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    ASME BPE : 2016

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s):  Hardcopy, PDF

    Superseded date:  05-06-2019

    Language(s):  English

    Published date:  14-10-2016

    Publisher:  American Society of Mechanical Engineers

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    Abstract - (Show below) - (Hide below)

    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.

    Scope - (Show below) - (Hide below)

    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..

    General Product Information - (Show below) - (Hide below)

    Document Type Standard
    Publisher American Society of Mechanical Engineers
    Status Superseded
    Superseded By
    Supersedes

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

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

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

    ISO 815-2:2014 Rubber, vulcanized or thermoplastic Determination of compression set Part 2: At low temperatures
    CFR 21(PTS200-299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 200-299
    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
    ISO 815-1:2014 Rubber, vulcanized or thermoplastic Determination of compression set Part 1: At ambient or elevated temperatures
    ASME B31.3:2016 PROCESS PIPING
    DVS 2202-1:2006-07 Imperfections in thermoplastic welding joints - Features, descriptions, evaluation
    ASTM E 644 : 2011 : REDLINE Standard Test Methods for Testing Industrial Resistance Thermometers
    ASME B46.1 : 2009 SURFACE TEXTURE (SURFACE ROUGHNESS, WAVINESS, AND LAY)
    ISO 34-1:2015 Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
    ASTM A 380 : 2006 Standard Practice for Cleaning, Descaling, and Passivation of Stainless Steel Parts, Equipment, and Systems
    ASME PTC19.3 : 1974(R2004) PERFORMANCE TEST CODE - PART 3: TEMPERATURE MEASUREMENT
    ASME PVHO 1 : 2016 SAFETY STANDARD FOR PRESSURE VESSELS FOR HUMAN OCCUPANCY
    AWS B2.4 : 2012 SPECIFICATION FOR WELDING PROCEDURE AND PERFORMANCE QUALIFICATION FOR THERMOPLASTICS
    AWS A3.0 : 0 STANDARD WELDING TERMS AND DEFINITIONS - INCLUDING TERMS FOR ADHESIVE BONDING, BRAZING, SOLDERING, THERMAL CUTTING, AND THERMAL SPRAYING
    ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    AWS QC1 : 2007 STANDARD FOR AWS CERTIFICATION OF WELDING INSPECTORS
    ASTM E 220 : 2013 : REDLINE Standard Test Method for Calibration of Thermocouples By Comparison Techniques
    IEC 60751:2008 Industrial platinum resistance thermometers and platinum temperature sensors
    ASME PV CODE 5 : 2017 BOILER AND PRESSURE VESSEL CODE - NONDESTRUCTIVE EXAMINATION
    ASME PV CODE 8 SET : 2013 ASME BOILER AND PRESSURE VESSEL CODE (BPVC) - RULES FOR CONSTRUCTION OF PRESSURE VESSELS (SET)
    ISO 37:2017 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    AWS G1.10M:2016 GUIDE FOR THE EVALUATION OF THERMOPLASTIC WELDS
    ISO 34-2:2015 Rubber, vulcanized or thermoplastic Determination of tear strength Part 2: Small (Delft) test pieces
    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
    ASTM B 912 : 2002 Standard Specification for Passivation of Stainless Steels Using Electropolishing
    ISO 1817:2015 Rubber, vulcanized or thermoplastic Determination of the effect of liquids
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