Such judgments shall not be used to override mandatory regulations or specific prohibitions of this Standard.