TECHHUB

Do you comply with ISO 16890?

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

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

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

What advantages does ISO 16890 provide?

  • 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 a full filter electrostatic discharge with IPA vapor.
  • Efficiency is obtained as an average of the treated and untreated filter.

The filters are classified into 4 groups based on the most notable 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 the determined size, which must be at least 50%. The effectiveness index (which is this %) can be defined in intervals of 5 by 5, and can be set between 50% and 95%.

  • Example:
CodificationMeaning
ePM10 70%70% retention of particles with a size equal to or less than 10 µm

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

At Klinea we have already become familiar with this new regulation and you, what are you waiting for?