ASME BPE : 2016

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Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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BIOPROCESSING EQUIPMENT

Publisher: American Society of Mechanical Engineers

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Available Formats: PDF - English - DRM, Hardcopy - English
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Specifies requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place (CIPd) and/or steamed in place (SIPd) and/or other suitable processes used in the manufacturing of biopharmaceuticals.

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The purpose of this Part is to identify metallic materials considered acceptable for use in hygienic service. It identifies material specifications, grades and alloys, matching filler metals, fabrication guidelines, and other attributes necessary for this service. It also specifies the data that must be submitted to the MM Subcommittee for any new or unlisted alloy that is proposed for inclusion in Part MM..

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Published
Document Type	Standard
Status	Superseded
Publisher	American Society of Mechanical Engineers
Pages
ISBN
Supersedes	ASME BPE : 2014
Superseded By	ASME BPE : 2019

Standards Referenced By This Book - (Show below) - (Hide below)

PIP PHSMV042 : 2017	HYGIENIC PLASTIC DIAPHRAGM VALVE DESCRIPTIONS
PIP PHSMV029 : 2017	HYGIENIC STAINLESS STEEL OTHER VALVE DESCRIPTIONS
AAMI TIR 43 : 2011	ULTRAPURE DIALYSATE FOR HEMODIALYSIS AND RELATED THERAPIES
ASME STP-PT-065 : 2013	BRANCH LEG STUDY FOR BIOPROCESSING EQUIPMENT
PIP PHSMV026 : 2017	HYGIENIC STAINLESS STEEL BALL VALVE DESCRIPTIONS
ASME PTB 2 : 2009	GUIDE TO LIFE CYCLE MANAGEMENT OF PRESSURE EQUIPMENT INTEGRITY
PIP PHSMV027 : 2017	HYGIENIC STAINLESS STEEL BUTTERFLY VALVE DESCRIPTIONS
ASME B31.3:2016	PROCESS PIPING
PIP PHSMV047 : 2017	HYGIENIC PLASTIC AND PLASTIC LINED BUTTERFLY VALVE DESCRIPTIONS
ASTM E 3060 : 2016	Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy
ASTM E 2898 : 2014 : REDLINE	Standard Guide for Risk-Based Validation of Analytical Methods for PAT Applications
PIP PHSMV025 : 2015	HYGIENIC STAINLESS STEEL CHECK VALVE DESCRIPTIONS
ASME B31.3 SPANISH : 2010	PROCESS PIPING
PIP PHSMV022 : 2018	HYGIENIC STAINLESS STEEL DIAPHRAGM VALVE DESCRIPTIONS

Standards Referencing This Book - (Show below) - (Hide below)

ASTM E 112 : 2014-02	TEST METHODS FOR DETERMINING AVERAGE GRAIN SIZE
ASME PTC19.3 : 1974	PERFORMANCE TEST CODE - PART 3: TEMPERATURE MEASUREMENT
ASTM B 912 : 2002	Standard Specification for Passivation of Stainless Steels Using Electropolishing
ASME PV CODE 9 : 2017	BOILER AND PRESSURE VESSEL CODE - WELDING, BRAZING, AND FUSING QUALIFICATIONS - QUALIFICATION STANDARD FOR WELDING, BRAZING, AND FUSING PROCEDURES; WELDERS; BRAZERS; AND WELDING, BRAZING, AND FUSING OPERATORS
ASME PV CODE 8 SET : 2013	ASME BOILER AND PRESSURE VESSEL CODE (BPVC) - RULES FOR CONSTRUCTION OF PRESSURE VESSELS (SET)
ASTM A 380 : 2006	Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
ISO 37 : 2017	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF TENSILE STRESS-STRAIN PROPERTIES
ASTM A 967 : 2007-07	SPECIFICATION FOR CHEMICAL PASSIVATION TREATMENTS FOR STAINLESS STEEL PARTS
AWS B2.4 : 2012	SPECIFICATION FOR WELDING PROCEDURE AND PERFORMANCE QUALIFICATION FOR THERMOPLASTICS
IEC 60751 : 2.0	INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
ASTM D 395 : 2016-06	TEST METHODS FOR RUBBER PROPERTY - COMPRESSION SET
ASTM E 230/E230M : 2012-12	SPECIFICATION AND TEMPERATURE-ELECTROMOTIVE FORCE (EMF) TABLES FOR STANDARDIZED THERMOCOUPLES
ASTM D 412 : 2016-12	TEST METHODS FOR VULCANIZED RUBBER AND THERMOPLASTIC ELASTOMERS - TENSION
DVS 2202-1 : 2006	FAULTS IN WELDED JOINTS IN THERMOPLASTIC PLASTICS - FEATURES, DESCRIPTION, EVALUATION
ISO 815-2 : 2014	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF COMPRESSION SET - PART 2: AT LOW TEMPERATURES
ASME PV CODE 5 : 2017	BOILER AND PRESSURE VESSEL CODE - NONDESTRUCTIVE EXAMINATION
ASME B46.1 : 2009	SURFACE TEXTURE (SURFACE ROUGHNESS, WAVINESS, AND LAY)
ASME PVHO 1 : 2016	SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY
CFR 21(PTS200-299) : 0	FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
ASTM D 2657 : 2007	PRACTICE FOR HEAT FUSION JOINING OF POLYOLEFIN PIPE AND FITTINGS
ASTM E 1137/E1137M : 2008	SPECIFICATION FOR INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS
ISO 1817 : 2015	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF THE EFFECT OF LIQUIDS
ASTM E 220 : 2013 : REDLINE	Standard Test Method for Calibration of Thermocouples By Comparison Techniques
AWS G1.10M : 0	GUIDE FOR THE EVALUATION OF THERMOPLASTIC WELDS
ASTM E 644 : 2011 : REDLINE	Standard Test Methods for Testing Industrial Resistance Thermometers
ISO 816 : 1983	RUBBER, VULCANIZED - DETERMINATION OF TEAR STRENGTH OF SMALL TEST PIECES (DELFT TEST PIECES)
ASTM D 471 : 2016-02	TEST METHOD FOR RUBBER PROPERTY - EFFECT OF LIQUIDS
ASME B31.3:2016	PROCESS PIPING
AWS QC1 : 2007	STANDARD FOR AWS CERTIFICATION OF WELDING INSPECTORS
ISO 11137 : 1995	STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
ISO 815-1 : 2014	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF COMPRESSION SET - PART 1: AT AMBIENT OR ELEVATED TEMPERATURES
ISO 34-1 : 2015	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF TEAR STRENGTH - PART 1: TROUSER, ANGLE AND CRESCENT TEST PIECES
ASTM E 2500 : 2013 : REDLINE	Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
ISO 48 : 2010	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF HARDNESS (HARDNESS BETWEEN 10 IRHD AND 100 IRHD)
AWS A3.0 : 0	STANDARD WELDING TERMS AND DEFINITIONS - INCLUDING TERMS FOR ADHESIVE BONDING, BRAZING, SOLDERING, THERMAL CUTTING, AND THERMAL SPRAYING
ASTM D 2240 : 2016-01	TEST METHOD FOR RUBBER PROPERTY - DUROMETER HARDNESS
ISO 34-2 : 2015	RUBBER, VULCANIZED OR THERMOPLASTIC - DETERMINATION OF TEAR STRENGTH - PART 2: SMALL (DELFT) TEST PIECES
ASTM D 624 : 2000	TEST METHOD FOR TEAR STRENGTH OF CONVENTIONAL VULCANIZED RUBBER AND THERMOPLASTIC ELASTOMERS

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ASME BPE : 2016

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