VDI 2083 Blatt 16.1:2010-08
Withdrawn
Cleanroom technology - Barier systems (isolators, mini-environments, separative devices) - Effectiveness and certification
Hardcopy , PDF
German - English
08-01-2010
02-02-2024
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
This guideline provides information for the planning, production/installation, commissioning and operation of barrier systems in clean room technology.
| DevelopmentNote |
Supersedes VDI 2083-16. (09/2010)
|
| DocumentType |
Standard
|
| Pages |
80
|
| PublisherName |
Verlag des Vereins Deutscher Ingenieure
|
| Status |
Withdrawn
|
| Supersedes |
| 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 |
| 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 |
| 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 |
| 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 |
| EN ISO 14644-7:2004 | Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) (ISO 14644-7:2004) |
| 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 (ISO 14644-3:2005) |
| VDE 1000:2017-04 | GENERAL PRINCIPLES FOR THE SAFE DESIGN OF PRODUCTS |
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