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 the product. It typically includes features like glove ports, curtain walls, and air handling systems. RABS allows limited access to the product during operations.
- Isolators: Isolators, on the other hand, are fully enclosed systems with airtight seals that completely isolate the product from the external environment. They often have built-in gloves or robotic arms for handling materials inside. Isolators provide a higher level of containment compared to RABS.
Main Applications
- RABS: RABS is commonly used in pharmaceutical manufacturing for aseptic processing tasks such as filling, closing, and labeling of sterile products. It creates a controlled environment to minimize the risk of contamination while still allowing some operator intervention.
- Isolators: Isolators are primarily used for highly potent or hazardous drug manufacturing, where complete isolation is necessary to protect operators from exposure to toxic substances. They are also utilized for aseptic processing of sterile products when a higher level of containment is required.
Qualification Tests
- RABS: The qualification tests for RABS include measurements of air velocity and pressure differentials, microbial challenge tests, leak tests, and particle count tests. These tests ensure that the RABS system maintains the required cleanliness and containment levels.
- Isolators: The qualification tests for isolators are more extensive due to their higher level of containment. They involve measurements of air velocity and pressure differentials, microbial challenge tests, leak tests, particle count tests, glove integrity tests, and decontamination cycle validation. These tests guarantee the integrity of the isolator and its ability to maintain sterility and containment.
In conclusion, RABS and isolators are both crucial containment systems used in pharmaceutical manufacturing. While RABS provides a semi-closed system with limited access to the product, isolators offer complete isolation and are ideal for highly potent or hazardous drug manufacturing. The qualification tests for isolators are more comprehensive due to their higher level of containment.
Read also: Difference Between Hazard and Risk in Pharmaceutical QRM
Resource Person: Ershad Moradi
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