Pharmaceutical, biotechnology, food and beverage, personal care and other hygienic product manufacturers are broadly regulated and therefore must comply with national and international laws, regulations, codes and industry standards. ASME BPE (American Society of Mechanical Engineers: Bioprocessing Equipment) approval applies to companies manufacturing or supplying hygienic equipment. It specifies conditions for design, materials, fabrication, surface finish, and inspection.
ASME BPE compliance for manufacturers within the hygienic industries ultimately translates into a license to manufacture. Achieving a license to manufacture requires that the applicant undertake qualification and commissioning activities upon which validation is built. Validation challenges the entire system to meet the standards of good engineering practices, engineering specifications, process integrity and product quality. ASME BPE standards are critical to achieve component and system validation, per cGMP and FDA requirements.