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  • VDI 2083 Blatt 16.1:2010-08

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  02-02-2024

    Language(s):  German - English

    Published date:  01-08-2010

    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 Specification of barrier types
    4 Process requirements
    5 Characterization of contaminants
    6 Planning/construction
    7 Operation
    Annex A - Checklist: Process
              requirements for URS/risk
              analysis/planning/operation
    Annex B - Checklist: Routine test of
              safety workbenches
    Annex C - Glove testing, particularly
              for pharmaceutical isolators
    Annex D - Sample acceptance report
              for mini-environments
    Annex E - Qualification of personal
              protection isolators
    Annex F - H[2]O[2] decontamination in
              barrier systems - Synopsis
              of the relevant international
              standards and guidelines
    Annex G - Synopsis of the standards
              and guidelines pertaining to
              the determination of the
              leak rate of barrier systems
    Annex H - Examples of testing personal
              and product protection - Overview
              of examples of metrological
              verification methods
    Annex I - Qualification of aseptic
              isolators
    Annex J - Checklist for specifications
              regarding the routine
              operation of aseptic
              pharmaceutical isolators
              in particular
    Bibliography

    Abstract - (Show below) - (Hide below)

    This guideline provides information for the planning, production/installation, commissioning and operation of barrier systems in clean room technology.

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

    Development Note Supersedes VDI 2083-16. (09/2010)
    Document Type Standard
    Publisher Verlag des Vereins Deutscher Ingenieure
    Status Withdrawn
    Supersedes

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

    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
    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 18:2012-01 Cleanroom technology - Biocontamination control
    VDI 2083 Blatt 13.3:2010-10 Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications

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

    DIN EN ISO 14644-1:2016-06 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 1: CLASSIFICATION OF AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-1:2015)
    VDI 2083 Blatt 11:2008-01 Cleanroom technology - Quality assurance
    DIN 31000 : 1979 GENERAL PRINCIPLES FOR THE SAFE DESIGN OF PRODUCTS
    VBG 4 : 1997 ELECTRICAL EQUIPMENT AND OPERATING EQUIPMENT
    VDE 0810-1 : 2005 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND SOFTWARE REQUIREMENTS
    IEC 61511-1:2016+AMD1:2017 CSV Functional safety - Safety instrumented systems for the process industry sector - Part 1: Framework, definitions, system, hardware and application programming requirements
    DIN EN ISO 14644-3:2006-03 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    ISO 14644-2:2015 Cleanrooms and associated controlled environments Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
    VDI 2083 Blatt 3:2005-07 Cleanroom technology - Metrology and test methods
    VDI 2083 Blatt 1:2013-01 Cleanroom technology - Particulate air cleanliness classes
    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
    DIN EN ISO 14644-2:2016-05 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 2: MONITORING TO PROVIDE EVIDENCE OF CLEANROOM PERFORMANCE RELATED TO AIR CLEANLINESS BY PARTICLE CONCENTRATION (ISO 14644-2:2015)
    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 13.3:2010-10 Cleanroom technology - Quality, production, and distribution of ultrapure water - Pharmacy and other life-science applications
    DIN EN 1779:1999-10 NON-DESTRUCTIVE TESTING - LEAK TESTING - CRITERIA FOR THE METHOD AND TECHNIQUE SELECTION
    VDI 2083 Blatt 4.1:2006-10 Cleanroom technology - Planning, construction and start-up of cleanrooms
    VDI 2083 Blatt 8.1:2014-10 Cleanroom technology - Air cleanliness chemical concentration (ACC)
    VDI 2083 Blatt 15:2007-04 Cleanroom technology - Personnel at the clean work place
    EN 1779:1999/A1:2003 NON-DESTRUCTIVE TESTING - LEAK TESTING - CRITERIA FOR METHOD AND TECHNIQUE SELECTION
    VDI 1000:2017-02 VDI Standardisation Work - Principles and procedures
    EN 420:2003+A1:2009 Protective gloves - General requirements and test methods
    DIN EN 374-2:2015-03 PROTECTIVE GLOVES AGAINST DANGEROUS CHEMICALS AND MICRO-ORGANISMS - PART 2: DETERMINATION OF RESISTANCE TO PENETRATION
    ISO 14644-3:2005 Cleanrooms and associated controlled environments Part 3: Test methods
    DIN EN 420:2010-03 PROTECTIVE GLOVES - GENERAL REQUIREMENTS AND TEST METHODS
    DIN EN 12469:2000-09 BIOTECHNOLOGY - PERFORMANCE CRITERIA FOR MICROBIOLOGICAL SAFETY CABINETS
    EN 374-2:2014 Protective gloves against dangerous chemicals and micro-organisms - Part 2: Determination of resistance to penetration
    EN 374-3:2003/AC:2006 PROTECTIVE GLOVES AGAINST CHEMICALS AND MICRO-ORGANISMS - PART 3: DETERMINATION OF RESISTANCE TO PERMEATION BY CHEMICALS
    ISO 14644-7:2004 Cleanrooms and associated controlled environments — Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
    VDI 2083 Blatt 5.1:2007-09 Cleanroom technology - Cleanroom operation
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    VDI 2083 Blatt 7:2015-10 Cleanroom technology - Ultrapure media - Quality, supply, distribution
    BGI 5151 : 2009
    BGR 195 : 2007
    ISO 10648-2:1994 Containment enclosures — Part 2: Classification according to leak tightness and associated checking methods
    BGV A 3 : 1997
    EN ISO 14644-2:2015 Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration (ISO 14644-2:2015)
    EN 12469:2000 Biotechnology - Performance criteria for microbiological safety cabinets
    VDI 2083 Blatt 9.1:2006-12 Clean room technology - Compatibility with required cleanliness and surface cleanliness
    DIN EN 61511-1 : 2005 FUNCTIONAL SAFETY - SAFETY INSTRUMENTED SYSTEMS FOR THE PROCESS INDUSTRY SECTOR - PART 1: FRAMEWORK, DEFINITIONS, SYSTEM, HARDWARE AND SOFTWARE REQUIREMENTS
    VDI 2083 Blatt 3.1:2012-06 Cleanroom technology - Metrology in cleanroom air - Monitoring
    ISO 13408-6:2005 Aseptic processing of health care products Part 6: Isolator systems
    VDI 2083 Blatt 5.2:2008-10 Cleanroom technology - Cleanroom operation - Decontamination of multiple-use cleanroom clothing
    DIN 12980:2016-10 LABORATORY INSTALLATIONS - SAFETY CABINETS AND GLOVE BOXES FOR CYTOTOXIC SUBSTANCES AND OTHER CMR DRUGS
    EN ISO 14644-1:2015 Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration (ISO 14644-1:2015)
    VDI 2083 Blatt 18:2012-01 Cleanroom technology - Biocontamination control
    EN ISO 14644-3:2005 CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS - PART 3: TEST METHODS
    VDE 1000:2017-04 GENERAL PRINCIPLES FOR THE SAFE DESIGN OF PRODUCTS
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