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 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
Air changes in pharmaceutical cleanrooms play a significant role in maintaining the cleanroom quality as per ISO CleanRoom Classification through the HVAC system. Air change per hour is the number of total replacements of any room air in one hour. if the supply of air by the HVAC system in one houres is equal to … Read more
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