What is the difference (use ,structure, advantages - disadvantages)between Isolator and RABS in drug product mamufacturing?

Have tried to find sth useful online but thinking even get more confused.
Look for help!

Hello Lisa, and welcome.

Isolators and RABS are intended to use as barrier systems to reduce the risk of contamination; and in case of isolators, they could also be used for containment, like for high potency products.

Whenever there is the need in your facility design to use a barrier system, it is usually best to consider an isolator (for example, aseptic processing) given that this technology “isolates” the critical area so that any particle from the environment surroinding the isolator cannot enter.

RABS ar barrier systems and can be open or closed, but these cannot fully enclose an area like an isolator. These are used when there is need for barrier system but the design of the process cannot support fully enclosed area (isolator). for example, in the manufacture of sterile preparations (USP 797) the operation required to have a flow of materials that entails some level of communication with the environment surroindung the RABS.

In conclusion, an isolator gives better protection against contamination, but RABS could give you mor flexibility in therms of operating inside the critical area. Industry is moving forward to isolator technology a lot, including automatic solutions for operating processes; so an isolator would be the prefered choice to protect your product for contamination in those instances where the need of a barrier system is present, unless there is a specific need for a RABS.

The new Annex 1 for sterile GMP of PIC/S can give you a better understaing in regards to the risks of contamination and the regulatory requirements of each type of barrier technology.

Having said this, if you have a more specific question, perhaps some of us could be of more help.