Particle Contamination in High-Purity Process Chemicals
ISO/DTR 14644 -21:2023 Cleanrooms and associated controlled environments

The Technical Committee (ISO/TC209) responsible for ISO 14644, the set of Standards governing cleanrooms and associated controlled environments, looked at the need for a new document to aid users in the application of airborne particle counters; especially considering the new revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) describes the application of particle counters for classification and monitoring to provide sufficient proof that the cleanroom performance both meets the required standard and is demonstrated to be maintained within ‘normal’ operating conditions.

Airflow Visualization
Airflow Visualization Studies: The Impact of Annex 1 (2022) on Sterility Assurance

Understanding critical air patterns and their impacts is paramount to controlling an environment and is a crucial activity in adhering to the relevant regulations. Scientific demonstration is the basis of pharmaceutical GMP regulatory compliance, and the best way to demonstrate air patterns is through airflow visualization studies (also known as smoke studies). If unidirectional airflow (UDAF) is used as a tool for mitigating the risk of contamination, a company must demonstrate its effectiveness through such studies.