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The sterility test isolator (STISO) for testing aseptically filled drug products and for testing toxic aseptic drugs (STISOtox) from Metall+Plastic, a subsidiary of Optima, are modular and ergonomically designed.
Product safety is the focal point during the filling of pharmaceutical products. Sterility test isolators are used to check the purity and sterility of filled batches and to increase safety. New sterility test isolators from Metall+Plastic, a subsidiary of Optima, were designed as plug & play isolators for aseptic (STISO) and aseptic-toxic (STISOtox) applications.
The sterility test isolators are easy to adjust to customer requirements due to their modular design. The standard version includes four glove ports in the isolator chamber, but it is also available with two or three glove ports. The material transfer chamber (MTC) can be installed to the left or the right of the chamber or on both sides. The MTC can also be retrofitted at a later date. It comes in two different sizes in the standard version. The STISO can be operated from one side and, therefore, is suitable for space saving installation against the wall, allowing the STISO to be used for small batches. Additional options that can be included are: particle monitoring, air sampler, sterility test pumps, and scales.
The results of an ergonomic study were incorporated into the design of the STISO: the operator panel is at an optimal height, and it is pivotable and angle adjustable. In addition, the machine allows for sufficient legroom. The insertion heights can be adjusted to match the operator’s height. It is also possible to work in a sitting position with an ergonomically designed pivoting chair. Operators also benefit from the loading cart and trolley. The STISO glove testing units are integrated on the side of the housing to make the operation easy.
While processing toxic substances for live vaccines, viruses, and bacteria, it is crucial to guarantee the operator’s and the product’s safety. HPT filters from Metall+Plastic separate the airborne particles from the product and can handle a volume flow of approximately 1300 cubic meters per hour. The filters offer the opportunity to perform an integrated filter integrity test, and the plastic housing can be burned without any residue.
The unit offers short cycle times using catalytical ventilation to ensure that the hydrogen peroxide used for the isolator decontamination is removed quickly. The STISO uses maintenance-friendly flash evaporation. With the patented DECOjet process from Metall+Plastic, the liquid hydrogen peroxide is transformed into a gaseous state. The advantage is that little maintenance work is needed in the evaporator area.