The sterility test isolators from Metall+Plastic are easy to adjust to customer requirements due to their modular design. The standard version includes four glove ports in the isolator chamber. Isolator chambers with two or three glove ports are also available. The MTC (Material Transfer Chamber) can be installed to the left or the right of the chamber or on both sides. The MTC can also be retrofitted later. 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. 

Ergonomic design

To minimise physical stress for the operators, the designers for the STISO placed an emphasis on ergonomic design. An ergonomic study was performed in cooperation with Scala Design and the results were incorporated into the design of the sterility test isolator. Therefore, the operator panel is at an optimal height, it is pivotable and angle adjustable. In addition, the machine allows for sufficient legroom. 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. Additional options are: particle monitoring, air sampler, sterility test pumps and scales.

Highly active agents like Cytotoxic for live vaccines, viruses and bacteria are becoming more and more vital. It is critical to guarantee the operator’s and the product’s safety while processing toxic substances. This is accommodated, for exampe, busing HPT filters from Metall+Plastic. The filters separate the airborne particles from the product. The HPT filters are able to handle a volume flow of about 1300m³/h  in H13 or optional in H14 quality. Filters are lightweight and easy to change. They also offer the opportunity to perform an integrated filter integrity test and the plastic paneling can be burned without any residue.

User requirements were also considered during the design of the glove testing units; they are integrated on the side of the panel to make the operation easy. Inspection covers are integrated on the side of the system, are soon ready-for-use quickly and stowed-away quickly. The software for the testing unit is integrated into the HMI.

Reduced cycle times

Another benefit for the operator is the shortened cycle times that are the result of catalytic ventilation. This ventilation ensures that the H2O2 used for the isolator decontamination is removed quickly. The evaporation system RGx enriches the pre-conditioned carrier air with H2O2 and blows it into the STISO. Due to the catalytic ventilation, the Metall+Plastic system obtains time-savings of several hours, depending on the expected remaining H2O2 concentration. This is achieved by a constant air circulation with a catalytic converter that absorbs H2O2 and removes it continuously during the operation. 

The STISO creates a maintenance-friendly so-called flash evaporation. With the patented DECOjet process from Metall+Plastic, the liquid H2O2 will be transformed into a gaseous state. Hardly any maintenance work is needed in the evaporator area. No residues were determined within half a year during the recommended maintenance interval. 

Manufacturers of highly active substances are able to design their sterility tests efficiently and securely. The modular design permits adjustment to the particular room conditions and staff requirements. The company says this offers an efficient workspace without fatiguing personnel, and which will eventually benefit your sterility tests and quality control.