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Improved RABS concept combines two proven aseptic processes

Improved RABS concept combines two proven aseptic processes

Today, two distinct technologies are used to enable high-quality aseptic filling: isolators and restricted access barrier systems (RABS). Isolators are often considered the best solution for a high level of sterility, whereas RABS permit greater flexibility and higher-capacity utilization of filling lines when running multiple products.

The changing manufacturing and regulatory requirements of today’s compounds create a need for improved solutions in quality and flexibility:
Complex compounds, such as monoclonal antibodies, vaccines, and recombinant peptides, are extremely sensitive to their environments, so manufacturers need to find processes that offer even more reliable protection against microbiological impurities and cross-contamination. At the same time, the trend toward smaller batches of these compounds demands greater flexibility in manufacturing processes.  

Isolator technology

Processing takes place in systems that are entirely shut off from the outside environment. Isolators need extensive decontamination and preparation processes following a batch to enable a safe change in product.

RABS technology

The physical barriers of a production plant are limited, requiring installation in a higher-class environment (at least ISO 7, with the RABS located in an ISO 5 area). RABS technology allows greater flexibility in the manufacturing process.

The Improved RABS Concept to combine quality and flexibility

This new approach, called the Improved RABS Concept, combines the decontamination advantages of isolators with the flexibility of RABS. The heart of this approach is an automated decontamination of the cleanroom using hydrogen peroxide (H2O2) that can be performed after each batch. This approach achieves safety and quality standards that well exceed cGMP and are competitive with isolator performance.

Filling line with RABS technology

Jet used for H2O2 decontamination

Running H2O2 decontamination process

The Improved RABS Concept creates a virtual “walk-in isolator,” a two-barrier concept for risk mitigation. The cleanroom staff works in a Class 10,000 area that can be entered only after proper gowning and passage through a series of personnel air locks. Beyond the first protective barrier, the RABS encases the filling line within an ISO 5 area. This robust process means deviations such as a pinhole in a glove will not necessarily lead to the loss of a batch.

Simplified drawing of a two-barrier RABS operation

Vetter pioneered the Improved RABS system

Vetter’s goal is to provide reliable, repeatable aseptic processes for its customers with production methods that make economic sense. When improving its plants or introducing new manufacturing concepts, Vetter carefully balances the individual needs of its individual customer products with the need to align with regulatory and economic demands.

Vetter has relied on RABS technology for decades and is the innovator behind the Improved RABS Concept. The incorporation of daily, fully automated decontamination allows for completion of a 6-lg spore-decontamination process with a 3-hour cycle (uniquely fast by today’s standards). This reduced downtime increases capacity utilization and overall equipment effectiveness. The Improved RABS Concept was first implemented in a cleanroom at Vetter’s Ravensburg Schuetzenstrasse facility and, based on positive results, will be implemented in all of its cleanrooms in the near future.