ASME BPE is an international standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by the American National Standards Institute (ANSI). The first edition of the standard was . This ASME Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical and personal-care products industries, as well as other applications with relatively high levels of hygienic requirements.
It covers materials, design, fabrication, inspections, testing and . The ASME BPE Certification Program is unique in the worl having resulted from widespread industry requests for standardization.
It is the leading standard on how to design and build equipment and systems used in the production of biopharmaceuticals. It incorporates current best-practices for enhancing product purity . This self-study course is designed to be taken at your convenience and on your own schedule. You have days to finish the course from the time of purchase. The ASME BPE Standard covers directly or indirectly the subjects of materials, surface requirements, design for cleanability and sterility, component manufacture, . Bright finished tubes and fittings are closed with transparent PE caps and are individually sealed in PE foil. The tubes and fittings as well as the batch label on the foil contain the information ASME BPE SF1.
Electropolished tubes and fittings are closed with yellow PE caps and are indi- vidually sealed in PE foil.
Author information: (1)W. Designing and building a pharmaceutical facility requires the owner, engineer of recor and constructor to be knowledgeable with regard to the industry codes and . This post will go into some more detail. Life Sciences Industry p. Most of us have some familiarity with the ASME BPE Standard. While you may know of the ASME BPE and you may even know a little bit about the details, you should also know that the Standard is a living document that is constantly evolving to provide the best possible requirements for equipment and . Outside Diameter (mm), Wall- Thickness (mm), Nominal Outside Diameter, Nominal Wall Thickness, Dimensional Standard. ASME Bioprocessing Equipment ( BPE ) Certification is a company level certification for organizations manufacturing or supplying tubing and fittings under the scope of the ASME standard Bioprocessing Equipment, which dictates specific conditions for design, materials, construction, surface finish and inspection.
Raccorderia ASME – BPE e sanitaria. I componenti sono disponibili in dimen-. Validation challenges the entire “System” for compliance according to good engineering practices, engineering specifications, process integrity and product quality. Using ASME BPE standards is critical for component and system validation according to cGMP and FDA requirements.
ECE applies ASME BPE and provides . Harrison Electropolishing follows common industry standards set forth by ASTM, SEMI and ASME in its electropolish and passivation treatments. ASME – BPE is the leading standard on how to design and build equipment for bioprocessing, pharmaceuticals and personal care products. Call us or request a quote today!
Type A ASME – BPE Standard 1” Hygienic Clamp Fitting. All hygienic clamp-fitting designs in use in the U.
Since that patent ran out, there have been many applications developed for this fitting design and it is seen in every sanitary installation . Tubes and fittings in this range comply with ASME . Tri-Clover UltraPure ASME BPE tubes. The committee nominates members to be .