Restricted Access Barrier System
In the pharmaceutical sector, the restricted access barrier system is credited for assisting manufacturers to ensure a high level of sterility to in the production of drugs and drug products. The system's rationale is grounded on the need for pharmaceutical manufacturers to adopt strict standards in assuring that the drugs produced are free of all contamination or infectivity risk. The importance of the barrier system is reinforced by the regulations placed on manufacturers to ensure that the final product is safe for patients. Apart from ensuring the optimum possible level of sterility is achieved in the manufacture of drugs, the restricted access barrier system is capable of preventing cross-contamination in aseptic production.
The restricted access barrier system emerged in the mid-90s and almost replaced its predecessor, the isolator, due to its enhanced capabilities and cost considerations. This system, in particular, has enhanced capabilities in terms of allowing for faster startup time, ensuring a changeover is effected with ease, and guaranteeing reduced capital costs. Available pharmaceutical scholarship demonstrates that any system making claims that it qualifies as a restricted access barrier system must meet stringent conditions, which include adopting quality-designed equipment and tools, ensuring all machine operators receive ample education and training of best practices including appropriate gowning practice, using high-level disinfection to achieve a high level of sterility, and adopting extremely automated processes and clearly articulated approaches for rare open-door initiatives.
The restricted access barrier system must also have capabilities in thwarting human intervention straightforwardly into the critical zone, particularly in terms of providing an adequate level of disconnection between the machine operator and the drug product to achieve optimal product protection. It is important to note that the automation of the system is critical in minimizing operator-centered variability, thus making the whole process reproducible. Furthermore, the system must have the capacity to act as a conventional clean room through the use of HEPA filtered unidirectional air to achieve an ISO 5 classified space for use in the production of drugs. Lastly, the system must make provisions for glove port access for machine operators, whereby grove ports, sleeves and gloves are fastened to the unit's walls not only to separate the machine operator from the sterile internal environment of the system but also to enhance superior visibility and guarantee safety.
In the restricted access barrier system, pre-sterilized tools and components are initiated into the system using aseptic processes that include accessible built-in transfer protocols, stainless steel walls, and double door airlocks. The blend of these physical and aerodynamic blockades ensure that the restricted access barrier system is able to avert ingress of harmful contaminants, toxins and impurities into the internal environment. In most pharmaceutical companies, the system is normally used to enclose a drug manufacturing facility to avoid contamination and assure a toxin-free environment.
Overall, it is clear that the restricted access barrier system is instrumental in enhancing patient safety and ensuring product quality by providing a sterile environment for the production of drugs and drug-related products. The system is effective in assuring companies manufacture quality products that meet and probably surpass the expectations of patients on safety.
