Maintaining aseptic conditions in the pharmaceutical and medical industry is of utmost importance in order to avoid any contamination to product. Cleanrooms provide this feature, but in most of the cases these incur high capital.
Restricted barrier access system (RABS), introduced around 1995, is a setup which isolates the operator from the operational area, as humans (operator) are supposed to be the major carriers of contaminating agents. Since its introduction, RABS systems have found applications in industries such as pharmaceutical, medical, and chemical.
According to guidelines set up by the International Society for Pharmaceutical Engineering (ISPE), RABS system should provide an airflow of ISO5, it should provide physical barrier for human interventions in the critical zone, and have automated processes and procedures.
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Demand for RABS system is expected to rise in the next few years driven by features such as provision of aseptic safety in critical zone of an isolator and flexibility for interventions like cleanroom. Moreover, efficiency and less capital investment compared to isolator and cleanroom are expected to propel demand for restricted access barrier system in the near future.
The rules and regulations for manufacturing procedure are getting stringent with demand for aseptic and efficient pharmaceutical and medical products, also with need for safety in research and development and manufacturing from toxic and viral product agents is rising which is expected to drive the business for restricted access barrier systems in near future. However, high cost of installation and components and high cost of maintenance are expected to hamper the growth of the global RABS market.
Additionally, limited number of suppliers and requirement of trained operators are expected to restrain the global restricted access barrier system market.
The global restricted access barrier system market can be segmented based on type of ventilation and air outlet. Based on type of ventilation, the market can be segmented into passive RABS and active RABS.
Passive RABS uses filtered and purified air from cleanroom. This system does not have its own air filters and air conditioning system.
Active RABS uses HEPA filter incorporated in the system to provide filtered air and even air-flow distribution in critical area. In terms of air outlet, the market can be segmented into open RABS and closed RABS.
Open RABS spills the air passed through its critical zone into cleanroom without any further filtration. While closed RABS recirculates the critical area passed air to its HEPA filters and spills the filtered air into cleanroom.
Most of the active RABS setups are closed systems.
In terms of region, the global restricted access barrier system market has been segmented into North America, Europe, Asia Pacific, and Rest of the World. North America is expected to account for major share of the global RABS market.
The market in the region is expected to expand at a higher rate owing to presence of major pharmaceutical and biotechnology organizations and demand for safe, aseptic, and standard manufacturing and research processes. Europe is expected to be the second largest market for restricted access barrier system driven by growing industry and stringent manufacturing rules and regulations.
The restricted access barrier system market in Asia Pacific is expected to witness strong growth in the near future attributed to emerging economies such as China and India.
Major players in the global restricted access barrier system market are IMA S.p.A., AZBIL TELSTAR, S.L.U., Comecer S.p.A., Robert Bosch GmbH, Extract Technology, Ortner Reinraumtechnik GmbH, Germfree, Tofflon Science and Technology Co., Ltd., and Isolation Systems, Inc., among others.
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