ISO 14644‑1 Overview and Recent Revision

ISO 14644‑1 Overview and Recent Revision

The ISO 14644‑1 standard (2015 edition) is the global benchmark for cleanroom air cleanliness, defining nine classes (ISO Class 1–9) based on airborne particle counts. Each class sets maximum concentrations of particles ≥0.1, 0.2, 0.3, 0.5, 1.0, or 5.0 μm in a cubic meter of air. In practice, lower class numbers mean cleaner environments. For example, ISO Class 5 (used in … Read more

Nonconformity During Audit and its types with Examples

Nonconformity finding in pharmaceuticals during Audit is a very crucial stage, where finding non-conformity becomes a hurdle for the organization. Nonconformity may be major or minor types it depends on what type of process is affecting at what level. What is Nonconformity As per ISO 19011 “Nonconformity” means non-fulfillment of a requirement, against ISO 9001 … Read more

Complete Overview of ISO CleanRoom Classification and Risk Assessment

ISO CleanRoom Classification is done to define the limit of particles as per the standardized or predetermined criteria. A cleanroom is one where the viable count and particle count are kept within predetermined and standardized ranges. These rooms must always be kept at the specified level of cleanliness, as their name suggests, and cleaning is … Read more