Are Restricted Access Barrier Systems (RABS) and isolators superior to traditional cleanrooms?
Isolators emerged in the 1990s but fell short of expectations, leading to the development of RABS to serve as an alternative. Aseptic processing since has evolved into a diverse manufacturing technology with at least three major means of creating a sterile environment: aseptic clean rooms, Restricted Access Barrier System (RABS), and isolators. Despite the FDA’s assertion in their principle aseptic processing guidance document that isolators are superior in their ability to control contamination, there is a great deal of disagreement in the industry regarding the comparative effectiveness of each system.
All three have equal aseptic requirements. Many companies, especially large pharmaceutical companies, are switching from cleanrooms to isolators or RABS, but opponents of the trend say that RABS and isolators actually increase sepsis.
Weighing the Options
Isolators have regained some favor in the past few years, boosted by better technology and a reduced cleaning cycle. An isolator can serve as an alternative to a sophisticated cleanroom. Manufacturers generally use isolators in applications that require a great deal of protection from contaminants or external elements, as this equipment creates a nearly complete separation between a product and its production equipment, personnel, and surrounding environment. Isolators maintain a light, positive air pressure that prevents contaminants from entering through any openings while workers perform duties through glove isolators.
Isolators are preferable in processes requiring a built-in air filtration system that can significantly lower particle count in an enclosed area. Manufacturers working in small spaces appreciate the compact size of isolators and the ease of cleaning with gas or vaporizer sterilizing agents. An isolator has an automated bio-decontamination system that utilizes vaporized hydrogen peroxide, whereas cleaning RABS is a manual process.
RABS are in an open environment, where air flows freely out of the RABS to the surrounding room. People are the largest source of contamination in a cleanroom, so isolators and RABS serve as a physical barrier between people and the filling process.
RABS give workers more flexibility because they can open doors – one of the main problems with isolators is that the operator cannot access the process while it is running. There is an emerging trend of RABS units without glove isolators, as gloves can present more work, increased risk for contamination, and glove failures within the isolator system.
RABS and isolators tend to be more costly than traditional cleanroom. In many cases, RABS are a new type of equipment that employees must learn to maintain and operate correctly. Maintaining a cleanroom can be expensive, as well, when accounting for the costs of operating, energy, and testing that ensure the entire room is clean.
The costs for cleanrooms are well defined, but cleanroom installation can pose substantial expenses for engineering, ventilation, heat, and air conditioning. Compared with cleanrooms, RABS have higher equipment-related, operating, and overall costs. Isolators generally cost more to install and operate, and present additional costs for vaporized hydrogen peroxide and the time used for bio-decontamination, but RABS may present cost savings in gowns, supplies, and monitoring.
The time for qualification can take six to nine months for a barrier isolator, whereas qualifying cleanrooms is straightforward and quick.
The industry is undecided when it comes to choosing between cleanrooms, RABS, and isolators. Each manufacturer must weigh the benefits and disadvantages of each system.
Source: http://www.fda.gov/downloads/Drugs/…/Guidances/ucm070342.pdf, http://www.americanpharmaceuticalreview.com/Featured-Articles/36878-Clean-Rooms-RABS-and-Isolators-Validation-and-Monitoring-in-the-Diverse-World-of-Aseptic-Processing/