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  • VDI 2083 Blatt 13.3:2010-10

    Current The latest, up-to-date edition.

    Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications

    Available format(s):  Hardcopy, PDF

    Language(s):  German - English

    Published date:  01-10-2010

    Publisher:  Verlag des Vereins Deutscher Ingenieure

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    Table of Contents - (Show below) - (Hide below)

    Preliminary note
    Introduction
    1 Scope
    2 Terms and definitions
    3 Abbreviations
    4 Water qualities for
      pharmaceutical use
    5 Production of water for
      pharmaceutical use
    6 Storage and distribution
    7 Technical requirements
    8 Project handling and
      qualification
    9 Operation
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides the various tasks and methods of cleanroom technology for ensuring compliance with these requirements are described by the Technical Committee for Cleanroom Technology of the VDI Society Civil Engineering and Building Services (GBG) in the series of guidelines under the generic number VDI 2083, giving heed to the compatibility with the specifications of international standards, particularly those of the ISO 14644 series.

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

    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Current
    Supersedes

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

    VDI 2083 Blatt 17:2013-06 Cleanroom technology - Compatibility of materials with the required cleanliness
    VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    VDI 2083 Blatt 4.2:2011-04 Cleanroom technology - Energy efficiency
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    VDI 2083 Blatt 7:2015-10 Cleanroom technology - Ultrapure media - Quality, supply, distribution

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

    DIN 11865:2012-02 STAINLESS STEELS FITTINGS FOR ASEPTIC, CHEMICAL AND PHARMACEUTICAL INDUSTRY - TEES, ELBOWS AND REDUCERS FOR WELDING ON
    DIN 11850:2009-02 STAINLESS STEEL TUBES FOR THE FOOD AND CHEMICAL INDUSTRIES - DIMENSIONS, MATERIALS
    VDI 2083 Blatt 11:2008-01 Cleanroom technology - Quality assurance
    DIN 11864-1:2016-10 (Draft) STAINLESS STEEL COMPONENTS FOR ASEPTIC APPLICATIONS IN THE CHEMICAL AND THE PHARMACEUTICAL INDUSTRIES - PART 1: CONNECTIONS
    DVS 2212-1:2015-12 Qualifi cation testing of plastics welders - Qualification Test Groups I and II
    VDI 2519 Blatt 2:2001-12 Tender/performance specification for the use of conveyance and storage systems
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    DIN EN 287-1:2011-11 QUALIFICATION TEST OF WELDERS - FUSION WELDING - PART 1: STEELS
    VDI 2083 Blatt 10:1998-02 Cleanroom technology - High-Purity/Ultra-High-Purity (HP-/UHP-)media supply systems
    VDI 2083 Blatt 4.2:2011-04 Cleanroom technology - Energy efficiency
    VDI 2083 Blatt 13.2:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Microelectronics and other technical applications
    VDI 2083 Blatt 12:2000-01 Cleanroom technology - Safety and environmental aspects
    VDI 2083 Blatt 13.1:2009-01 Cleanroom technology - Quality, production and distribution of ultrapure water - Fundamentals
    VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    ISO 10931:2005 Plastics piping systems for industrial applications Poly(vinylidene fluoride) (PVDF) Specifications for components and the system
    EN ISO 1127:1996 Stainless steel tubes - Dimensions, tolerances and conventional masses per unit length (ISO 1127:1992)
    DIN EN ISO 1127:1997-03 STAINLESS STEEL TUBES - DIMENSIONS, TOLERANCES AND CONVENTIONAL MASSES PER UNIT LENGTH
    DIN 11864-2:2016-10 (Draft) STAINLESS STEEL COMPONENTS FOR ASEPTIC APPLICATIONS IN THE CHEMICAL AND THE PHARMACEUTICAL INDUSTRIES - PART 2: FLANGE CONNECTIONS
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    VDI 2083 Blatt 16.1:2010-08 Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
    ASTM E 2500 : 2013 : REDLINE Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment
    DIN EN 10204:2005-01 Metallic products - Types of inspection documents; German version EN 10204:2004
    VDI 2083 Blatt 14:2008-04 (Draft) Cleanroom technology - Airborne molecular contamination (AMC) in cleanrooms
    DIN 11864-3:2016-10 (Draft) STAINLESS STEEL COMPONENTS FOR ASEPTIC APPLICATIONS IN THE CHEMICAL AND THE PHARMACEUTICAL INDUSTRIES - PART 3: CLAMP CONNECTIONS
    VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
    EN 10204:2004 Metallic products - Types of inspection documents
    DVGW W 294-3 : 2006 UV DISINFECTION EQUIPMENT FOR WATER SUPPLY SYSTEMS - PART 3: MEASURING WINDOWS AND SENSORS FOR MONITORING UV DISINFECTION EQUIPMENT - REQUIREMENTS, TESTING AND CALIBRATION
    VDI 2083 Blatt 7:2015-10 Cleanroom technology - Ultrapure media - Quality, supply, distribution
    DVGW W 294-1 : 2006 UV DISINFECTION EQUIPMENT FOR WATER SUPPLY SYSTEMS - PART 1: DESIGN AND CONSTRUCTION, FUNCTION AND OPERATION
    VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
    DVGW W 294-2 : 2006 UV DISINFECTION EQUIPMENT FOR WATER SUPPLY SYSTEMS - PART 2: TESTING (CONSTRUCTION, FUNCTION AND EFFICIENCY)
    VDI 2083 Blatt 5.2:2008-10 Cleanroom technology - Cleanroom operation - Decontamination of multiple-use cleanroom clothing
    EN ISO 10931:2005/A1:2015 Plastics piping systems for industrial applications - Poly(vinylidene fluoride) (PVDF) - Specifications for components and the system (ISO 10931:2005/FDAM 1:2015)
    DIN EN ISO 10931:2015-11 PLASTICS PIPING SYSTEMS FOR INDUSTRIAL APPLICATIONS - POLY(VINYLIDENE FLUORIDE) (PVDF) - SPECIFICATIONS FOR COMPONENTS AND THE SYSTEM (ISO 10931:2005 + AMD 1:2015)
    VDI 2519 Blatt 1:2001-12 Procedures for the compilation of tender and performance specifications
    ISO 1127:1992 Stainless steel tubes Dimensions, tolerances and conventional masses per unit length
    EN 287-1:2011 Qualification test of welders - Fusion welding - Part 1: Steels
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