New Regulations Concerning Airborne Particle Counters (ISO 21501 And ISO 14644)Source: Hach Company - Particle Counting Division
By Bob Latimer
In May, 2007, the International Standards Organization (ISO) introduced a new standard for the calibration of air and liquid particle counters. This new standard, ISO 21501, incorporates a number of new tests that are designed to reduce count variability between different instruments. Specifically, the standard specifies that counting resolution and counting efficiency tests be performed at routine calibration cycles, typically every six months. In 2011, ISO21501 compliant calibrations for air particle counters will become mandatory for aseptic filling under EU-GMP Annex 1 and FDA cGMP Guidance.
In preparation for this new standard, in late 2005 when the ISO 21501 standard was still in draft, Hach Company incorporated the standard’s performance criteria within the specifications for all air particle counter development projects. In addition, a technical audit was conducted of the entire product portfolio and where practical, existing product designs were enhanced to comply with the new standard.