Here are the links to the main GMP guidelines compiled.
Individual guidelines can be viewed and downloaded for free.

- FDA cGMP Guidelines
- International GMP Guidelines
- GMP and GDP Guidelines
- Pharmacopoeias (Drug Books)

The guidelines marked with * from industry associations as well as the pharmacopoeias of the EP (Europe) and USP (USA) are, however, available for purchase from the respective organizations at a cost.

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This edition is the result of a systematic revision and includes changes in response to feedback from users and experts, which was evaluated as part of an international survey. The title has been changed to "Classification of Air Purity Based on Particle Concentration" to achieve consistency with other parts of the standard. The nine ISO purity classes have been retained unchanged; however, Table 1 now specifies the particle concentration for various particle sizes within the nine integer classes.

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The international standard was developed within ISO/TC 209 "Cleanrooms and associated controlled environments" in collaboration with CEN/TC 243 "Cleanroom technology." In DIN, the responsible committee was Working Committee 2.21/2.22 "Normal mirror body ISO/TC 209 and CEN/TC 243" of the NHRS Working Committee 2.21 "Cleanroom technology."
This part of the International Standard ISO 14644 contains the requirements for the operation of cleanrooms and associated controlled environments at the necessary cleanliness levels. Neither the cleanliness levels nor the methods to achieve them are specified. Additional guidance is provided in the annexes of the standard.
The standard is intended for planners and operators of cleanrooms.

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In the design and specification as well as in the operation and regulation of cleanrooms and other related cleanroom areas, factors beyond the classification of surface cleanliness should be considered. These factors are discussed in more detail in other parts of ISO 14644 and ISO 14698. This part of ISO 14644 provides a classification for determining and specifying cleanliness levels based on particle concentrations on a surface. This part of ISO 14644 also introduces some test methods and procedures for determining the particle concentration on surfaces.

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This part of the ISO 14644 series establishes the classification system for surface cleanliness in cleanrooms concerning the presence of chemical compounds or elements (including molecules, ions, atoms, and particles). This part of the ISO 14644 series applies to all solid surfaces in cleanrooms and associated cleanroom areas, such as walls, ceilings, floors, work areas, tools, equipment, and devices.

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This standard provides guidance on selecting cleaning procedures to achieve specified levels of cleanliness. When choosing a procedure, aspects related to surface description, purity specifications, types of contamination, cleaning techniques, material compatibility, and evaluation methodology should be considered. Most procedures are suitable for the simultaneous removal of more than one category of contamination; therefore, a general standard for selecting a cleaning method is necessary for contamination by particles as well as chemicals. The standard addresses the cleaning of cleanroom surfaces, equipment surfaces within a cleanroom, and material surfaces in a cleanroom up to a specified level. It provides guidance on evaluating cleaning procedures to achieve the required classes of particulate surface cleanliness and chemical surface cleanliness, and regarding which techniques should be considered to attain these specified levels.

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This standard links the classification of air cleanliness based on the particle concentration of the cleanroom with the suitability of equipment for use in cleanrooms and associated cleanroom areas. It establishes a methodology for assessing the suitability of equipment (such as machines, measuring devices, process equipment, components, tools) for use in cleanrooms and related cleanroom areas concerning airborne particle cleanliness according to the specifications in ISO 14644-1. The particle size range extends from 0.1 µm to equal or greater than 5 µm (as specified in ISO 14644-1).

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This standard contains requirements and guidelines for assessing the chemical airborne purity of equipment and materials intended for use in cleanrooms and associated controlled environments, which are related to the ISO standard for cleanliness classes based on chemical concentration (see ISO 14644-8).

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Diese Norm bietet einen Leitfaden und Empfehlungen für die Optimierung des Energieeinsatzes und Aufrechterhaltung der Energieeffizienz in neuen und bestehenden Reinräumen, reinen Bereichen und SD-Modulen. Die Norm bietet eine Anleitung für die Gestaltung, den Bau, die Inbetriebnahme und den Betrieb von Reinräumen. Sie enthält alle reinraumspezifischen Merkmale und kann in verschiedenen Bereichen angewendet werden, um den Energieeinsatz in der Elektronik, Luft- und Raumfahrt, Nuklear, Pharma, Krankenhaus, Medizingeräte und Lebensmittelindustrie sowie für andere Reinluftanwendungen zu optimieren. Darüber hinaus führt die Norm das Konzept des Benchmarkings für die Leistungsbeurteilung und den Vergleich der Energieeffizienz von Reinräumen ein, während die Anforderungen der Performance Levels von ISO 14644 eingehalten werden.

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This part of the ISO 14644 standards provides guidelines for the interpretation and application of the results of measuring the particle deposition rate (PDR) on one or more sensitive surfaces of a cleanroom as part of a contamination control program. It offers guidance on how the PDR can be influenced and how to reduce the risk of particle contamination on sensitive surfaces.

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This document sets out the requirements, recommendations, and methodologies for microbiological contamination control in cleanroom environments. Furthermore, this document specifies the requirements for the preparation and documentation of microbiological control in cleanroom environments. This document is limited to viable microbiological contamination and excludes considerations of endotoxin, proteinaceous infectious agents, and viral contamination.

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Publisher: VDI Society for Building and Building Services Engineering
Available in: German

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Release Date: 1996-02
Withdrawal Date: 2007-12
Replacement Document: VDI 2083 Part 4.1; VDI 2083 Part 5.1
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Specialist Department Technical Building Equipment
Related Handbooks: VDI Handbook Medical Technology; VDI Handbook Indoor Air Technology
Number of Pages: 27
Available in: German, English

The document applies in particular in conjunction with Part 1 of this guideline and contains information on achieving and maintaining the necessary air purity classes. It covers, among other things, conceptual, technical, structural measures, assembly, commissioning, operation and maintenance, cleaning.

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Publication Date: 2015-04
Publisher: VDI Society Building and Building Services
Author: VDI Technical Department for Building Services Engineering
Related Manuals: VDI Handbook Cleanroom Technology
Number of Pages: 10
Available in German, English

This guideline specifies requirements for the regular testing of a cleanroom or controlled environment to demonstrate ongoing compliance. These requirements relate to the functional tests described in VDI 2083 Part 1 and VDI 2083 Part 3 as well as DIN EN ISO 14644-1 and DIN EN ISO 14644-3 for the operation of the systems. The described functional tests include visual inspection, measurement of air velocity or airflow rate and air change rate of the rooms, filter leak test, determination of pressure difference at the filter and between rooms, classification of air cleanliness, determination of recovery time, measurement of temperature, relative humidity, sound pressure level, and illuminance.

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Release Date: 2005-07
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of Pages: 40
Available in: German, English

This document applies to measuring procedures and measuring devices related to acceptance testing and monitoring of operational cleanroom technology systems. Separate standards and guidelines apply to the testing of individual components of cleanroom technology systems. The methods described here are specifically tailored to the requirements of cleanrooms and therefore differ from measurement procedures for other technical systems.

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Publication date: 2012-06
Publisher: VDI Society Building and Building Services
Author: VDI Technical Department for Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of pages: 37
Available in: German, English

This guideline addresses the continuous plant-related measurement monitoring of individual parameters of cleanroom technology systems. Monitoring can be continuous (e.g., pressure, temperature, humidity) or sequential (e.g., microbiology). The guideline applies to so-called classic monitoring in the sense of continuous parameter surveillance, but not to recurring measurements for qualification. The guideline does not include a description of microbiological investigations. Procedures for conducting measurements on cleanroom technology systems are specified, and suitable measuring devices are described to establish them as standards for monitoring. The requirements for monitoring measurements aim to assist users in selecting methods that enable the detection of plant- and process-related deviations from operational requirements. This guideline does not apply to the monitoring of cleanrooms with data loggers that merely store the recorded data and are read out at intervals. Data loggers that transmit the recorded data directly to a higher-level system and are therefore strictly operated only as sensors are not excluded.

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Release Date: 1996-02
Revision Date: 2007-12
Replacement Document: VDI 2083 Part 5.1; VDI 2083 Part 9.1
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook on Indoor Air Quality
Number of Pages: 51
Available in: German, English

The document covers the planning, creation, maintenance, restoration, and verification of the required cleanliness on surfaces in clean areas. It includes the classification of surface cleanliness, the requirements for cleanliness and the associated usability of surfaces; the procedures for cleaning and decontamination of surfaces; and the methods for verifying surface cleanliness.

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Release Date: 2011-04
Publisher: VDI Society Building and Building Services
Author: VDI Technical Department for Technical Building Equipment
Associated Manual: VDI Manual Cleanroom Technology
Number of Pages: 59
Available in German, English

This guideline describes cleanroom-specific energy-saving potentials. The processes running in the cleanroom are only considered at the interfaces to the cleanroom-specific technical building equipment in this guideline. As an example, the guideline examines the potential savings in ultrapure water and pure steam. Naturally, building architecture, technical building equipment (TGA) for the surrounding area, the building's central energy supply, and all possibilities for heat recovery are also part of a comprehensive energy assessment. Since these areas are extensively described in existing standards (e.g., VDI 2067, VDI 3807, DIN V 18599), only the interfaces to the cleanroom are considered here.

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Release date: 1996-02
Retirement date: 2007-12
Replacement document: VDI 2083 Part 5.1
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook on Indoor Air Quality
Number of pages: 20
Available in: German, English

The guideline contains health-related requirements for the comfort of individuals during light activity (1.5 met) in cleanrooms. Human thermal comfort depends on the body's heat balance and the local distribution of heat emission. The heat balance is determined by personal parameters, such as physical activity level (activity grade) and clothing (thermal resistance), as well as by parameters of the surrounding climate, namely enclosure surface temperature, air temperature, relative humidity, and air velocity.

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Publication date: 2007-09
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Department of Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of pages: 95
Available in: German, English

The guideline describes requirements for the operation of cleanroom technology systems, which are specified within the framework of quality assurance to ensure the respective cleanliness requirements of the process environment. The scope of application includes all plannable and foreseeable operating states. It covers, in addition to the cleanroom process and the production process, normal operation, standby operation, disturbances, as well as disturbance elimination and maintenance measures. The cleanliness requirements should encompass all contamination categories relevant to the specific application: physical (particles), chemical (molecular), and biological. Emergency situations, such as disasters and fires, are not within the scope of application.

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Release Date: 2008-10
Withdrawal Date: 2017-01
Replacement Document: VDI 2083 Part 9.2
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of Pages: 8
Available in: German, English

This guideline applies to cleanroom clothing intended for multiple uses. Disposable cleanroom clothing, which is disposed of after use, is not covered by this guideline.

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Release date: 1996-11
Revocation date: 2007-04
Replacement document: VDI 2083 Part 15
Publisher: VDI Society Building and Building Technology
Author: VDI Specialist Department Technical Building Equipment
Related Handbooks: VDI Handbook Indoor Air Quality
Number of pages: 15
Available in: German, English

Personnel in cleanrooms are among the critical sources of contamination. Particulate contamination originates partly from the respiratory tract and is released in droplet form during speaking, exhaling, and sneezing through the mouth and nose, and partly from the skin surface and clothing. The document provides guidance on how to minimize these contaminations and their spread in the room through personnel selection (medical, personal suitability criteria), clothing (workplace-related requirements), and behaviors (methodical training and further education, personnel monitoring). The discussion of such measures, which aim to keep the possible disruptive influences of the "contamination factor human" within defined limits, is the purpose of this guideline.

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Release Date: 2015-10
Publisher: VDI Society Building and Building Technology
Author: VDI Department of Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of Pages: 76
Available in German, English

The guideline addresses the specification of pure media (steam, gases, and chemicals) for processes in cleanroom technology as well as the distribution systems for such media. The guideline provides a summary of knowledge regarding the planning, construction, operation, and monitoring of pure media supply systems, and supports planners, system suppliers, and operators in their work. It is intended as a replacement for VDI 2083 Part 7 and Part 10.

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Release date: 2002-09
Withdrawal date: 2007-12
Replacement document: VDI 2083 Sheet 9.1
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook on Room Air Technology
Number of pages: 24
Available in: German, English

The document includes the definitions of cleanroom suitability and, based on that, the assessment of the suitability of equipment for use in cleanrooms and associated cleanroom areas. The aim of this guideline is to provide a standardized procedure for qualifying or comparing equipment (using a statistical analysis of the results) regarding their airborne particle emissions. Equipment can include, by way of example in accordance with VDI 2815 Sheet 5, production facilities (filling plants), measurement and testing equipment (microscopy), transport and handling devices (conveyor belts), storage facilities, and interior furnishings. Cleanroom suitability is part of the overall cleanliness suitability.

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Release Date: 2014-10
Publisher: VDI Society Building and Building Technology
Author: VDI Technical Department for Technical Building Equipment
Related Manuals: VDI Manual Cleanroom Technology
Number of Pages: 56
Available in: German, English

This guideline deals with the chemical contamination of clean rooms. It describes the phenomenology, measurement, and control of air contamination caused by chemicals, i.e., gaseous contamination. The guideline is aligned with the standard DIN EN ISO 14644-8, which classifies airborne chemical contamination (formerly called AMC), but does not specify its measurement or control.

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Release date: 1991-09
Withdrawal date: 2007-05
End of objection period: 1992-03-31
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Department of Technical Building Equipment
Related Handbooks: VDI Handbook on Indoor Air Quality; VDI Handbook on Sanitary Engineering
Number of pages: 40
Available in: German

The purpose of the guideline is to summarize knowledge regarding the planning, construction, operation, and monitoring of pure water systems. Key statements in the guideline are based on findings from weakness analyses of existing pure water systems and their extension to future tasks.

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Release Date: December 2006
Publisher: VDI Society Building and Building Technology
Author: VDI Technical Department for Building Services
Related Manuals: VDI Handbook Cleanroom Technology
Number of Pages: 60
Available in German, English

This guideline serves for planning, producing, maintaining, restoring, and verifying the required cleanliness suitability of operating equipment as well as HVAC components in clean areas according to VDI 2083 Sheet 1. The document primarily addresses particulate contaminants. Chemical (molecular), biological, and radiological surface contaminants are not the specific focus of this guideline; the same applies to process media. This guideline includes the definition of cleanliness suitability and, based on that, the classification, as well as procedures for determining the suitability of operating equipment and HVAC components for use in rooms, whose air cleanliness and other parameters are assessed through regulations. Furthermore, the guideline describes the outgassing and electrostatic properties of operating equipment and their associated cleanroom HVAC components. Surface cleanliness and its classification are also covered in this guideline. The cleanliness suitability of an operating device includes all process-relevant contaminants. The measurement methods described in this guideline for assessing the cleanliness suitability of operating equipment include cleanroom suitability, particulate surface cleanliness, outgassing behavior, and electrostatic behavior. This guideline applies to operating equipment introduced into the cleanroom as well as to HVAC components.

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Release Date: 2017-01
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Building Services Engineering
Related Handbooks: VDI Handbook Cleanroom Technology
Number of Pages: 116
Available in: German, English

This guideline applies to all consumables used in cleanliness-controlled areas, e.g., gloves, clothing, shoes/overshoes, packaging materials, cleaning agents, masks, paper. The guideline describes the fundamental properties of the mentioned product types as well as their cleanliness-related characteristics and testing. Particulate and airborne chemical contaminants are the main focus. Additionally, this guideline provides information on selecting products according to industry and process requirements, as well as logistics considerations.

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Release Date: 1998-02
Retirement Date: 2015-10
Replacement Document: VDI 2083 Part 7
Publisher: VDI Society for Building and Civil Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Manuals: VDI Handbook Cleanroom Technology
Number of Pages: 26
Available in: German, English

Pure media (chemicals and gases) are increasingly used for many production purposes. They are used in clean technologies such as semiconductor manufacturing, solar technology, fiber optics, micromechanics, and similar industries. The goal is to prevent the purity from deteriorating, or only allowing it to deteriorate within an acceptable range, between the media supply point (Point of Supply/P.O.S.) and the point of entry at the consumer (Point of Entry/P.O.E.). The purpose of this guideline is to compile knowledge regarding the planning, construction, operation, monitoring, and documentation of pure media supply systems. Purity refers to contamination with particles, cations, anions, TOC, and other specific parameters (foreign gases, humidity, etc.). No specific purity requirements are provided; these must be defined in relation to the respective applications with the operator.

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Release Date: 2008-01
Retirement Date: 2013-01
Replacement Document: VDI 2083 Sheet 1
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Manuals: VDI Handbook Cleanroom Technology
Number of Pages: 36
Available in: German, English

The VDI 2083 guideline series defines cleanliness classes for the planning, construction, and operation of cleanroom technology systems and outlines ways to achieve and maintain them. In this guideline, based on the ISO 9000 series standards, the key quality parameters relevant for all areas of cleanroom technology are defined, and necessary quality assurance measures are described. The general statements of ISO 9004 are adopted unless explicitly stated otherwise, and are commented on according to their importance in cleanroom technology, with necessary additions relevant to practical application in this field.

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Release Date: 2000-01
Publisher: VDI Society Building and Building Services
Author: VDI Technical Department for Building Services Engineering
Related Manuals:
- VDI Manual Management and Safety in Environmental Technology
- VDI Manual Cleanroom Technology
Page Count: 13
Available in German, English

The document supplements the VDI 2083 Sheet 2 guideline with those safety- and environment-related measures necessary to control cross-system impacts. Due to the variety of different products, processes, activities, and structural conditions in cleanrooms, this guideline sheet presents a guide with general instructions on procedures for new construction, renovation, and dismantling, as well as for decommissioning or expansion. Proper disposal of plant components and consumables is also addressed.

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Release date: 2009-01
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Department of Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of pages: 59
Available in: German, English

The purpose of this guideline is to summarize knowledge regarding the planning, construction, operation, and monitoring of water treatment systems for the production and distribution of ultrapure water. This guideline applies to the quality requirements, production, and supply of ultrapure water for processes with high purity demands, as used in cleanroom technology. Similar processes and systems are used in power plant technology and nuclear power plant technology, but these are not covered by this guideline, as they are described elsewhere. Ultrapure water is used in various applications, on the one hand for cleaning processes and on the other hand for diluting concentrated ultrapure chemicals to working solution concentrations, or it becomes part of the final product. For example, contaminated surfaces are cleaned with ultrapure water before carrying out sensitive work processes. The ultrapure water used for this purpose must meet high requirements regarding particulate, chemical, and biological purity during application. In the field of microelectronics/semiconductor technology, the focus, due to the miniaturization of structures, is on removing as many particulate, chemical, and biological contaminants as possible. In the life sciences, the main focus is on removing microbial and particulate contamination and reducing ion load and organic substances to a specified limit. In biotechnology, especially for molecular biology, contamination is reduced similarly to microelectronics/semiconductor technology and pharmaceutical water, but other impurities, such as enzymes and nucleic acids, may also play a role. These are not further addressed here, as they are regulated elsewhere. It is important to consider the relevant national and international regulations in the life sciences sector. The ultrapure water systems used can be structured into: preparation including pretreatment, storage and distribution, and use including quality monitoring. The necessary process steps for ultrapure water production and thus the system design are determined by the raw water analysis, influenced by local conditions, and the specific ultrapure water quality target analysis for the application. Environmental conditions, such as the requirement to reduce chemical use, as well as local costs for water and other operating expenses, also influence the selection of individual process steps. Storage and distribution are determined by local installation conditions and the connected usage units. In general, it is necessary to develop an economical solution from a variety of possible options.

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Release Date: 2009-01
Publisher: VDI Society Building and Building Services
Author: VDI Department of Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of Pages: 52
Available in: German, English

The purpose of this guideline is to summarize the knowledge regarding the planning, construction, operation, and monitoring of water treatment systems for the production and distribution of ultrapure water. This guideline applies to the quality requirements, production, and supply of ultrapure water for processes with high purity demands, as used in cleanroom technology. Similar processes and systems are used in power plant technology and nuclear power plant technology; however, these are not covered by this guideline, as they are described elsewhere. Ultrapure water is used in various applications, on the one hand for cleaning processes and, on the other hand, for diluting concentrated ultrapure chemicals to usable solution concentrations, or it becomes part of the product to be manufactured. For example, contaminated surfaces are cleaned with ultrapure water before sensitive work processes are carried out. High requirements regarding particulate, chemical, and biological purity are imposed on the ultrapure water used for these purposes. In the field of technical applications, especially in microelectronics/semiconductor technology, the focus, due to the miniaturization of structures, is on removing as many particulate, chemical, and biological contaminants as possible. The ultrapure water systems used are structured into: preparation including pretreatment, storage and distribution, and utilization including quality monitoring. The necessary process steps for ultrapure water production and thus the system design are determined by the raw water analysis, which is influenced by local conditions, and the specific ultrapure water quality target analysis for the application. Environmental technical conditions, such as the requirement to reduce chemical use, as well as local costs for water and other operational expenses, also influence the selection of individual process steps. Storage and distribution are determined by local installation conditions and the connected usage units. In general, a cost-effective solution must be developed from a variety of possible options.

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Publication date: 2010-10
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of pages: 104
Available in: German, English

This guideline applies to the quality requirements, production, and supply of ultrapure water for processes with high purity demands. Similar processes and systems are used in power plant technology and nuclear power plant technology; however, these are not covered by this guideline as they are described elsewhere.

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Release Date: 2008-04
Withdrawal Date: 2009-07
End of objection period: 2008-09-30
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Manuals: VDI Manual on Indoor Air Quality
Number of pages: 32
Available in: German

This guideline addresses the effects of chemical contamination on people in cleanrooms, as well as on raw materials and products manufactured or stored there, and auxiliary materials. The guideline establishes general principles for the treatment, handling, prevention, and reduction of chemical contamination in cleanrooms. These principles are based on the performance characteristics of known and available technical solutions, as well as on the economic aspects of these solutions. It is explicitly pointed out that media other than air can also carry contaminants affecting processes, products, and humans. These include, in particular, water, aqueous solutions, other process fluids, and process gases. The chemical contamination of these media impacts all affected manufacturing industries, e.g., microelectronics, optics, food and beverage, pharmaceuticals, biotechnology, and medical technology. The molecular contamination of liquid and gaseous process media, however, is not covered by this guideline. The scope of this guideline includes all production and storage areas of affected industries under cleanroom conditions, where products and processes can be influenced by chemical contamination.

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Release Date: 2007-04
Publisher: VDI Society for Building and Civil Engineering
Author: VDI Department for Technical Building Equipment
Related Manuals: VDI Manual for Cleanroom Technology
Number of Pages: 38
Available in German, English

The guideline VDI 2083 Sheet 15 covers the following points:
– The cleanroom-related requirements for personnel and their clothing
– Training, behavior in the cleanroom, success control
– Particulate contamination caused by personnel / cleanroom clothing, training, workplace design

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Release Date: 2009-06
Revocation Date: 2010-08
Replacement Document: VDI 2083 Sheet 16.1
End of objection period: 2009-11-30
Publisher: VDI Society Building and Building Technology
Author: VDI Department for Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of Pages: 46
Available in: German

This guideline deals with all types of barrier systems for the separation of defined clean environments. The scope includes: classification of contaminations – from the perspective of hazard analysis – across different substances; classification of isolated clean environments; ensuring continuous operation of isolated clean environments – monitoring – limit value monitoring – control and regulation technology; criteria for isolated clean environments (isolators, workbenches); qualification procedures for barrier systems; decontamination and cleaning of barrier systems; transfer systems and disposal at the interfaces of barrier systems; operation and observation of barrier systems. The scope of this guideline covers: any kind of special delimitation between space and process environment, from the outlet for low-turbulence displacement airflow in operating rooms to mini-environments in semiconductor technology or isolators in pharmaceuticals, with the aim of contamination control; all types of contamination, i.e., particulate (see also VDI 2083 Sheet 1 and Sheet 3 as well as EN ISO 14644-1, -2, and -3), chemical/molecular (see also VDI 2083 Sheet 8.1 as well as EN ISO 14644-8), and biological contamination (see also VDI 2083 Sheet 18). VDI 2083 Sheet 16 is intended as a practically relevant supplement and explanation to EN ISO 14644-7. The scope of this guideline is limited to gaseous media such as air and protective gases within the enclosure/barrier, but not vacuum processes or liquid media. It deals exclusively with airborne contaminants, meaning that only air (exceptions for special atmospheres e.g., protective gases in the case of isolators, inerting, decontamination media) is considered as the carrier medium. The penetration of leaks or weaknesses/defects by microbiological contaminants is not addressed. Safety-related aspects, such as the leakage of liquids or gases from barrier units, are not considered.

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Release date: 2010-08
Publisher: VDI Society Building and Building Services
Author: VDI Technical Building Equipment Department
Related Handbooks: VDI Handbook Cleanroom Technology
Number of pages: 80
Available in: German, English

This guideline provides information for the planning, production/installation, commissioning, and operation of barrier systems in cleanroom technology. Planners, manufacturers, users, and operators of clean work areas must define and document the requirements for the product and its environment. The scope of this guideline covers any type of special separation between the room and process environment that serves contamination control; this includes both dynamic and fixed barriers. All types of contamination (particulate and chemical/molecular, biological) are addressed. The guideline complements DIN EN ISO 14644-7 regarding practical application.

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Release date: 2015-10
End of objection period: 2016-03-31
Publisher: VDI Society Building and Building Technology
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology
Number of pages: 16
Available in German

This guideline addresses all types of mini-environments for isolating defined pure controlled environments in technical areas. This guideline applies exclusively to gaseous media such as air and protective gases within the mini-environment. It does not apply to vacuum processes or liquid process media. It deals exclusively with airborne contaminants, meaning that air (or in special cases a special atmosphere, e.g., protective gas) is generally considered as the carrier medium. The penetration of microbiological contaminants through leaks or weaknesses/defects is not considered.

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Release Date: 2013-06
Publisher: VDI Society Building and Building Services
Author: VDI Technical Department for Building Equipment
Related Manuals: VDI Handbook Cleanroom Technology
Number of Pages: 71
Available in German, English

The guideline addresses particulate and chemical (molecular) contaminants and electrostatic properties of materials, as well as the cleanability of surfaces. Biological and radiological surface contamination are not specifically covered by this guideline. The guideline includes the definition of purity suitability and cleanroom suitability of materials. Based on this, classification and procedures for determining suitability for use in clean production areas are outlined.

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Publication Date: 2012-01
Publisher: VDI Society for Building and Building Technology
Author: VDI Technical Department for Technical Building Equipment
Related Manual: VDI Manual on Cleanroom Technology
Number of Pages: 32
Available in German, English

The guideline describes the origins and possible consequences of microbiological contamination in the air and on surfaces in cleanrooms, as well as the detection, quantification, prevention, and control of bio-contamination. The guideline establishes general principles for the treatment, handling, prevention, and reduction of microbiological contamination in cleanrooms. The aim of the guideline is to provide operators of hygienic production processes under cleanroom conditions with decision-making aids for establishing optimized control concepts against microbiological contamination according to the state of the art.

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Publication Date: 2018-08
Publisher: VDI Society Building and Building Services
Author: VDI Technical Department for Building Services Engineering
Related Manuals: VDI Manual Cleanroom Technology
Number of Pages: 51
Available in German, English

This guideline establishes a procedure for testing and classifying the airtightness of containments, typically cleanrooms, air ducts, but also comparable systems and parts, and provides guidance on the construction of airtight cleanrooms. The procedure is also applicable, by analogy, to other rooms whose airtightness needs to be tested.

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Publication Date: 2018-06
Publisher: VDI Society Building and Building Technology
Author: VDI Technical Building Equipment Department
Related Handbook: VDI Handbook Cleanroom Technology
Number of Pages: 14
Available in German, English

The guideline provides information on evaluating and optimizing the selection of materials that need to be decontaminated by gas. Suitable decontamination agents include, for example, hydrogen peroxide, ethylene oxide, chlorine dioxide, and formaldehyde. The guideline describes a characterization of the desorption behavior of a chemical compound as a material property, in order to derive a fundamental influence on the ventilation behavior of a room. Applying the guideline helps to optimize the ventilation times of a room through targeted selection of materials that absorb little of a chemical compound during gas treatment and quickly desorb it during ventilation. Material durability, aging processes, periodic repetitions, and extreme loads with the chemicals used are not considered in this guideline.

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Publication Date: 2019-10
Publisher: VDI Society Building and Building Technology
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook Medical Technology
              VDI Handbook Cleanroom Technology
Number of Pages: 108
Available in German, English

This guideline provides a practical aid based on a risk-based approach for identifying critical contaminants of biological, chemical, or particulate nature, as well as, if applicable, for establishing acceptance criteria (purity assessment) and for verification (purity determination) of medical devices during the manufacturing process. This applies to both the medical devices themselves and their intermediate products, supplied products, etc. This guideline does not cover the initial processing and reprocessing of medical devices at the user site, nor the assessment of the biological compatibility of medical devices (biocompatibility according to the standards in the ISO 10993 series).

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Possible publication date: 2023-04
Publisher: VDI Society Building and Building Services Engineering
Author: VDI Technical Department for Technical Building Equipment
Related Handbooks: VDI Handbook Cleanroom Technology

Objective/Application Area: Normative specification of a fast, robust, and low-effort measurement method compared to the current state, with an expanded measurement range. The guideline is intended to build on the analysis according to ISO 16000-6 and to focus on the measurement methodology to ensure the comparability of measurement results. For this purpose, it should specify sampling, transport, and handling, as well as the determination of the blank value.

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Possible publication date: 2023-04
Publisher: VDI Society Building and Building Technology
Author: VDI Department for Technical Building Equipment
Related Manuals: VDI Manual Cleanroom Technology

Objective/Application Area: Normative specification of a procedure for measuring/determining surface contamination, methodology for establishing verifiable criteria for the surface cleanliness of supplied parts.

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Release Date: 2017-08
Publisher: VDI Society for Production and Logistics
Author: VDI Technical Logistics Department
Related Handbooks: VDI Handbook of Technical Logistics - Volume 1: Cranes
Number of Pages: 40
Available in: German, English

Movable energy and data transmission systems are required for the operation of crane systems. They enable safe communication of the electrical/electronic controls and sensors integrated into the crane with each other, between cranes operating on the same crane runway, with stationary control stations, and with central control systems. This guideline compiles the significant systems for energy and data transmission for cranes based on technical criteria and classifies and evaluates them for different application areas in crane systems. Systems from hydraulic or pneumatic plants, as well as the specific requirements of shelving systems, gantry technology, cleanroom conditions, offshore use, and personnel transport systems, are not considered.

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Publication date: 2018-06
Publisher: VDI Society Technologies of Life Sciences
Author: VDI Department of Biotechnology

Related Handbooks:
VDI Handbook Biotechnology
VDI Handbook Factory Planning and Operation - Volume 1: Operational Monitoring/Maintenance
VDI Handbook Factory Planning and Operation - Volume 2: Modeling and Simulation
VDI Handbook Medical Technology
VDI Handbook Process Engineering and Chemical Engineering - Volume 2: Planning/Design

Number of pages: 48
Available in: German, English

The guideline is a practical aid for interdisciplinary projects in the GMP environment. The guideline helps to plan GMP-regulated projects and construction activities, as well as their subsequent operation, in an interdisciplinary manner from the beginning. It is intended for suppliers, machinery and plant manufacturers, planners, consultants, and operators of GMP-regulated areas/projects (in the pharmaceutical industry, cosmetics industry, medical technology in hospitals, and biotechnology sector).

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Publication Date: 2019-05
Deadline for objection period: 2020-01-31
Publisher: VDI Society for Technologies of Life Sciences
Author: VDI Department of Biotechnology

Related Manuals:
VDI Manual Biotechnology
VDI Manual Medical Technology
VDI Manual Process Engineering and Chemical Engineering - Volume 2: Planning/Design

Number of pages: 38
Available in: German

The guideline formulates fundamental rules of good data management in the field of life sciences research and is aimed at organizational responsible persons for the collection and processing of digital data in connection with research-oriented activities. The application of this guideline facilitates the reuse of scientific results, provides clarity of action for those responsible (performers and clients), supports compliance with guidelines from funding agencies and scientific publishers, and can also serve as an initial overview of relevant standards in this field.

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