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ASME BPE-2005 Bioprocessing Equipment

Standard Number:  ASME BPE-2005
Title:  Bioprocessing Equipment
Language:  English
Replaced by Standard:  ASME BPE:2007

Status:  Withdrawn
International Classification for Standards (ICS)MATHEMATICS. NATURAL SCIENCES>>Biology. Botany. Zoology
Publisher:  American Society of Mechanical Engineers (ASME)
Number of Pages:130  

Description:Covers the requirements of the bioprocessingindustry, covering directly or indirectly the subjects ofmaterials, design, fabrications, pressure systems (vessels andpiping), examinations, inspections, testing, and certifications,Items or requirements that are not specifically addressed in thisStandard should not be considered prohibited.  
Statements of Policy
Standards Committee Roster
Summary of Changes
Part GR General Requirements
GR-1 Introduction
GR-2 Scope
GR-3 Inspection
GR-4 Inspector/Examiner
GR-5 Responsibilities
GR-5.1 Pressure Vessels
GR-5.2 Piping, Tubing, and Noncode Vessels
GR-6 Access for Inspectors
GR-7 Manufacturer's Quality Assurance Program
GR-8 Metric
GR-9 References
GR-10 Terms and Definitions
Part SD Design for Sterility and Cleanability
SD-1 Introduction
SD-2 Scope and Purpose
SD-3 General Guidelines
SD-3.1 Cleanability
SD-3.2 Sterility
SD-3.3 Surface Finishes
SD-3.4 Materials of Construction
SD-3.5 Fabrication
SD-3.6 Static O-Rings, Seals, and Gaskets
SD-3.7 Connections and Fittings
SD-3.8 Exterior Design
SD-3.9 Containment
SD-3.10 Miscellaneous Design Details
SD-3.11 System Design
SD-3.12 Drainability
SD-4 Specific Guidelines
SD-4.1 Instrumentation
SD-4.2 Speciality Hoses
SD-4.3 Centrifuges
SD-4.4 Filtration Equipment
SD-4.5 Pumps
SD-4.6 Process (Hygienic) Valves
SD-4.7 Vessels, Tanks, Bioreactors, Fermenters,
and Columns
SD-4.8 Agitators and Mixers
SD-4.9 Heat Exchange Equipment
SD-4.10 Cell Disrupters
SD-4.11 High Purity Water and Steam Systems
SD-4.12 WEI Generators and Clean/Pure Steam
SD-4.13 Micro/Ultrafiltration and Chromatography
SD-4.14 Sterilizers/Autoclaves
SD-4.15 CIP Systems and Design
SD-5 Testing and Inspection
SD-5.1 Spray Ball Test
SD-5.2 Sterility/Cleaning Testing
SD-5.3 Hydrostatic Test
SD-5.4 Drainability Test
SD-6 Documentation
SD-7 Responsibilities
Part DT Dimensions and Tolerances for Stainless Steel
Automatic Welding and Hygienic Clamp Tube
Fittings and Process Components
DT-1 Scope
DT-2 Pressure Rating
DT-3 Marking
DT-3.1 Marking Information
DT-3.2 Method of Marking
DT-3.3 Exceptions
DT-4 Materials
DT-5 Metal Thickness
DT-6 Fitting Dimensions
DT-7 Tests
DT-8 Tolerances
DT-9 Welding Ends
DT-10 Hygienic Clamp Ends
DT-11 Heat Treatment
DT-12 Surface Condition
DT-13 Packaging
Part MJ Material Joining
MJ-1 Scope
MJ-2 Materials
MJ-2.1 Stainless Steels
MJ-2.2 Nickel Alloys
MJ-2.3 Mechanically Polished Material
MJ-2.4 Electropolished Material
MJ-2.5 Other Materials
MJ-2.6 Weld and Finish Samples
MJ-3 Joining Processes and Procedures
MJ-3.1 Welds Finished After Welding
MJ-3.2 Welds Used in the As-Welded Condition
MJ-3.3 Nonmetallics
MJ-3.4 Mechanical Connections
MJ-4 Weld Joint Design and Preparation
MJ-4.1 General
MJ-4.2 Pressure Vessels and Tanks
MJ-4.3 Piping
MJ-4.4 Tubing
MJ-5 Filler Material
MJ-6 Weld Acceptance Criteria
MJ-6.1 General
MJ-6.2 Pressure Vessels and Tanks
MJ-6.3 Piping
MJ-6.4 Tubing
MJ-6.5 Sample Welds
MJ-7 Inspection, Examination, and Testing
MJ-7.1 Scope
MJ-7.2 Types of Examinations
MJ-7.3 Examination Procedures
MJ-7.4 Supplementary Examinations
MJ-7.5 Testing
MJ-7.6 Records
MJ-8 Procedure Qualification
MJ-8.1 Pressure Vessels and Tanks
MJ-8.2 Piping
MJ-8.3 Tubing
MJ-9 Performance Qualification
MJ-9.1 Pressure Vessels and Tanks
MJ-9.2 Piping
MJ-9.3 Tubing
MJ-10 Documentation Requirements
MJ-11 Passivation
Part SF Stainless Steel and Higher Alloy Interior
Surface Finishes
SF-1 Scope
SF-2 Objective
SF-3 Applications
SF-4 Material
SF-5 Typical Stainless Steel Interior Surface
Anomaly Characteristics
SF-6 Classification of Interior Surface Finishes
on Weldments for Process Equipment and
SF-7 Inspection and Techniques Employed in the
Classification of Interior Surface Finishes
SF-8 Description of Various Surfaces Available on
Stainless Steel and Higher Alloys
Part SG Equipment Seals
SG-1 Scope and Purpose
SG-1.1 Scope
SG-1.2 Purpose
SG-2 Seal Classes
SG-2.1 Class I Seals
SG-2.2 Class II Seals
SG-2.3 Class III Seals
SG-3 General Provisions for Seals in Bioprocessing
Service: User Basic Design Requirement
SG-3.1 Seal Performance
SG-3.2 System Requirements
SG-3.3 Seal Construction
SG-3.4 Compliance Requirements
SG-3.5 Sealing Systems
SG-4 Special Provisions for Seals in Bioprocessing
SG-4.1 Group 2 (Dynamic Seals)
Nonmandatory Appendix
A Commentary: Slag
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  932KB
Tile in English:  Bioprocessing Equipment

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