ASME BPE 2007 pdf download

ASME BPE 2007 pdf download.Bioprocessing Equipment.
GR-5.1 Pressure Vessels The responsibilities of the owner’s Inspector shall be the same as the inspector in ASME BPVC, Section VIII, Division 1, UG-91. GR-5.2 Piping, Tubing, and Non-Code Vessels The responsibilities of the owner/user’s inspector shall be in accordance with ASME B31.3, para. 340.2. GR-6 ACCESS FOR INSPECTORS Manufacturers of bioprocessing equipment and com- ponents shall allow free access of owner/user and authorized inspection personnel at all times while work on the equipment or components is being performed. The notification of an impending inspection should be mutually agreed to by the manufacturer and the inspec- tor. Access may be limited to the area of the manufactur- er’s facility where assembly, fabrication, welding, and testing of the specific equipment or components is being performed. Inspectors shall have the right to audit any examination, to inspect componentsusing any examina- tion method specified in the Design Specification (including Purchase Order), and review all certifications and records necessary to satisfy the requirements of GR-5.Themanufacturer shall providetheinspector with work progress updates. GR-7 MANUFACTURER’S QUALITY ASSURANCE PROGRAM Themanufacturershallimplementaqualityassurance program describing the systems, methods, and proce- duresusedtocontrolmaterials,drawings,specifications, fabrication, assembly techniques, and examination/ inspection used in the manufacturing of bioprocessing equipment. GR-8 METRIC Metric units in this Standard are conversions from U.S. Customary units, and are for reference purposes only unless specified otherwise. GR-9 REFERENCES For the purpose of this Standard, the most recent approved version of the following referenced standards shall apply: ANSI/AWS A3.0, Standard Welding Terms and Definitions ANSI/AWS QC-1, Standard for AWS Certification of Welding Inspectors AWS D18.2, Guide to Weld Discoloration Levels on the Inside of Austenitic Stainless Steel Tube 2 Publisher: American Welding Society (AWS), 550 NW Le Jeune Road, Miami, FL 33126 ASME Boiler and Pressure Vessel Code, Section V, Nondestructive Examination ASME Boiler and Pressure Vessel Code, Section VIII, Division 1, Pressure Vessels ASME Boiler and Pressure Vessel Code, Section IX, Welding and Brazing Qualifications ASME B31.1, Power Piping ASME B31.3, Process Piping ASME B46.1, Surface Texture (Surface Roughness, Waviness, and Lay) Publisher: The American Society of Mechanical Engineers (ASME), Three Park Avenue, New York, NY10016;OrderDepartment:22 LawDrive,Box2300, Fairfield, NJ 07007 ASTM A 20/A 20M, Standard Specification for General Requirements for Steel Plates for Pressure Vessels ASTMA182/A182M,SpecificationforForgedorRolled Alloy and Stainless Steel Pipe Flanges, Forged Fittings, and Valves and Parts for High-Temperature Service ASTMA213/A213M,SpecificationforSeamlessFerritic and Austenitic Alloy-Steel Boiler, Superheater, and Heat-Exchanger Tubes ASTM A 269, Seamless and Welded Austenitic Stainless Steel Tubing for General Service ASTM A 270, Specification for Seamless and Welded Austenitic Stainless Steel Sanitary Tubing ASTM A 312/A 312M, Seamless and Welded Austenitic Stainless Steel Pipes ASTM A 351/A 351M, Specification for Castings, Austenitic, Austenitic-Ferritic (Duplex), for Pressure- Containing Parts ASTM A 380, Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems ASTM A 480/A 480M, Specification for General Requirements for Flat-Rolled Stainless and Heat- Resisting Steel Plate, Sheet, and Strip ASTM A 484/A 484M, Specification for General Requirements for Stainless and Steel Bars, Billets, and Forgings ASTM A 666, Specification for Austenitic Stainless Steel Sheet, Strip, Plate, and Flat Bar ASTM A 967, Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts ASTM B 912, Standard Specification for Passivation of Stainless Steels Using Electropolishing ASTM E 112, Test Methods for Determining Average Grain Size Publisher:ASTMInternational(ASTM),100BarrHarbor Drive, P.O. Box C700, West Conshohocken, PA 19428 FDA,21 CFR,Parts210and211,CurrentGoodManufac- turing Practices