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 meets the required standard and is demonstrated to be maintained within "normal" operating conditions.