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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
02-02-2024
German - English
01-08-2010
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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Withdrawn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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