Regulators encourage the use of restricted access barrier system (RABS) or isolator technologies. Such settings minimize direct human intervention in a process, reducing the risk of microbial ingress from operators. Transition from a classic design based on grade-A or grade-B cleanrooms to an upgraded facility is not to be taken lightly. Such a project would…
How can the effectiveness of isolator systems and Restricted Access Barrier Systems (RABS) be evaluated in a specific production environment before and after implementation? Evaluating the effectiveness of isolator systems and Restricted Access Barrier Systems (RABS) in a production environment requires a detailed and systematic approach, both before the systems are put into place and…
A buoyancy test is required in cleanroom Laminar Airflow Systems (LAFs) to ensure proper airflow and contamination control. Cleanrooms are designed to maintain extremely low levels of airborne particles, and LAF systems play a critical role by providing a continuous, unidirectional flow of filtered air. The buoyancy test helps in verifying the following: Airflow Patterns:…
Clean Room Pressure Cascades When considering pressures cascades, consider a design concept to have a “clean corridor” or a “dirty corridor” design ,typically, low moisture drugs such as tablets or capsules are dry and dusty, therefore more likely to be a significant cross-contamination risk. If the “clean” area pressure differential were positive to the corridor,…
