Customer Support: +1 416-401-8730

Login to i2i Subscription Intertek.com
  • There are no items in your cart
Please enter a keyword to search
Advanced search

VDI 2083 Blatt 16.1:2010-08

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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Withdrawn date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

08-01-2010

Publisher

Verlag des Vereins Deutscher Ingenieure

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Withdrawn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
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

View more information
US$176.73
Excluding Tax where applicable
USD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - German - English
PDF - German - English
Hardcopy - German - English
PDF - German - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.

Learn more on subscription solutions

or

Get in touch with us