BPE 2009 BIOPROCESSING EQUIPMENT PDF

Buy ASME BPE: BIOPROCESSING EQUIPMENT from SAI Global. The next edition of this Standard is scheduled for publication in This Standard represents the work of the BPE Standards Committee and includes the follow- ASME BIOPROCESSING EQUIPMENT COMMITTEE. ASME BPE Supplement. Supplement to Bioprocessing Equipment. Amendment by ASME International, 05/19/ This document is an amendment.

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Process Gas System Design? Compendial Water Pump Seals? Metallic Materials of Construction? 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? Meets 3 times annually to: The most extensive revision to date! New Process Systems Design Requirements!

New Supplier Certification Program!

Certificate of Authorization issued to qualified component suppliers. Program is starting with tubing and fitting manufacturers. I Inspector Delegates t D l t 4 levels of qualification: New Design Criteria for Hygienic Clamps. New Nominal one inch fitting design. New acceptance criteria for passivated product contact surfaces?

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New Application Data Sheet for seal specification? New section on seals for i l f compendial water pumps. Steaming for bioburden control?

Guidelines for Cleaning Vessels? One facility has to be accepted by: Equipment size is generally staying about ll t i b t the same size or getting smaller. Resistance to steam and corrosives?

ASME BPE Guidelines for Pharmaceutical Equipment

End Users just expect fittings, tubing, and valves to meet the standards. 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.

ASME BPE 修改说明介绍_图文_百度文库

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: ASME BPE has emerged as the definitive international standard on bioprocessing equipment and facilities, covering the subjects ofmaterials, design, fabrication, inspections, testing, and certification.

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This presentation will summarize the bbioprocessing BPE resources and requirements for the design and delivery of components and bio;rocessing 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.