The invention relates to an arrangement for the sterile/aseptic production and/or filling of pharmaceutical products.
The term pharmaceutical products is understood to mean e.g. syringes, vials, carpules etc., which must be filled with a liquid or solid medium in an aseptic/sterile environment. For this purpose the containers must undergo several process steps, e.g. filling with a medium, closing and so on. All these processes must take place in a sterile and/or aseptic environment.
For this purpose it is known to use so-called isolators, i.e. arrangements where the process stations are contained in a closed casing. Access to the interior of said casing takes place by means of glove interventions, the inserting of components by RTP-Ports (Rapid Transfer Ports). The process stations are flooded with a directional airflow with a low particle content from an air supply unit and the air return takes place in closed ducts.
Such arrangements, devices or plants operate with high reliability, but are very expensive due to their complicated structure and have long validation periods and high validation volumina.
In addition, open systems are known, where the process stations are scavenged with a directional airflow with a low particle content from an air supply unit and without airflow return in closed ducts. Curtains and doors are provided to delimit the same from the surrounding area.
Open systems referred to in the technical literature as Restricted Access Barriers Systems (RABS) are also known. In simplified terms, these are isolator-like arrangements with openings at the bottom. Here again the process stations are scavenged with a directional, low particle content airflow from an air supply unit, but the airflow is not returned. These systems exclusively operate as displacement systems without an overpressure. The demarcation with respect to the surrounding area is provided by closable or sealable viewing windows and viewing doors. Access to such systems is only possible by glove interventions.
Open systems without air return are less expensive than isolators, but do not bring about the high product environment reliability and safety obtained with isolators.
The problem of the invention is to provide an arrangement for the sterile/aseptic production and/or filling of pharmaceutical products, which on the one hand ensures a high safety and reliability for the product to be handled similar to the isolators, but which on the other incurs lower costs and has shorter validation periods and lower validation volumina.
USPTO Backgrounds
USPTO Backgrounds