2007 Edition ASME BPE Standard - KLEAN1（2007版ASME BPE标准KLEAN1）.pdf

2007 Edition ASME BPE Standard Presentation Review Lloyd J. Peterman, Director, International United Industries Inc. Presented For CHINA-PHARM 2008 Beijing, China PRC ASME Bioprocessing Equipment Standard Or ASME BPE 2007 Edition Introduction The standard was started in 1988 with a small task group at the ASME Annual meeting ASME BPE Standard is a worldwide standard for the Biopharmaceutical, Personal Care, API industries and other hygienic industries Why Develop a Standard? The lack of applicable industry standards for biopharmaceutical in 1988 Industry demands for higher quality associated with hygienic process systems and sterilization needs First ASME BPE Standard was issued in 1997, the fastest standard published in the history of ASME Why American Society of Mechanical Engineers (ASME) ?  History of Establishing Codes and Standards  Started in 1800’s with Boiler Code  International Reputation for Acceptable Standards  Great need for mechanical engineers in industry ASME BPE 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, welding inspections, testing, and certifications. BPE Standards Committee Voluntary Consensus Standard Developed and maintained by a bal