This presentation will summarize the new BPE resources and requirements for the design and delivery of components and process systems for use in bioprocessing, pharmaceutical, and personal care product industries. Milton, Alfa Laval J. OE Group 6 group. It is the aim of the Society to provide recognition of organizations so authorized. Elbich, Exigo Manufacturing R.
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Marks, P. ASME BioProcessing Equipment standard or ASME BPE 1 ASME BPE Scope This Standard deals with the requirements of the bioprocessing, pharmaceutical, and personal care product industries as well l d ti d t i ll as other applications with relatively high levels of hygienic requirements, covering directly or indirectly the subjects of materials, design, fabrication, inspections, testing, and certification.
CIP Distribution Systems? Process Gas System Design? Hygienic Pump Design? CIP Skid Design? Single-Use Product Requirements? Compendial Water Pump Seals?
Polymer Surface Finishes? Metallic Materials of Construction? Corrosion Testing? Elastomer Performance? Hygienic Hose Assemblies? Process Instrumentation? Developed and maintained by a balanced group of experts? Multiple stages of approval before publication? Continuously updated to support y p p industry accepted practices? The most extensive revision to date! New Process Systems Design Requirements!
New Sections! New Supplier Certification Program! Certificate of Authorization issued to qualified component suppliers. Program is starting with tubing and fitting manufacturers. New Design Criteria for Hygienic Clamps. New Nominal one inch fitting design.
New acceptance criteria for passivated product contact surfaces? New Application Data Sheet for seal specification? New section on seals for i l f compendial water pumps. New Design Content? Hygienic Pumps? Spray De ices? Spra Devices? Ball Valves? O-ring connections? Top-entering mixers? Steaming for bioburden control? New Process Systems? CIP Distribution? Flow Rate Guidelines? Guidelines for Cleaning Vessels? Spray Device Design? Project 2.
One facility has to be accepted by: — Several operating companies — Several regulatory agencies from around the globe. Equipment size is generally staying about ll t i b t the same size or getting smaller.
Resistance to steam and corrosives? End Users just expect fittings, tubing, and valves to meet the standards. Science-Based Requirements q? Not too restrictive or expensive? Updated regularly to reflect the current acceptance criteria. Go to a meeting and listen to the Subcommittee Sessions.
Determine where your technical strengths would help. Participate in a Task Group. Speak up and be an active participant in the Subcommittee Sessions. Should I become a member? If you have the time and interest to be y an active participant.
If you want to vote on changes and updates to an international standard. You may also contact after the meeting at: David. Marks dmealliance. Jay Ankers? Rick Zinkowski? ASME BPE has emerged as the definitive international standard on bioprocessing equipment and facilities, covering the subjects of , materials, design, fabrication, inspections, testing, and certification.
This presentation will summarize the new BPE resources and requirements for the design and delivery of components and process systems for use in bioprocessing, pharmaceutical, and personal care product industries. This publication will include new content on the design of process systems such as bioreactors, fermentors, autoclaves, process gasses, CIP distribution and single-use equipment.
New resource material will be provided on electropolishing, passivation, elastomer performance, metallic materials of construction, polymer surface finishes, corrosion testing and stainless steel rouge. The BPE has also been expanded to include new sections on process instrumentation, hygienic pumps, hygienic hose assemblies and rotary spray devices.
What is ASME BPE Standard 2009
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 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.