RABS

Regulatory Considerations for RABS Implementation

Regulatory Considerations for RABS Implementation

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…

Effectiveness Evaluation of Isolator Systems and Restricted Access Barrier Systems

Effectiveness Evaluation of Isolator Systems and Restricted Access Barrier Systems

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…

Difference Between RABS and Isolator

Difference Between RABS and Isolator

RABS (Restricted Access Barrier System) and isolators are both important containment systems used in pharmaceutical manufacturing to protect products from contamination and ensure operator safety. Let’s take a closer look at their specifications, applications, and qualification tests.   Specifications – RABS: RABS is a semi-closed system that creates a physical barrier between the operator and…