Standards are continuously being developed and supplemented with the latest research expertise and experience to ensure the standardised description of processes and specifications in cleanroom technology across industries and countries. In addition to the ISO 14644 standards, the VDI 2083 guidelines are also frequently used to describe the state of the art and to classify parameters and limit values. In our blog post, we present both series of guidelines and look at their correlations as well as their differences.
To be able to categorise clean production in cleanrooms according to their criteria, parameters and requirements as well as their specific air cleanliness and qualification, the cleanrooms themselves, but also the individual clean areas, installations and, above all, the processes affecting the cleanroom must be included. All factors such as room planning, air technology, surface cleanliness, cleaning, local cleanroom facilities and staff clothing are included in the assessment alongside classification and qualification.
Both the ISO 14644 series of guidelines and VDI 2083 are divided into individual parts or sheets and focus on the assessment of cleanroom areas and their standardisation aspects. Both documents make an important contribution to quality assurance. Whether for determining the ISO class of cleanrooms and associated cleanroom areas, minienvironments, SD modules or operating equipment (cleanroom suitability), contamination is always an issue.
The developed ISO 14644 standard covers the planning, operation and monitoring of cleanrooms, cleanroom areas and cleanroom technology as well as processes directly related to these. This international standard has been largely adopted into national standards by almost all countries.
The important thing to remember with the national versions of this standard is that translations can never rule out the possibility that wording has changed. For example, in the Russian version GOST R ISO 14644, formulations in the subjunctive mood (should, could) have been replaced by a ‘MUST’. This restricts the scope for interpreting the standard and therefore makes the solution to be realised more expensive.
The ISO 14644 family of standards is divided into various parts. The following table provides an insight into the first 5 parts of DIN EN ISO 14644 (extract from the German version). The entire tables (ISO 14644 and subsequently VDI 2083) can be found in our whitepaper ‘Standardisation of VDI 2083 and ISO 14644’.
Part 1 of the ‘Classification of air cleanliness based on particle concentration’ was completely revised and published as ISO 14644-1:2015 in December 2015. This Part 1 of the standard for determining cleanroom classes or air cleanliness based on airborne particles is the only decisive factor for the validity of the ISO class determined for the cleanroom, as a whole series of particle concentration measurements and approaches have changed compared to the previous version.
According to this standard, the classes from microelectronics to pharmaceuticals are determined on the basis of airborne particles. In the pharmaceutical and other industries, for example, the EU GMP guidelines are also used in the manufacture of sterile medicines, where microbiological contamination is also assessed. In addition to the assessment of air purity, the surfaces and the microorganisms on them are also analysed.
Part 1: Classification of air cleanliness based on particle concentration
Part 2: Monitoring to demonstrate cleanroom performance in terms of air cleanliness based on particle concentration for continued compliance with ISO 14644-1
Part 3: Test methods
Part 4: Planing, execution and initial commissioning
Part 5: Operation
The VDI 2083 guidelines are the result of the work carried out by the VDI (Association of German Engineers). The VDI guidelines describe the current state of the art. They are based on ISO 14644 and expand on the guidelines contained therein. Within the VDI 2083 set of rules, COLANDIS has contributed to a large number of individual sheets and is thus constantly developing them further. The following list is an extract from VDI 2083.
VDI 2083 Part 1: Particulate air cleanliness classes
VDI 2083 Part 2: Specification for testing and monitoring continuous compliance with the requirements
VDI 2083 Part 3: Metrology
VDI 2083 Part 3.1: Metrology in cleanroom air – Monitoring
VDI 2083 Part 4.1: Planning, Construction and start-up of cleanrooms
VDI 2083 Part 4.2: Energy efficiency
The most significant difference between the two sets of rules DIN EN ISO 14644 and VDI 2083 is their depth. Not just because the 2083 series of guidelines has more pages than ISO 14644, but also because many aspects are considered in more detail in VDI 2083.
The VDI 2083 guideline series, which is based on ISO 14644, presents the cleanroom topic in more details in each individual sheet without contradicting the ISO 14644 guideline series. The VDI guideline can be seen as a kind of supplement to the ISO guidelines, as it also deals with topics such as energy and cost efficiency as well as industry-specific aspects that receive little attention in the ISO regulations. Even though the VDI 2083 guideline provides more detailed information than ISO 14644, both guidelines are regarded as absolutely equivalent standards in cleanroom technology.
While ISO 14644 is considered an international standard, the VDI guidelines are only nationally orientated. ISO 14644 is almost always used for basic questions on the classification of cleanrooms and clean areas, although VDI 2083 describes this topic in exactly the same way. This means that you are always on the safe side when communication shifts to the international level.
It should also be pointed out at this point that ISO 14644 and VDI 2083 are subject to constant revision and adaptation. It is necessary to work with the latest versions. In addition, the numbering of the individual sheets in VDI 2083 has been adapted to the numbering of ISO 14644.
And finally, it should also be pointed out here again that the US Federal Standard 209E (US FED STD) with its purity classes 1; 10; 100; 1,000; 10,000 and 100,00 was officially withdrawn back in 2001 and is NO longer valid. However, knowledge of this can still be very helpful in technical discussions in the USA and other countries.
Would you like to read more about standardisation in cleanrooms? Then simply download our free whitepaper ‘Standardisation VDI 2083 and ISO 14644’!