scope:

This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the subjects of materials, design, fabrication, pressure systems (vessels and piping), examinations, inspections, testing, and certifications. Items or requirements that are not specifically addressed in this Standard cannot be considered prohibited. Engineering judgments must be consistent with the fundamental principles of this Standard. Such judgments shall not be used to overrride mandatory regulations or specific prohibitions of this Standard.