What is ASME BPE Standard 2009
ASME BPE standard was first published in 1997 , aims to ensure the production of pharmaceutical equipment , pharmaceutical and personal care products used by the industry to achieve a certain degree of unity and an acceptable level of quality.
The standard is interdisciplinary experts from the material and equipment manufacturers and suppliers, engineering design and installation companies, consulting companies, inspection bodies and equipment consisting of users to develop and co-sponsored by regularly revised. Its cause is that several major biotechnology, pharmaceuticals, engineering companies and equipment suppliers think that this high-purity industry lacks and highly in need of standardized design specifications and manufacturing quality standards.
ASME BPE standard describes the problems associated with the design requirements: aseptic system, component size, materials joint, product contact surface finish, equipment seals, polymer -based materials and basic acceptance criteria. This standard also includes a number of recommended standards of acceptance and inspection template files to help speed up the validation and operation of new facilities.
ASME BPE 2009 Version was published in July 2009 , it covers some new sections, such as: metal used in construction materials, supplier qualification certificate, as well as new non- mandatory appendix , including the question of suitable electro-polishing, corrosion testing, residual iron content, rust and passivation phenomena, etc.
ASME BPE standard applies only to install the new system and the transformation of existing systems, and is not intended for those older devices in the secondary market liquidity, and has no intention of peremptory norms running production systems.
Standardized operation system to ensure public safety is a function of government regulatory agencies. These organizations usually by means of such a standard ASME BPE to ensure the health and manufacturers’ equipment used in personal care products can be safely run, while manufacturers have a responsibility to use a CGMP norm to ensure public safety operation.
The article was collected and revised by WELLGREEN PROCESS SOLUTIONS – Your reliable solution of ASME BPE fittings.