DIN, ISO, GMP & Co

The regulatory frenzy sometimes brings forth strange fruit. There is a tuft standard for the brush heads of toothbrushes. Strawberries must have a transverse diameter of at least 18 millimeters to be sold – except for wild strawberries. According to EU specifications, a pizza Margherita should “exude a characteristically aromatic fragrance”. And taking strollers on escalators has been banned since 2010 to protect the child, according to another EU standard – which means moms and dads have to happily lug their strollers up steep stairs.

However, in most cases, standards are useful. They regulate the economy and trade, but also create standards for social coexistence. In Germany, for example, around 24,500 ISO and some 34,000 DIN standards standardize our everyday lives. Among other things, they define requirements for products, services and processes, guarantee quality assurance and create legal certainty.

No cleanroom without standards
In the sensitive area of cleanrooms, standards and guidelines play an indispensable role – after all, particularly high demands are placed on the working environment, processes and employees. Cleanrooms are therefore not only divided into cleanroom classes, there are also many standards that ensure uniform standards and maximum cleanliness in the cleanroom.

The most important are DIN EN ISO 14644-1, the EU-GMP Guideline and VDI Guideline 2083. Anyone who works in and with cleanrooms has inevitably heard of this or dealt with it.

DIN EN ISO 14644-1
The DIN standard ISO 14644-1 defines the degree of purity of air. The ISO classification is based on the particle concentration per cubic meter.
The highest purity has ISO class 1, the lowest ISO class 9.

By the way: DIN stands for German Institute for Standardization (Deutsches Institut für Normung), EN for European Standard and ISO for International Organization for Standardization. DIN EN ISO thus states that the standard is recognized in Germany, in Europe and internationally.

EU-GMP Guideline
The GMP Guideline (“Good Manufacturing Practice”) is mainly used in laboratories and in the pharmaceutical sector. The GMP guideline is binding for the manufacture of sterile drugs, but it is also used in other areas. The guideline defines the classification of cleanliness classes via microbiological contamination and maximum particle values of the air into the four levels A to D. Compliance with the quality requirements is monitored by the competent authorities of the federal states.

VDI Guideline 2083
The set of rules VDI 2083 is the result of the guideline work of the VDI (Association of German Engineers). It is based on ISO 14644 and further elaborates on the guidelines contained therein.

Published: May 2023