Do you meet the requirements of ISO 16890?

Due to the large number of processes that take place in closed environments in the pharmaceutical industry, proper air filtration is vital to prevent a multitude of contamination problems. Within the pollutants we find different types that have different effects and consequences. The penetration capacity of the particles is greater the smaller their size is. Fractions PM10, PM2.5 and PM1 are some of the most dangerous ones.

Until now, depending on the location of the projects, a different regulation had to be consulted in reference to the levels of particles, being ASHRAE 52.2 the reference in the USA and EN 779 the standard in Europe, with the well-known classification from G1 to F9 (HEPA and ULPA filters are not affected). But a standardization of the regulations has made it possible to unify criteria, while improving the environmental conditions in classified rooms. This new standard is ISO 16890.

ISO 16890 came into force in August 2018. Although, to this day, it is still unknown to many.

What are the advantages of ISO 16890?

• A single reference worldwide.
• More exhaustive tests that will ensure better air quality:
  • Different particle sizes are tested on the same filter using DEHS aerosol (between 0.3 µm and 1 µm) or KCI (2.5 µm and 10 µm).
  • Includes an electrostatic discharge of the filter complete with IPA vapor.
  • Efficiency is obtained as a mean of the treated and untreated filter.

Filters are classified into 4 groups based on the most prominent particle fractions:

1. ISO Coarse (Coarse Powder): retains less than 50% of 10 µm particles
2. ISO ePM10: retains more than 50% of 10 µm particles
3. ISO ePM2.5: retains more than 50% of 2.5 µm particles
4. ISO ePM1: retains more than 50% of 1 µm particles

The filter identification must be accompanied by the retention for particles of a determined size, which must be at least 50%. The efficiency index (which is this %) can be defined in intervals of 5, and can be set between 50% and 95%.

• Example:

All of the above allows a more specific and realistic selection that meets the interior quality requirements of each case and the quality of the existing exterior air.

At Klinea we are already familiar with these new regulations, and you, what are you waiting for?

*Picture source: Camfil*