Pharmaceutical

Any form of compressed air will contain particles of contaminants. These can stop a pneumatic system from functioning as it should and may lead to production quality issues. These will tend to occur if the process air comes into contact with the product. Various types of contaminant are possible, with the ambient air or intake air susceptible to contamination with almost any kind of particle insert including pollen, dust, hydrocarbons, or heavy metals such as lead, cadmium, or mercury. DIN EN ISO and EU GMP guidelines define, based on cleanroom classes [Fig. 1], how many and what size of particles may be present in a given room. No account is taken of how particle concentrations in the compressor increase significantly when compressed air is generated. During blow-off from a pneumatic system, there may (though not necessarily) be direct contact with the product. And this may result in contamination of formulas due to the extremely high particle density involved.