ISO 14644-1:2015 introduces the need for particle counters calibrated to ISO 21501-4. The calibration methods assure data accuracy and repeatability. The methods outlined in ISO 14644 and ISO 21501-4 represent an important step in more accurate evaluations of cleanroom contamination and improved process control.
Pharmaceutical products are manufactured to meet exacting standards of both efficacy and quality. All aspects of quality are reviewed considering the risks associated with the delivery method (injected, ingested etc.) and the manner in which they were produced (aseptic, terminally sterilized, or under lesser controlled conditions). This paper looks at two parts of that process: the quality of the environment in which the product is manufactured and the standards that surround the particle concentration limits that determine what a controlled environment consists of.
In August 2020 the normative standard for Europe EN 17141, Cleanrooms and associated controlled environments ā Biocontamination control, was issued. It essentially replaces the existing European Standards (EN) ISO 14698-1:2003 and (EN) ISO 14698-2:2003 within the European Standards community countries, and is associated with the cleanroom standard ISO 14644-1:2015, Cleanrooms and associated controlled environments ā Part 1 Classification of air cleanliness by particle concentration. Globally, ISO 14698 ā1&2:2003 are still valid and applicable.
